Genito-Urinary Disease Site

The Canadian Cancer Trials Group Central Operations and Statistics Centre will be closed on Friday, April 19, 2019 for Good Friday. Regular business hours will resume on Monday, April 22 at 8:30 am EDT.
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PR21PLUDO (Prostate Lutetium/Docetaxel): A Randomized Phase II Study of 177Lu-PSMA-617 vs Docetaxel in Patients with Metastatic Castration-Resistant Prostate Cancer and PSMA-Positive Disease


Complexity Level: 2

Eligibility: Inclusion: 1. Progression on treatment with abiraterone and/or enzalutamide, or similar next generation androgen receptor (AR) targeted therapy 2.Evidence of PSMA positive metastatic disease, as assessed on PSMA-ligand PET/CT or PSMA-ligand PET/MR 3. Biopsy-proven prostate cancer with no evidence of small cell component 4. Prior orchiectomy, or if on LHRH agonist/antagonist then testosterone 5. Patients must have castration resistance with prior evidence of biochemical or imaging progression in the setting of surgical/medical castration

Objectives: (Primary): To compare progression free survival (PFS) of patients with mCRPC following 177Lu-PSMA radioligand therapy vs. docetaxel in the post AR-targeted therapy setting (Secondary):proportion of patients that are progression free at 6 months (Secondary):overall survival (Secondary): proportions of patients with decreased PSA from baseline and the magnitude of change (Secondary):determine the clinical benefit rate (CBR), including partial response (PR), complete response (CR) or stable disease >24 weeks (RECIST v1.1). (Secondary):describe the adverse event (AE) profile of protocol therapy (Secondary):determine patient reported quality-of-life (QoL) while on treatment (Tertiary): explore biomarkers of response and resistance using cell free DNA (Tertiary): retrospectively explore a dosimetry-based approach to determine administered activity.

NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: CCTG Led Trial
Status: Planned

Chair: (Canada) Dr. Fred Saad, CHUM-Centre Hospitalier de l'Universite de Montreal, (514) 890-8000 Ext. 27466, (Canada) Dr. Kim Chi, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2746


Planned
PR22 (ANZUP 1801)Darolutamide Augments Standard Therapy for Localized High-Risk Cancer of the Prostate (DSAL-HiCaP)


Complexity Level: 2

NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Planned

Planned
BL13A Randomized Phase II Trial Assessing Trimodality Therapy With or Without Adjuvant Durvalumab (MEDI4736) to Treat Patients with Muscle-Invasive Bladder Cancer
This study is looking at whether a new type of drug called durvalumab can be used in combination with the initial treatment patients receive. Recently, clinical trials have shown that a drug similar to durvalumab can help some patients with bladder cancer especially in combination with prior treatment.

Complexity Level: 2

Eligibility: Histologic diagnosis of transitional cell carcinoma of the bladder with completion of prior trimodality therapy (surgery, chemotherapy and radiation)at least 42 days prior to study enrollment. Stage T2-T4a N0M0.

Objectives: The overall objective of this phase II randomized trial is to determine if Durvalumab when used in combination following standard trimodality therapy improves disease-free-survival in patients with muscle-invasive bladder cancer who are electing for bladder-sparing treatment.

NCT Registration ID (from clinicaltrials.gov): NCT03768570
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: Open to Accrual
Activation Date: December 21, 2018

Chair: (Canada) Dr. Wassim Kassouf, The Research Institute of the McGill University, (514) 934-8246


Open to Accrual
BLC4 (SWOG S1605)Phase II Trial of Atezolizumab in BCG-Unresponsive Non-muscle Invasive Bladder Cancer
Testing the use of Atezolizumab in Non-Muscle Invasive Bladder Cancer that has Not Responded to Prior Bacillus Calmette-Guerin (BCG) Therapy

Complexity Level: 2

Eligibility: Patients with histologically proven, recurrent, non-muscle invasive urothelial carcinoma of the bladder within 60 days prior to registration. The carcinoma must be Stage T1 High-Grade, Stage CIS, or Stage Ta High-Grade. Patients with mixed urothelial carcinoma and a glandular and/or squamous component will be eligible for the trial, but the presence of other histologic variants, pure adenocarcinoma, or pure squamous cell carcinoma, will make a patient ineligible. Patients must be deemed unfit for radical cystectomy by the treating physician, or the patient must refuse radical cystectomy, which is considered standard of carefor these patients. The reason for patients not to undergo cystectomy will be clearly documented.

Objectives: Complete response at 25 weeks after registration for those with a CIS component; event-free survival at 18 months in patients with BCG-unresponsive high-risk non-muscle invasive bladder cancer (Ta/T1/CIS)treated with atezolizumab. To estimate event-free survival at 18 months for the subset of patients with papillary cancer (Ta/T1). Progression-free survival, cystectomy-free survival,bladder cancer specific survival, overall survival in all patients.

NCT Registration ID (from clinicaltrials.gov): NCT02844816
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Open to Accrual
Activation Date: April 07, 2017

Chair: (Canada) Dr. Peter Black, Clinical Research Unit at Vancouver Coastal, (604) 875-5003, (Canada) Dr. Wassim Kassouf, The Research Institute of the McGill University, (514) 934-8246


Open to Accrual
I223A Phase II Study of Palbociclib, A CDK4/6 Inhibitor, in Patients with Metastatic Castration-Resistant Prostate Cancer
The purpose of this study is to find out what effects a new drug, palbociclib, has on prostate cancer and will look at the side effects of treatment with palbociclib. The researchers doing this study are also interested in looking for markers that may help predict which patients are most likely to be helped by palbociclib and to see how the cancer cells respond to palbociclib.

Complexity Level: 1

Eligibility: Patients (>=18 years old, ECOG PS 0-1) must have histologically confirmed mCRPC with no evidence of small cell/neuroendocrine differentiation. Patients will be pre-screened for CCDN1 amplification and RB1 status. Clinically/radiologically documented disease (measurable or non-measurable). Evidence of biochemical and/or radiological disease progression in the setting of surgical or medical castration. Patients must have received prior hormonal treatment with at least one of abiraterone acetate, enzalutamide, ARN-509 TAK-700 and TOK-001. Prior anti-androgen therapy must have been discontinued >=28 days (>=42 days for bicalutamide) prior to registration. Maximum of one prior regimen of cytotoxic chemotherapy permitted. Prior immunotherapy, vaccines and oncolytic viruses permitted. Prior/concurrent CDK or mTOR inhibitors, strontium-89, systemic corticosteriods equivalent to prednisone >10 mg daily not allowed. Potent/strong CYP3A inhibitors/inducers not allowed.

Objectives: PRIMARY - To assess the clinical benefit rate (CBR) of palbociclib in patients with metastatic, castration-resistant prostate cancer (mCRPC). SECONDARY - (1) To determine the effect of palbociclib on PSA decline and time to PSA progression; (2) To determine objective response as determined by RECIST 1.1 criteria; (3) To evaluate the safety and toxicity profile of palbociclib in mCRPC patients. EXPLORATORY - (1) To determine whether CCND1 gain/amplification in plasma cell-free DNA (cfDNA) (+/-RB1 wild type) is predictive of CBR to palbociclib; (2) To evaluate gene copy number variation and mutation profile of cfDNA in patients with mCRPC before and after treatment with palbociclib; (3) To identify potential predictive and prognostic blood-based RNA markers.

NCT Registration ID (from clinicaltrials.gov): NCT02905318
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: Open to Accrual
Activation Date: February 09, 2017

Chair: (Canada) Dr. Kim Chi, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2746


Open to Accrual
I234Prostate Cancer Biomarker Enrichment and Treatment Selection (PC_BETS) Study - Master Screening Protocol
The purpose of the pre-study screening is to test for DNA abnormalities or "markers". This testing will be done on a sample of your blood to see whether or not you are eligible to take part in one of the main studies. Each study will be looking at what effects a new drug or drugs has on you and your prostate cancer and will also be looking at the side effects of treatment. The researchers doing the main studies will be looking to see if the "markers" that were identified in your screening sample can help predict which patients are most likely to be helped by that drug or drugs and to see how the cancer cells respond to it/them.

Complexity Level: 1

Eligibility: Patients (>=18 years old, ECOG PS 0-1) must have histologically confirmed mCRPC with no evidence of small cell/neuroendocrine differentiation. Patients must consent to undergo genomic screening. Clinically/radiologically documented disease (measurable or non-measurable). Evidence of biochemical and/or radiological disease progression in the setting of surgical or medical castration. Patients must have received prior hormonal treatment with at least one of abiraterone acetate, enzalutamide, ARN-509 TAK-700 and TOK-001. Prior anti-androgen therapy must have been discontinued >=28 days (>=42 days for bicalutamide) prior to registration. Maximum of one prior regimen of cytotoxic chemotherapy permitted. Prior immunotherapy, vaccines and oncolytic viruses permitted. Prior/concurrent CDK or mTOR inhibitors, strontium-89, systemic corticosteriods equivalent to prednisone >10 mg daily not allowed.

Objectives: Primary Objective - To centrally genotype cfDNA from patients with mCRPC progressing after a "next-generation" AR-pathway inhibitor in order to facilitate accrual to targeted therapy trials and then to assess the clinical benefit rate (CBR), of each Study Drug. Secondary Objectives - To determine the effect of each Study Drug on PSA decline and time to PSA progression. To determine objective response as determined by RECIST 1.1 criteria. To evaluate the safety and toxicity profile of each Study Drug in mCRPC patients. Tertiary Objectives - To obtain cfDNA and non-malignant DNA from peripheral blood clinically annotated with patient disease characteristics and follow-up data to identify potential predictive and prognostic factors and relationship between cfDNA results with clinical presentation.

NCT Registration ID (from clinicaltrials.gov): NCT03385655
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: Open to Accrual
Activation Date: December 12, 2017

Chair: (Canada) Dr. Kim Chi, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2746


Open to Accrual
I234BA Phase II Study of Savolitinib, A CMET Inhibitor, in Patients with Metastatic Castration-Resistant Prostate Cancer - A Sub-Study of IND.234
The purpose of this study is to find out what effects a new drug, savolitinib, has on prostate cancer and will look at the side effects of treatment with savolitinib. The researchers doing this study are also interested in looking for markers that may help predict which patients are most likely to be helped by savolitinib and to see how the cancer cells respond to savolitinib.

Complexity Level: 1

Eligibility: Patients must meet the following criteria in addition to the eligiblity criteria outlined in IND.234.Men of childbearing potential must have agreed to use a highly effective contraceptive method during Study Drug treatment and for 6 months after stopping treatment and should not father a child or donate sperm during this period. Patients with significantly abnormal liver diseases including viral/other hepatitis, current alcohol abuse or cirrhosis are not eligible. Patients in whom strong inducers or inhibitors of CYP3A4 and strong inhibitors of CYP1A2 cannot be discontinued within 2 weeks before the first dose of savolitinib (3 weeks for St John's Wort) are not eligible..

Objectives: To determine the effect of savolitinib on PSA decline and time to PSA progression. To determine objective response as determined by RECIST 1.1 criteria. To evaluate the safety and toxicity profile of savolitinib in mCRPC patients. Tertiary Objectives To obtain cfDNA and non-malignant DNA from peripheral blood clinically annotated with patient disease characteristics and follow-up data to identify potential predictive and prognostic factors and relationship between cfDNA results with clinical presentation.

NCT Registration ID (from clinicaltrials.gov): NCT03385655
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: CCTG Led Trial
Status: Open to Accrual
Activation Date: December 12, 2017

Chair: (Canada) Dr. Som Mukherjee, Juravinski Cancer Centre at Hamilton Health Sciences, (905) 387-9495 Ext. 64605


Open to Accrual
I234CA Phase II Study of Darolutamide (ODM-201) in Patients with Metastatic Castration-Resistant Prostate Cancer Previously Treated with Abiraterone Acetate or Enzalutamide - A Sub-Study of IND.234
The purpose of this study is to find out what effects a new drug, darolutamide, has on prostate cancer and will look at the side effects of treatment with darolutamide. The researchers doing this study are also interested in looking for markers that may help predict which patients are most likely to be helped by darolutamide and to see how the cancer cells respond to darolutamide.

Complexity Level: 1

Eligibility: Patients must meet the following criteria in addition to the eligiblity criteria outlined in IND.234. Serum potassium within normal limits. Prior abiraterone acetate or enzalutamide but not both. No prior cytotoxic systemic chemotherapy in the CRPC setting.

Objectives: To determine the effect of darolutamide on PSA decline and time to PSA progression. To determine objective response as determined by RECIST 1.1 criteria. To evaluate the safety and toxicity profile of darolutamide in mCRPC patients. Tertiary Objectives To obtain cfDNA and non-malignant DNA from peripheral blood clinically annotated with patient disease characteristics and follow-up data to identify potential predictive and prognostic factors and relationship between cfDNA results with clinical presentation.

NCT Registration ID (from clinicaltrials.gov): NCT03385655
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: CCTG Led Trial
Status: Open to Accrual
Activation Date: December 12, 2017

Chair: (Canada) Dr. Michael Ong, Ottawa Hospital Research Institute, (613) 737-7700 Ext. 75051


Open to Accrual
I234DA Phase II Study of CFI-400945 Fumarate in Metastatic Castration-Resistant Prostate Cancer (mCRPC)
The purpose of this study is to find out what effects a new drug, CFI-400945, has on prostate cancer and will look at the side effects of treatment with CFI-400945. The researchers doing this study are also interested in looking for markers that may help predict which patients are most likely to be helped by CFI-400945 and to see how the cancer cells respond to CFI-400945.

Complexity Level: 1

Eligibility: Patients must meet the following criteria in addition to the eligibility criteria outlined in IND.234. All patients must have a formalin fixed paraffin embedded tissue block (from primary or metastatic tumour) available and must have provided informed consent for the release of the block.

Objectives: Primary Objectives To determine the effect of CFI-400945 on PSA decline and time to PSA progression. To determine objective response as determined by RECIST 1.1 criteria. Tertiary Objectives To obtain cfDNA and non-malignant DNA from peripheral blood clinically annotated with patient disease characteristics and follow-up data to identify potential predictive and prognostic factors and relationship between cfDNA results with clinical presentation. To evaluate the safety and toxicity profile of CFI-400945 in mCRPC patients.

NCT Registration ID (from clinicaltrials.gov): NCT03385655
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: CCTG Led Trial
Status: Open to Accrual
Activation Date: December 12, 2017

Chair: (Canada) Dr. Aaron Hansen, University Health Network, (416) 946-4501 Ext. 3426


Open to Accrual
PNC1 (ECOG-ACRIN EA8134)InPACT: International Penile Advanced Cancer Trial
Testing Combinations of Surgery, Chemotherapy, and Chemotherapy with Radiation for Cancer of the Penis that has Spread to Lymph Nodes

Complexity Level: 2

Eligibility: (1) Male, aged 18 years or older, (2) Histologically-proven squamous cell carcinoma of the penis. (3) Stage: any T, N1 (i.e. a palpable mobile unilateral inguinal lymph node), M0, OR; any T, N2 (i.e. palpable mobile multiple or bilateral inguinal lymph nodes), M0 OR; any T, N3 (i.e. fixed inguinal nodal mass or any pelvic lymphadenopathy), M0, (4) Measurable disease as determined by RECIST (version 1.1) criteria, (5)Performance Status ECOG 0, 1 or 2, (6) Patient is fit to receive the randomisation options for which he is being considered. (7) adequate hematology, biochemistry, liver function, renal function tests, and patient must be suitable for randomization options. EXCLUSION: Pure verrucous carcinoma of the penis; Non-squamous malignancy of the penis; Squamous carcinoma of the urethra; Stage M1; Previous chemotherapy or chemoradiotherapy outside of the InPACT trial.

Objectives: Primary objective: (1) (a) Is there a role for neoadjuvant therapy and, if so, (b) does CT or CRT produce superior outcomes (2) What is the additional survival benefit of PLND given after neoadjuvant s or with adjuvant CRT of the pelvic nodes over and above that of chemoradiotherapy alone in patients at high risk of recurrence following ILND? Secondary objectives: In InPACT-neoadjuvant: (a) Can neoadjuvant therapy prior to surgery (ILND) reduce recurrence rates? (b) Which is the more active of neoadjuvant CT or neoadjuvant CRT? (c) What is the op/post-op complication rate following neoadjuvant therapy of both types? (c) Is neoadjuvant CRT feasible in this setting? In InPACT-pelvis: (a) What is the rate of additional complications for the combination of PLND and CRT? Exploratory objectives: (a) What is the relationship between HPV status and outcome for all groups studied? (b) What is the impact on QOL of (sequential) treatments studied?

NCT Registration ID (from clinicaltrials.gov): NCT02305654
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Open to Accrual
Activation Date: May 30, 2018

Chair: (Canada) Dr. Juanita Crook, BCCA - Cancer Centre for the Southern Interior, (250) 712-3900 Ext. 3979


Open to Accrual
PR19A Randomized Phase II Trial Evaluating High Dose Rate Brachytherapy and Low Dose Rate Brachytherapy as Monotherapy in Localized Prostate Cancer
The purpose of this study is to evaluate high dose rate (HDR) and low dose rate (LDR) brachytherapy given as monotherapy with respect to tumour control, toxicity, quality of life, and economic impact.

Complexity Level: 1

Eligibility: Patients enrolled in this study must have histologically confirmed adenocarcinoma of the prostate diagnosed within the last 9 months and have low- (clinical stage T1-T2 and Gleason 6 and PSA <20 ng/mL) or intermediate-risk (clinical stage T1-T2 and Gleason 7 (3+4) and PSA < 15 ng/mL and < 50% of positive cores) prostate cancer.

Objectives: Primary objective: prostate cancer control as defined by 48 month PSA values Secondary objectives: Disease-free survival, acute and long term toxicity and safety, Quality of Life (QOL) of the patient and their spouse/partner, resource utilization and economic indices of treatment administration. Tertiary objective: To establish a comprehensive tumour bank linked to a clinical database for the further study of predictive and prognostic biomarkers in prostate cancer.

NCT Registration ID (from clinicaltrials.gov): NCT02960087
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: CCTG Led Trial
Status: Open to Accrual
Activation Date: November 04, 2016

Chair: (Canada) Dr. Eric Vigneault, CHUQ - Hotel Dieu de Quebec, (418) 691-5264, (Canada) Dr. Gerard Morton, Odette Cancer Centre, (416) 480-6165


Open to Accrual
PR20A Randomized Phase III Trial of Local Ablative Therapy For Hormone Sensitive Oligometastatic Prostate Cancer [PLATON]
Comparing standard treatment to standard treatment plus ablative therapy (radiation or surgery) to all sites of disease for patients with hormone sensitive oligometastatic prostate cancer.

Complexity Level: 2

Eligibility: (1) Male, aged 18 years or older, (2) Histologically-proven oligometstatic adenocarcinoma of the prostate and no evidence of small cell cancer, (3) Stage: IV (newly diagnosed at presentation or relapse after curative intent therapy); M1 disease with 12 months & 36 mo. max duration; recurrent/metstatic disease previously treated with systemic or radiation therapy; Castration resistant prostate cancer (per PCWG3); Untreated pelvic lymph nodes as only site of disease; inability to treat all sites of disease with LAT; parenchymal brain mets.

Objectives: Primary objective: To compare failure free survival between patients with oligometastatic HSPC treated with standard systemic therapy plus ablative therapy to untreated prostate primary in patients with low volume metastatic disease burden versus standard systemic therapy plus local ablative therapy to all sites of disease. Secondary objectives: Radiographic Progression Free Survival; Incidence of new metastases as first event; Overall survival; Ablative treatment related adverse events (grade 3 or greater); Quality of Life (QOL); Economic analysis. Tertiary objectives: Correlative exploratory studies such as immunophenotyping to understand mechanisms of resistance to SBRT when added to standard systemic therapy and identify predictive/prognostic markers in the trial population, and to create a biorepository of tissue and blood for future correlative studies.

NCT Registration ID (from clinicaltrials.gov): NCT03784755
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: CCTG Led Trial
Status: Open to Accrual
Activation Date: April 18, 2019

Chair: (Canada) Dr. M. Tamim Niazi, The Jewish General Hospital, (514) 340-8288, (Canada) Dr. Patrick C.F. Cheung, Odette Cancer Centre, (416) 480-6165


Open to Accrual
REC3 (SWOG S1500)A Randomized, Phase II Efficacy Assessment of Multiple MET Kinase Inhibitors (Cabozantinib [NSC #761968], Crizotinib [NSC #749005],Savolitinib [NSC #785348], and Sunitinib [NSC #736511]) in Metastatic Papillary Renal Carcinoma (PAPMET)
A Study testing Four Drugs (Cabozantinib, Crizotinib, Savolitinib, and Sunitinib) and their Effects on Advanced Kidney Cancer

Complexity Level: 2

Eligibility: Patients must have histologically or cytologically confirmed papillary renal cell carcinoma which is metastatic or locally advanced disease not amenable to surgical resection. They must also have measurable disease (RECIST), they may have received prior therapy (up to one prior systemic therapy for advanced or metastatic renal cell carcinoma or prior radiation therapy), have a Zubrod PS of 0-1, have adequate hematologic and hepatic function, and be 18 years of age or older. Patients must have tissue available and be willing to submit for central pathologic review.

Objectives: Primary Objective: To compare progression-free survival (PFS) in patients with mPRCC treated with sunitinib to PFS in patients with mPRCC treated with MET kinase inhibitors. Secondary Objectives: a. To compare RECIST response rate (RR; defined as the combined rate of confirmed and unconfirmed PR and confirmed and unconfirmed CR) in patients with mPRCC treated with sunitinib to RR in patients treated with putative MET inhibitors. b. To compare overall survival (OS) in patients with mPRCC treated with sunitinib to OS in patients with mPRCC treated with putative MET inhibitors. c. To compare the safety profile of sunitinib and putative MET inhibitors in patients with mPRCC. Translational Objectives: To evaluate the prognostic and predictive value of MET mutations, MET copy number or other markers of MET signaling in patients with mPRCC treated with putative MET inhibitors

NCT Registration ID (from clinicaltrials.gov): NCT02761057
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Open to Accrual
Activation Date: July 27, 2016

Chair: (Canada) Dr. Daniel Heng, Tom Baker Cancer Centre, (403) 521-3166


Open to Accrual
REC4 (ECOG-ACRIN EA8143)A Phase 3 RandOmized Study Comparing PERioperative Nivolumab vs. Observation in Patients with Localized Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC)
A Study Comparing Surgery Alone to Surgery + Study Drug (Nivolumab) for Patients with Kidney Cancer

Complexity Level: 2

Eligibility: Patients with newly diagnosed higher risk RCC of any histology including sarcomatoid or unknown histology confirmed by biopsy for which radical or partial nephrectomay is planned. Patients must have no distant metastases, history of RCC within the past 5 years and have had no concurrent or prior systemic or local anti-cancer therapy for RCC. Paitents must be over the age of 18 and have no active or suspected autoimmune disease, no ongoing condition requireing systemic treatment with corticosteroids/other immunosuppressants and no history of severe hypersensitivity to a monoclonal antibody.

Objectives: Primary Objective: To compare recurrence-free survival (RFS) between patients with locally advanced renal cell carcinoma randomly assigned to perioperative nivolumab in conjunction with radical or partial nephrectomy with patients randomized to surgery alone. Secondary Objectives: To evaluate for differences in RFS associated with perioperative nivolumab compared to surgery alone among patients with clear cell histology. To compare the overall survival between the two arms. To describe the safety and tolerability of perioperative nivolumab.

NCT Registration ID (from clinicaltrials.gov): NCT03055013
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Open to Accrual
Activation Date: October 31, 2018

Chair: (Canada) Dr. Anil Kapoor, St. Joseph's Healthcare Charlton Campus, (905) 522-1155 Ext. 33218, (Canada) Dr. Daniel Heng, Tom Baker Cancer Centre, (403) 521-3166


Open to Accrual
I232A Phase II Study of Durvalumab (MEDI4736) With or Without Tremelimumab in Patients With Metastatic Castration Resistant Prostate Cancer


Complexity Level: 2

Eligibility: Patients with histologically confirmed adenocarcinoma of the prostate that is castrate resistant. Must have disease progression either PSA, objective or both as well as surgical or medical castration with testosterone levels <50mg/dL. An available tissue block from primary or metastatic tumour as well as accessible disease suitable for fresh biopsy and consent to biopsy prior to treatment is required. Patients must have measurable disease per RECIST 1.1. Patients may have received prior treatment with docetaxel chemotherapy, tyrosine kinase or other targeted agents. Failure/progression on abiraterone and/or enzalutamide is required. Antiandrogens must have been discontinued for < 4 weeks prior to study entry (6 weeks for bicalutamide). No prior immunotherapy or vaccines, treatment with oncolytics viruses is permissible. No prior history of immunodeficiency, or use or immunosuppressive agents within 28 days of randomization.

Objectives: Primary - To determine the objective response rate (RECIST 1.1 and irRECIST) in patients with metastatic castration resistant prostate cancer (mCRPC) treated with durvalumab alone or in combination with tremelimumab. Secondary - To determine the prostate-specific antigen (PSA) response rate as time to PSA progression; To evaluate time to objective disease progression; To evaluate the toxicity and tolerability of durvalumab alone or in combination with tremelimumab. Exploratory - To explore the utility of tissue and blood based biomarkers to select patients for treatment with durvalumab alone or in combination with tremelimumab.

NCT Registration ID (from clinicaltrials.gov): NCT02788773
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: CCTG Led Trial
Status: On Hold
Activation Date: August 18, 2016

Chair: (Canada) Dr. Eric W. Winquist, London Regional Cancer Program, (519) 685-8261, (Canada) Dr. Sebastien Hotte, Juravinski Cancer Centre at Hamilton Health Sciences, (905) 387-9495 Ext. 64605


On Hold
I234AA Phase II Study of AZD1775, A WEE1 Inhibitor, in Patients with Metastatic Castration-Resistant Prostate Cancer - A Sub-Study of IND.234
The purpose of this study is to find out what effects a new drug, AZD1775, has on prostate cancer and will look at the side effects of treatment with AZD1775. The researchers doing this study are also interested in looking for markers that may help predict which patients are most likely to be helped by AZD1775 and to see how the cancer cells respond to AZD1775.

Complexity Level: 1

Eligibility: Patients must meet the following criteria in addition to the eligiblity criteria outlined in IND.234. Patients without history of hypersensitivity to AZD1775 or any of its excipients or who have not received treatment with drugs with a similar mechanism of action. Patients witout any factors that increase the risk of QTc prolongation or risk of arrhythmic events or mean resting corrected QT interval (QTc) <= 470 msec. Patients on drugs with a narrow therapeutic index which are substrates of BRCP, PGP, CYP2C19 or CYP1A2, inhibitors of PGP, and which cannot be discontinued or changed to alternative drugs are not eligible.

Objectives: To determine the effect of AZD1775 on PSA decline and time to PSA progression. To determine objective response as determined by RECIST 1.1 criteria. To evaluate the safety and toxicity profile of AZD1775 in mCRPC patients. Tertiary Objectives To obtain cfDNA and non-malignant DNA from peripheral blood clinically annotated with patient disease characteristics and follow-up data to identify potential predictive and prognostic factors and relationship between cfDNA results with clinical presentation.

NCT Registration ID (from clinicaltrials.gov): NCT03385655
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: CCTG Led Trial
Status: On Hold
Activation Date: December 12, 2017

Chair: (Canada) Dr. Michael Kolinsky, Cross Cancer Institute, (780) 432-8762


On Hold
BL12A Multicentre Randomized Phase II Trial Comparing Nab-Paclitaxel to Paclitaxel in Patients with Advanced Urothelial Cancer Progressing on or after a Platinum Containing Regimen
The purpose of this study is to compare the effects of nab-paclitaxel to paclitaxel to treat this disease. This research is being done because currently there is no effective treatment for urothelial cancer that has progressed after prior chemotherapy.

Complexity Level: 2

Eligibility: Patients enrolled in this study must have histologically or cytologically confirmed diagnosis of transitional cell carcinoma of the urinary tract (bladder, urethra, ureter, renal pelvis) and metastatic or locally advanced inoperable disease extent (T4, N2, N3 or M1 disease).

Objectives: Primary Objective: progression free survival (PFS) Secondary Objectives: objective response rates (ORR), clinical benefit rate (CBR), time to response and response duration, safety, QOL, and health analysis Exploratory Objectives: Correlative Biology, Health and Demographic Assessment

NCT Registration ID (from clinicaltrials.gov): NCT02033993
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Closed to Accrual
Activation Date: January 27, 2014 Closing Date: April 06, 2017

Chair: (Canada) Dr. Srikala Sridhar, University Health Network, (416) 946-4501 Ext. 2520


Closed to Accrual
BLC1 (SWOG S1011)A Phase III Surgical Trial to Evaluate the Benefit of a Standard versus an Extended Pelvic Lymphadenectomy Performed at the Time Of Radical Cystectomy For Muscle Invasive Urothelial Cancer
This randomized phase III trial is studying standard pelvic lymphadenectomy to see how well it works compared to extended pelvic lymphadenectomy in treating patients undergoing surgery for invasive bladder cancer.

Complexity Level: 2

Eligibility: Patients must have histologically-proven (T2, T3, or T4a) urothelial carcinoma of the bladder (UCB) that requires primary radical cystectomy for definitive treatment.

Objectives: Primary: To compare disease-free survival (DFS) in eligible patients treated with radical cystectomy and extended pelvic lymph node dissection (PLND) compared to radical cystectomy and standard pelvic lymphadenectomy. Secondary: To compare overall survival (OS) between extended PLND versus standard pelvic lymphadenectomy. To evaluate operative time, whether nerve sparing was performed, morbidity and mortality, length of hospital stay, histology, lymph node counts density, adjuvant chemotherapy, and local and retroperitoneal soft tissue recurrence. Proximal extent of node dissection in those patients randomized to extended PLND will be evaluated as well. Translational Medicine Objectives: a. To bank paraffin embedded blocks or slides of the primary tumor, b. To determine the prognostic value of putative markers of the premetastatic niche, c. To evaluate if the prevalence of pre-metastatic niche is different between patients that received neoadjuvant chemotherapy and those who did not.

NCT Registration ID (from clinicaltrials.gov): NCT01224665
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: January 15, 2014 Closing Date: February 15, 2017

Chair: (Canada) Dr. Wassim Kassouf, The Research Institute of the McGill University, (514) 934-8246


Closed to Accrual
PR13 (MRC PR10)RADICALS: Radiotherapy and Androgen Deprivation In Combination After Local Surgery.
The standard of care for patients with prostate cancer is to undergo surgery to remove the prostate. Some patients then go on to receive radiation therapy and hormone therapy in an effort to stop the cancer from returning in a more aggressive form. It is unknown whether it is best to receive radiotherapy immediately after surgery or only when there is evidence (via blood tests) that the cancer has returned. Similarly, following radiotherapy, it is unknown how long horomone therapy should be given to patients, or even if it should be given at all. This trial involves multiple randomizations and is designed to answer these very important questions.

Complexity Level: 2

Eligibility: Men who have undergone radical prostatectomy for prostateic adenocarcinoma within 3 months. RT Timing Randomization: Post-opterative serum PSA less than 0.4 ng/mL. Uncertainty in the opinon of the physician and patient regarding the need for immediate post-operative RT. Hormone Duration Randomization: Post-opterative serum PSA less than 10 ng/mL. Patient is due to receive post-operative RT either adjuvant or salvage.

Objectives: Disease free survival; Freedom from treatment failure; Clinical progression-free survival; Overall survival; Non-protocol hormone therapy Quality of life; Treatment toxicity

NCT Registration ID (from clinicaltrials.gov): NCT00541047
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: September 27, 2007 Closing Date: December 30, 2016

Chair: (Canada) Dr. Charles Catton, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-4501 Ext. 2121, (Canada) Dr. Fred Saad, CHUM-Centre Hospitalier de l'Universite de Montreal, (514) 890-8000 Ext. 27466


Closed to Accrual
PR17 (ANZUP 1304)Randomised Phase III Trial of Enzalutamide in First Line Androgen Deprivation Therapy for Metastatic Prostate Cancer: ENZAMET
The purpose of this study is to determine the effectivetness of enzalutamide (a more potent and effective androgen receptor blocker), compared to conventional non-steroidal anti-androgen (NSAA: bicalutamide, nilutamide, or flutamide), when combined with a luteinising hormone releasing hormone analogue (LHRHA) or surgical castration, as first line androgen deprivation therapy (ADT) for metastatic prostate cancer. You may be eligible for this trial if you aged 18 years or above and have prostate cancer that has spread beyond your prostate but are otherwise in relatively good health. Participants in this trial will be randomly (by chance) allocated to one of two groups. Participants randomised to Group 1 will receive Enzalutamide daily, and patients randomised to Group 2 will receive Conventional NSAA. Both treatments are taken by mouth and will continue until your disease worsens or if you have side effects. Both groups will also be treated with a LHRHA or surgical castration.

Complexity Level: 2

Eligibility: Men starting first line androgen deprivation therapy for metastatic adenocarcinoma of the prostate. Key eligibility criteria include metastatic prostate cancer, adequate organ function and ECOG performance status 0-2.

Objectives: Primary endpoint: Overall survival

NCT Registration ID (from clinicaltrials.gov): NCT02446405
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: February 02, 2015 Closing Date: March 24, 2017

Chair: (Canada) Dr. Scott North, Cross Cancer Institute, (780) 432-8762


Closed to Accrual
PRC3 (CALGB C90203)A Randomized Phase III Study of Neo-Adjuvant Docetaxel and Androgen Deprivation Prior to Radical Prostatectomy Versus Immediate Radical Prostatectomy in Patients with High-Risk, Clinically Localized Prostate Cancer.
The purpose of this study is to compare the effects (good and bad) of the combination of chemotherapy and hormone therapy followed by radical prostatectomy (surgery to remove the prostate) with radical prostatectomy alone in patients with high risk prostate cancer to see which is better. Men who have prostate cancer that meets certain criteria are called "high risk" which means that there is a good chance that their prostate cancer will come back even after their prostate is removed. It is believed that a certain combination of drugs (docetaxel and LHRH agonists) that are usually used to treat advanced prostate cancer, will actually be beneficial if used before the prostate is removed, and before the cancer has the chance to grow into a more aggressive and problematic disease.

Complexity Level: 2

Eligibility: Patients with High-Risk, Clinically Localized Prostate Cancer.

Objectives: PSA Free Survival 3 Years Post Op; Compare 5-year bPFS, Disease Progresssion; Disease Free Survival and Overall Survival; Difference in Pathologic Stage; Safety and Tolerability; Correlative Studies: Diet and lifestyle; Frozen Tissue and Paraffin Blocks for Biomarker Analyses, Expression Profiling, chromosomal Gain or Loss Analysis

NCT Registration ID (from clinicaltrials.gov): NCT00430183
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: October 15, 2007 Closing Date: October 02, 2015

Chair: (Canada) Dr. Martin E. Gleave, Clinical Research Unit at Vancouver Coastal, (604) 875-4111


Closed to Accrual
PRC4 (ALLIANCE A031201)Phase III Trial of Enzalutamide (NSC#766085) Versus Enzalutamide, Abiraterone and Prednisone for Castration Resistant Metastatic Prostate Cancer
This randomized phase III trial studies enzalutamide to see how well it works compared to enzalutamide, abiraterone acetate, and prednisone in treating patients with castration-resistant metastatic prostate cancer. Androgens can cause the growth of prostate cancer cells. Drugs, such as enzalutamide, abiraterone acetate, and prednisone, may lessen the amount of androgens made by the body.

Complexity Level: 2

Eligibility: Progressive castration-resistant metastatic prostate cancer with histologically or cytologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features.

Objectives: To compare the overall survival of patients with progressive metastatic castration-resistant prostate cancer treated with either enzalutamide only or enzalutamide with abiraterone and prednisone. To assess the toxicity profile and compare safety by treatment arm, to assess and compare post-treatment PSA declines by treatment arm, to compare radiographic progression free survival and objective response rate by treatment arm, to test for radiographic progression free survival treatment interaction in predicting overall survival, to assess pre- and post-treatment measures of tumor burden and bone activity using PET/CT and bone scintigraphy and correlate these measures with overall survival, and to develop and validate prognostic and predictive models of overall survival.

NCT Registration ID (from clinicaltrials.gov): NCT01949337
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: October 27, 2014 Closing Date: August 31, 2016

Chair: (Canada) Dr. Kim Chi, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2746


Closed to Accrual
REC2 (ECOG E2805)ASSURE: Adjuvant Sorafenib or Sunitinib for Unfavorable Renal Carcinoma
Most patients with cancer usually have surgery to remove the tumour and then must undergo chemotherapy in an effort to stop the cancer from coming back in a more aggressive form (called recurrence). For kidney cancer patients who are at a high risk for recurrence, it is not yet known which drugs work best to prevent recurrence. Therefore the purpose of this study is to determine if either the drug Sunitinib or the drug Sorafenib might be beneficial to patients who have recently undergone surgery to remove their kidney cancer. This trial is designed in a double blind fashion, meaning that patients will not know which treatment they are receiving. One third will receive sunitinib, one third will receive sorafenib, and one third will receive a placebo (a substance that does not do anything).

Complexity Level: 2

Eligibility: Patients with primary-intact renal cell carcinoma, eligible for nephrectomy with curative intent.

Objectives: Primary: To demonstrate an improvement in disease-free survival in locally advanced renal cell carcinoma patients receiving Sunitinib vs Sorafenib vs placebo after radical or partial nephrectomy. Secondary: To compare overall survival of patients randomized to each of the two regimens with placebo, to further define toxicity of prolonged administration of study agents and to collect biological specimens to assess their characteristics and associations.

NCT Registration ID (from clinicaltrials.gov): NCT00326898
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Closed to Accrual
Activation Date: September 14, 2006 Closing Date: September 02, 2010

Chair: (Canada) Dr. Lori Wood, QEII Health Sciences Centre, (902) 473-6106, (Canada) Dr. Michael A.S. Jewett, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-2909


Closed to Accrual
BL1A Clinical Trial on the Effects of Adjuvant Chemotherapy on Two Different Contemporary Treatments for Infiltrating Bladder Cancer


NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: April 20, 1979 Closing Date: September 01, 1980

Permanently Closed
BL10 (4B951)MVAC in Organ-Confined Bladder Cancer Based on p53 Status.
The purpose of this study is to evaluate the effects (good or bad) of treament with M-VAC in patients who have had their bladder cancer removed by surgery. The usual treatment after surgery is close observation without additional therapy.

Eligibility: Patients who have undergone a radical cystectomy and bilateral pelvic lymphadenectomy

Objectives: To compare the recurrence free and overall survival of those patients with alterations in the p53 gene who are treated with MVAC to patients with tumours demonstrating p53 alterations who are observed. To compare the recurrence free and overall survival prospectively of patients with tumours demonstrating alterations in p53 who are observed to patients with no p53 alterations who are also observed. To examine the expression of p53 and other genes, particularly RB, p21 and p16 involved in cell cycle regulation that may be involved in the response to chemotherapy. To study the association of p53 mutational gene status with p53 proteinexpression by IHC, outcome (recurrence-free and overall survival).

NCT Registration ID (from clinicaltrials.gov): NCT00005047
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: December 22, 2003 Closing Date: March 28, 2006

Chair: (Canada) Dr. Laurence Klotz, Odette Cancer Centre, (416) 480-4673


Permanently Closed
BL11A Phase III Study of Iressa? in Combination with Intravesical BCG versus Intravesical BCG Alone in High Risk Superficial Transitional Cell Carcinoma of the Bladder
The purpose of this study is to compare the effects on you and your superficial bladder cancer of a new drug Iressa? given with another commonly-used treatment to treat this disease. This research is being done because superficial bladder cancer often comes back after surgery. Iressa? has been shown to shrink cancer in animals. It is not clear, however, if it can offer better results when it is given together with intravesical BCG (BCG vaccine that is put into the bladder) compared to BCG put into the bladder alone. The combination of BCG put into the bladder and Iressa? has not been studied before.

Eligibility: Patients with high risk Ta, Tis or T1 superficial bladder cancer, who completed transurethral resection of all visible bladder lesions within 21 to 60 days prior to randomization, and without other evidence of metastasis.

Objectives: Comparisons of time to treatment failure, complete response rate for patients with carcinoma in situ (Tis) at randomization, time to recurrence, time to progression, overall survival, adverse event and safety, and quality of life. Evaluate prognostic significance of tumour marker expression on the primary tumour and impact of therapy on tumour marker expression.

NCT Registration ID (from clinicaltrials.gov): NCT00352079
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: April 12, 2006 Closing Date: December 04, 2008

Chair: (Canada) Dr. Louis Lacombe, CHUQ - Hotel Dieu de Quebec, (418) 691-5O50


Permanently Closed
BL2The Prophylactic Use of Intravesical Mitomycin C in Recurrent Superficial Bladder Cancer


NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: November 18, 1981 Closing Date: October 15, 1982

Permanently Closed
BL3NCIC Trial of Pre-Operative (or Radical) Radiotherapy With Randomized Addition of Concurrent Cisplatin for Locally Advanced Transitional Cell Carcinoma of the Bladder


NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: May 03, 1985 Closing Date: April 19, 1989

Permanently Closed
BL4 (E5886)A Phase III Trial of Cisplan Alone or in Combination with Doxorubicin, Vinblastine and Methotrexate in Advanced Bladder Cancer


NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: October 30, 1986 Closing Date: May 15, 1989

Permanently Closed
BL5 (BA06)A Phase III Study of Primary Chemotherapy in Locally Advanced Transitional Cell Carcinoma of the Bladder


NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: March 02, 1990 Closing Date: June 01, 1995

Chair: (Canada) Dr. Mary Gospodarowicz, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-4501 Ext. 4421


Permanently Closed
BL7 (30987)Randomized Phase III Study Comparing Paclitaxel/Cisplatin/Gemcitabine and Cisplatin/Gemcitabine in Patients with Metastatic or Locally Advanced Urothelial Cancer without Prior Systemic Therapy
The purpose of this study is to compare the effects (good and bad) on patients with this type of urothelial cancer of a drug called Paclitaxel in addition to standard treatment (Gemcitabine and Cisplatin), to the standard treatment alone to see which is better.

Eligibility: Patients with locally advanced and/or metastatic cell carcinoma of the urothelium who have not had prior systemic therapy. Patients must have histologically proven stage IV locally advanced disease (T4b, N0-N1) or metastatic ((N2N3 or M10 transitional cell carcinoma of the urothelium (pure or mixed) including bladder, urethra, ureter and renal pelvis. Patients should not be suitable for surgery or radiation with curative intent. However, patients whose pre-chemotherapy sites of disease are restricted to the primary or regional lymph node sites and who have had a major response to chemotherapy will be evaluated for post-chemotherapy surgical resection of residual cancer if the tumour has become resectable at the end of chemotherapy.

Objectives: The primary objective of this trial is to compare two treatment groups, cisplatin/ gemcitabine and cisplatin/ gemcitabine/ paclitaxel, with respect to the duration of survival. Secondary objectives are to compare in the two treatment groups the: 1) duration of progression-free survival 2) response rates (RECIST) 3)duration of response. Also to compare and characterize the nature of the toxicity experienced in each arm.

NCT Registration ID (from clinicaltrials.gov): NCT00022191
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: December 11, 2001 Closing Date: June 01, 2004

Chair: (Canada) Dr. Eric W. Winquist, London Regional Cancer Program, (519) 685-8261


Permanently Closed
BL8 (30994)Randomized Phase III Trial Comparing Immediate Versus Deferred Chemotherapy After Radical Cystectomy in Patients with pT3-pT4, and/or N+M0 Transitional Cell Carcinoma (TCC) of the Bladder.
The purpose of this study is to compare the effects (good and bad) of giving chemotherapy soon after surgery (within 90 days) to delaying chemotherapy until cancer comes back to see which is better. Preliminary studies have suggested that chemotherapy may be helpful in delaying or preventing recurrence after removal of the bladder. However, other studies have also shown that late chemotherapy can be helpful in putting the cancer back into remission, and we are not yet sure which is the best strategy for treatment.

Complexity Level: 2

Eligibility: Patients with histologically proven transitional cell carcinoma (TCC) of the bladder (pT2 incidental pT3 or pT4) and/or node positive (pN1-3) M0 TCC following radical cystectomy and lymphadenectomy. Lymph node dissection of 15 or more lymph nodes is recommended. Patients must be able to start chemotherapy within 90 days after surgery.

Objectives: To compare the survival of patients with T3-T4 or N+ bladder cancer after radical cystectomy when treated with immediate adjuvant chemotherapy versus chemotherapy at relapse; to compare the progression-free survival.

NCT Registration ID (from clinicaltrials.gov): NCT00028756
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: December 11, 2001 Closing Date: May 09, 2008

Chair: (Canada) Dr. Fred Saad, CHUM-Centre Hospitalier de l'Universite de Montreal, (514) 890-8000 Ext. 27466, (Canada) Dr. Lori Wood, QEII Health Sciences Centre, (902) 473-6106


Permanently Closed
I111A Randomized Phase II Study of CGP 64128A (ISIS 3521) and CGP 69846A (ISIS 5132) in Hormone Refractory Prostate Cancer


NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: February 12, 1998 Closing Date: January 22, 1999

Permanently Closed
I119A Phase II Study of Troxacitabine in Patients With Advanced and/or Metastatic Renal Cell Carcinoma


NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: June 16, 1999 Closing Date: March 21, 2000

Permanently Closed
I128NCIC CTG Phase II Study of SCH66336 in Patients With Inoperable, Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelial Tract Who Have Received Prior Chemotherapy


NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: December 03, 1999 Closing Date: May 01, 2001

Chair: (Canada) Dr. Eric W. Winquist, London Regional Cancer Program, (519) 685-8261


Permanently Closed
I140A Randomized Phase II Study Of ZD1839 (Iressa) in Patients With Hormone Refractory Prostate Cancer
This research is being done because currently there is no effective treatment for this type of cancer. Both doses of Iressa? have shown some anticancer effect in early human studies. Therefore we want to know which dose will be effective with the fewest side effects.

Eligibility: Prostate cancer patients with evidence of progression by rising PSA or progressive measurable disease on androgen ablative therapy; PSA > 20 ng/mL; chemo-naive; minimally symptomatic disease.

Objectives: To determine the efficacy, and toxicity of two different doses of ZD1839 (250 mg or 500 mg) in patients with hormone refractory prostate cancer. Objective response where applicable, PSA response and duration of these responses, will be measured.

NCT Registration ID (from clinicaltrials.gov): NCT00025116
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: April 24, 2001 Closing Date: April 25, 2002

Permanently Closed
I143A Phase II Study Of MG98 Given as a 2-Hour Twice Weekly Infusion in Patients With Advanced and/or Metastatic Renal Cell Carcinoma


Eligibility: Patients with recurrent or metastatic renal cell carcinoma. No prior chemotherapy or immunotherapy for advanced/recurrent disease. Clinically and/or radiologically documented unidimensionally measurable disease.

Objectives: To evaluate the efficacy and safety of MG98 when given as a 2-hour IV infusion twice weekly for 3 out or every 4 weeks in patients with advanced and/or metastatic renal cell carcinoma.

NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: May 01, 2001 Closing Date: May 10, 2002

Chair: (Canada) Dr. Eric W. Winquist, London Regional Cancer Program, (519) 685-8261


Permanently Closed
I153A Phase I Study of Combination Neoadjuvant Hormone Therapy and Weekly OGX-011 (Clusterin Antisense Oligonucleotide) Prior to Radical Prostatectomy in Patients With Localized Prostate Cancer
Patients who have been diagnosed with adenocarcinoma of the prostate, meet all of the eligibility requirements and are potential candidates for radical prostatectomy will receive OGX-011 will be administered intravenously over 2 hours on days 1, 3, 5, 8, 15, 22, 29. Patients will also be given buserelin day one and daily oral flutamide for the 29 days. Radical prostatectomy surgery will be scheduled within 7 days after the last dose of OGX-011.

Eligibility: Histologically confirmed adenocarcinoma of the prostate. No prior treatment. Must be a potential candidate for radical prostatectomy. Minimum 2 positive biopsies and at least one of the following: clinical stage T3; serum PSA > 10 ng/ml; Gleason score 7-10 or Gleason score 6 and >= 3 positive biopsies

Objectives: To determine the toxicity and define the recommended phase II dose of OGX-011 administered days 1, 3, 5, 8, 15, 22 and 29 intravenously with neoadjuvant hormone therapy prior to radical prostatectomy. To determine the plasma pharmacokinetic profile To determine the tissue concentration of OGX-011 in radical prostatectomy specimens. To measure evidence of effect on clusterin expression in peripheral blood mononuclear cells and clusterin serum levels. To assess the effect of the combined hormone and OGX-011 therapy on com[plete response rates. To attempt to establish correlations between palsma and or prostate concentrations of OGX-011 with patient response or toxicity.

NCT Registration ID (from clinicaltrials.gov): NCT00054106
Participation: Limited to one centre: BCCA-Vancouver
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: December 06, 2002 Closing Date: May 05, 2004

Chair: (Canada) Dr. Kim Chi, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2746


Permanently Closed
I161A Phase II Study of Triapine (NSC 663249) in Previously Untreated Patients With Recurrent Renal Cell Carcinoma


Eligibility: Patients with histologically or cytologically documented renal cell cancer that is locally recurrent or metastatic. Clinically and/or radiologically documented disease. Unidimensionally measurable disease. No prior systemic chemotherapy regimens. Previous interferon permitted > 3 months prior to study entry. No immunotherapy for advanced/recurrent disease. No gene therapy. Known HIV-positive patients are not permitted nor patients with known glucose-6 phosphate dehydrogenase deficiency.

Objectives: To assess the efficacy (objective response rate) of Triapine given as a 2-hour IV infusion for 4 consecutive days every other week to patients with recurrent/ metastatic renal cell cancer who have received no prior systemic therapy for recurrence. To determine adverse events and tolerability of Triapine in this patient population. To describe time to disease progression and overall patient survival.

NCT Registration ID (from clinicaltrials.gov): NCT00075660
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: January 16, 2004 Closing Date: April 05, 2005

Chair: (Canada) Dr. Jennifer Knox, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-2399


Permanently Closed
I165A Randomized Phase II Study Of OGX-011 In Combination With Docetaxel And Prednisone Or Docetaxel And Prednisone Alone In Patients With Metastatic Hormone Refractory Prostate Cancer.
A phase II study for patients with advanced prostate cancer who have become hormone refractory following previous treatment. Patients will be randomized (50-50 chance) to receive either Arm A (OGX-011, docetaxel and prednisone) or Arm B (docetaxel and prednisone). Patients will receive treatment for up to 10 cycles (approx. 30 weeks) as long as their disease does not get worse, they do not have serious side effects and they wish to continue.

Eligibility: Histologically or cytologically diagnosed prostate cancer with documented evidence of progression by rising PSA (>5 ng/mL at baseline). Patients must have metastatic or locally recurrent disease for which no curative therapy exists and for which systemic chemotherapy is indicated due to progression while receiving androgen ablative therapy. No prior chemotherapy except estramustine. Prior hormone therapy permitted but must be refractory and discontinued > 4 weeks (6 wks for bicalutamide). Prior radiation permitted if > 4 weeks. ECOG 0, 1, 2. Adequate organ function. No pre-existing neuropathy >= grade 2 or therapeutic anti-coagulation.

Objectives: To determine the efficacy, as measured by PSA response and duration of response, of weekly OGX-011 administered intravenously in combination with q 3 weekly docetaxel and prednisone, or docetaxel and prednisone in patients with HRPC. To determine objective response and duration in those with measurable disease at baseline. To determine tolerability and toxicity when given in this schedule. To measure evidence of OGX-011 and docetaxel or docetaxel effect on serum clusterin levels. To describe time to progression and overall patient survival for both cohorts.

NCT Registration ID (from clinicaltrials.gov): NCT00258388
Participation: Limited to selected centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: June 27, 2005 Closing Date: December 21, 2006

Chair: (Canada) Dr. Kim Chi, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2746


Permanently Closed
I167Phase II Study of BAY 43-9006 (NSC 724772) in Patients With Hormone Refractory Prostate Cancer
The main purpose of this study is to find out what effects an experimental drug called BAY43-9006 has on patients with prostate cancer which has stopped responding to hormone therapy, and to find out the side effects (good or bad) the drug causes. As well, researchers will look at tumour tissue samples (from a sample of the tumour that was removed at the time of the initial diagnosis) to find out what effects BAY43-9006 has on individual cancer cells. Patients who meet all of the eligibility criteria will be given a supply of BAY43-9006 pills to take one every day. Treatment will be repeated every 4 weeks.

Eligibility: Patients with histologically or cytologically diagnosed prostate cancer that is advanced and non-curable with standard therapy. PSA progression with PSA>10 ng/mL at study entry. Primary tumour available for immunohistochemistry. No prior chemotherapy. Minimally symptomatic disease.

Objectives: To determine PSA response rate. To determine objective response rate and duration of response as measured by RECIST. To determine the tolerability and toxicity of BAY 43-9006 given to this patient population. To describe time to treatment failure and overall patient survival. To correlate the relationship between tumour markers and patients with response and with non-progression.

NCT Registration ID (from clinicaltrials.gov): NCT00093457
Participation: Limited to invited centres only.
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: June 21, 2004 Closing Date: December 20, 2005

Chair: (Canada) Dr. Kim Chi, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2746


Permanently Closed
I195A Phase II Study of SB939 in Patients with Recurrent or Metastatic Castration Resistant Prostate Cancer
The main purpose of this study is to find out how effective the experimental drug SB939 is in treating prostate cancer. In addition, this study will look at the side effects of SB939. Treatment will be SB939 once daily by mouth 3 times a week (every other day) for the first three weeks and then one week off. Researchers will also look at cancer cell markers from the patient's tissue sample as well as SB939 levels in Circulating Tumour Cells.

Complexity Level: 2

Eligibility: Patients with a histological diagnosis of metastatic and/or locally recurrent castration resistant adenocarcinoma of the prostate. Patients must be hormone refractory and have discontinued anti-androgens for at least 4 weeks prior to study entry. PSA >= 5 ng/mL at study entry. Up to 1 prior chemotherapy regimen is permitted. ECOG 0 or 1. Adequate cardiac function and acceptable end-organ function.

Objectives: 1.1 The primary objective of this study is to determine the efficacy (as measured by PSA response and progression free survival) of SB939 when given orally every other day 3 times a week, in patients with castration resistant prostate cancer, who have received 0-1 prior chemotherapy regimens. 1.2 To determine objective response and response duration in patients with measurable disease at baseline. 1.3 To determine the tolerability and toxicity of SB939 in this population. 1.4 Enumeration of Circulating Tumour Cells (CTC) at baseline and after 6 weeks (and 12 weeks if patient is still on study treatment) using two methodologies. 1.5 To explore potential molecular factors predictive of response by assessment of archival prostate tumour tissue. 1.6 To explore the utility of ERG and PTEN expression on circulating tumour cells as a potential prognostic and predictive marker for response to SB939. 1.7 To describe time to PSA and time to objective progression in patients treated with SB939.

NCT Registration ID (from clinicaltrials.gov): NCT01075308
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: February 10, 2010 Closing Date: November 04, 2011

Chair: (Canada) Dr. Bernhard Eigl, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2707, (Canada) Dr. Kim Chi, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2746


Permanently Closed
I205A Phase II Study of PX-866 in Patients With Recurrent or Metastatic Castration Resistant Prostate Cancer (CRPC).


Complexity Level: 2

Eligibility: Androgen ablation must include either medical or surgical castration. If the patient is receiving medical androgen ablation, a castrate level of testosterone (< 1.7 nmol/L) must be present. Patients must have metastatic or locally recurrent disease, for which no curative therapy exists and for which systemic therapy is indicated due to progression following castration. Either:PSA Progression: A rising PSA, while receiving androgen ablative therapy, with 2 subsequent rises over a reference value (not necessarily consecutively), measured a minimum of one week apart. The PSA that confirms progression must have a value of >= 5 ng/ml and must be performed no longer than 7 days prior to trial registration.OR Radiological Progression. The PSA must be >=5 ng/ml at the time of study entry. ECOG performance of 0, 1 or 2; Age > 18 years of age. All patients must have formalin fixed paraffin embedded tissue. Presence of clinically and/or radiologically documented disease.

Objectives: To determine the efficacy of PX-866 when given orally daily in patients with castration resistant prostate cancer, who have received no prior chemotherapy regimens for recurrent disease.To determine the tolerability and toxicity. of PX-866 in this population. To investigate additional potential measures of efficacy including: PSA response rate, Objective response rate, Change in circulating tumour cell number during treatment. To explore potential molecular factors predictive of response by assessment of archival prostate tumour tissue and baseline circulating tumour cells. In selected participating centres, to determine evidence of effect on PI3K activation pre- and post administration of PX-866 in platelets

NCT Registration ID (from clinicaltrials.gov): NCT01331083
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: April 04, 2011 Closing Date: January 10, 2014

Chair: (Canada) Dr. Kim Chi, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2746, (Canada) Dr. Sebastien Hotte, Juravinski Cancer Centre at Hamilton Health Sciences, (905) 387-9495 Ext. 64605


Permanently Closed
I209A Randomized Phase II Study of Reolysin in Combination With Docetaxel and Prednisone or Docetaxel and Prednisone Alone in Patients With Metastatic Castration Resistant Prostate Cancer
The main purpose of this study is to discover if adding reolysin to standard chemotherapy (docetaxel/prednisone) is as effective as standard chemotherapy (docetaxel/prednisone) alone by looking at changes in PSA levels, CTCs and amount of disease. On both arms the docetaxel will be given by intravenous injection over 1 hr day 1 every three weeks and prednisone will be taken by mouth twice a day for 21 days. On the experimental arm, Reolysin will be given by intravenous injection over 1 hr on days 1-5 every three weeks, after the docetaxel infusion. Side-effects and safety of reolysin and docetaxel in combination will be monitored. Additional research will investigate tissue samples from previously removed prostate tissue.

Complexity Level: 2

Eligibility: Patients with a histological diagnosis of metastatic and/or locally recurrent castration resistant adenocarcinoma of the prostate. Tumour block available. Patients must be hormone refractory and have discontinued anti-androgens for at least 4 weeks prior to study entry. PSA >= 5 ng/mL at study entry. No prior chemotherapy for recurrent/metastatic disease. No prior docetaxel unless given adjuvantly and >= 12 months prior to enrollment. ECOG 0, 1 or 2. Adequate end-organ function.

Objectives: 1. To evaluate efficacy which will be based on the lack of disease progression measured at 12 weeks. 2a. To determine the tolerability and toxicity of Reolysin and docetaxel when given in combination. 2b. To investigate additional potential measures of efficacy including CTC status, CTC conversion rate, change in PSA levels, Objective response rate and effect of both treatments on overall survival. 2c. Explore potential molecular factors predictive of response in archival tumour and baseline CTCs.

NCT Registration ID (from clinicaltrials.gov): NCT01619813
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: June 11, 2012 Closing Date: September 25, 2015

Chair: (Canada) Dr. Bernhard Eigl, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2707


Permanently Closed
I24NCIC CTG Phase II Study of Deoxycoformycin in Renal Cell


NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: September 06, 1985 Closing Date: November 26, 1986

Permanently Closed
I38NCIC CTG Phase II Study of TNF in Renal Cell


NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: June 01, 1988 Closing Date: September 01, 1989

Permanently Closed
I4NCIC CTG Phase II Study of Lonidamine in Hypernephroma


NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: April 01, 1982 Closing Date: May 05, 1984

Permanently Closed
I46NCIC CTG Phase II Study of LY186641 in Patients With Renal Cell Carcinoma


NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: October 25, 1989 Closing Date: May 11, 1990

Permanently Closed
I49NCIC CTG Phase II Study of Gemcitabine in Renal Cell Carcinoma


NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: March 19, 1990 Closing Date: November 30, 1990

Permanently Closed
I6NCIC CTG Phase II Study of Interferon in Renal Cell Cancer


NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: November 01, 1983 Closing Date: September 20, 1984

Permanently Closed
I70NCIC CTG Phase II Study of Taxotere in Patients With Metastatic Renal Cell Carcinoma


NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: August 24, 1992 Closing Date: February 03, 1993

Permanently Closed
I88A Phase I/II Study of 9-Cis-Retinoic Acid (LGD1057) and Interferon a-2b (INTRON A) in Patients With Recurrent or Metastatic Renal Cell Carcinoma


NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: August 03, 1995 Closing Date: April 29, 1997

Permanently Closed
I95NCIC CTG Phase II Study of Gemcitabine/Cisplatin in Patients With Inoperable, Locally Advanced or Metastatic Transitional Cell Carcinoma of the Urothelial Tract


NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: August 06, 1996 Closing Date: October 03, 1997

Permanently Closed
PR1Hormonal Therapy versus Radiotherapy for the Treatment of Clinical Stage C and D Carcinoma of the Prostate


NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: April 01, 1979 Closing Date: May 26, 1981

Permanently Closed
PR10 (Z0070)Randomized Trial of Radical Prostatectomy versus Brachytherapy for Patients With T1c or T2a N0 M0 Prostate Cancer


Eligibility: Patients must have a PSA of < 10 ng/ml. Patients must have histologically proven clinical stage T1c (usually impalpable) or T2a (unilaterally abnormality, papable or visible on TRUS), N0, M0 adenocarcinoma of the prostate, diagnosed within 120 days prior to registration on this study. Note: bilateral palpable disease is not allowed.

Objectives: To ascertain whether patients assigned to receive brachytherapy have equal or better overall survival as compared to patients randomized to receive radical prostatectomy. To compare the two treatment arms with respect to: metastasis-free survival, the probability of survival without symptoms, side effects from the intervention and Quality of Life addressed in the companion study.

NCT Registration ID (from clinicaltrials.gov): NCT00023686
Participation: Limited to centres with a current CPA/FWA #
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: February 19, 2002 Closing Date: April 09, 2004

Chair: (Canada) Dr. Neil Fleshner, University Health Network, (416) 946-4501 Ext. 2899


Permanently Closed
PR10C (Z0071)Health-Related Quality of Life in Patients With Low Risk, Localized Prostate Cancer Randomized to Radical Prostatectomy or Brachytherapy


Eligibility: Must be randomized to PR.10

Objectives: To obtain quality of life information.

NCT Registration ID (from clinicaltrials.gov): NCT00052481
Participation: Patients randomized to PR.10
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: September 19, 2003 Closing Date: April 09, 2004

Chair: (Canada) Dr. Neil Fleshner, University Health Network, (416) 946-4501 Ext. 2899


Permanently Closed
PR11A Phase III Study of Active Surveillance Therapy Against Radical Treatment in Patients Diagnosed with Favourable Risk Prostate Cancer (START)
This study examines whether or not men with newly diagnosed cancer of the prostate should immediately undergo surgery or radiation therapy as opposed to actively monitoring the disease and treating only if the cancer gets worse. It is believed that many men suffer the side effects of radical treatments, when their cancer in fact has a very small chance of ever causing any problems. Currently, there are excellent, non-invasive tools for accurately monitoring prostate cancer progression, which may potentially be used to determine when and if radical therapy is required. For more information, please view our Patient Educational Video at the following web link: http://www.ctg.queensu.ca/trials/start/start.html

Complexity Level: 2

Eligibility: Histologically confirmed adenocarcinoma of the prostate that is negative for metastasis. Patient is a suitable candidate for radical prostatectomy or radiotherapy. No previous treatment for prostate cancer for greater than 6 months. Patient has been classified as favourable risk as defined by the following: clinical stage T1b, T1c, T2a or T2b, surgical Gleason score <= 6, PSA <= 10.0 ng/ml. For more information, please view our Patient Educational Video at the following web link: http://smaug/trials/start/start.html

Objectives: To compare disease specific survival in patients with favourable risk prostate cancer treated with radical prostatectomy or radical radiotherapy at the time of initial diagnosis to active surveillance and selective intervention based on pre-specified biochemical, histological or clinical criteria.

NCT Registration ID (from clinicaltrials.gov): NCT00499174
Participation: Not limited
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: June 15, 2007 Closing Date: May 13, 2011

Chair: (USA) Dr. Adam S. Kibel, Washington University School of Medicine, (314) 362-8295, (Canada) Dr. Laurence Klotz, Odette Cancer Centre, (416) 480-4673


Permanently Closed
PR12Phase III Study of Neoadjuvant Docetaxel And Androgen Suppression Plus Radiation Therapy Versus Androgen Suppression Alone Plus Radiation Therapy For High-Risk Localized Adenocarcinoma Of The Prostate (DART)
This study looks at men with prostate cancer that are at high risk of the disease returning. The purpose of this study is to compare the effects, on prostate cancer, of a chemotherapy drug (Docetaxel) given with the standard treatment compared to the standard treatment alone. The standard treatment for this cancer is hormone therapy and local radiation therapy.

Eligibility: Patients with histologically proven, localized (NO, M0) adenocarcinoma of the prostate with adverse prognostic features which are considered to be high risk for recurrence based on the presence of at least one of the following features: T stage > or = to 3a, Gleason Score > or = 8 or presenting PSA>20

Objectives: The primary objective is to compare disease free survival rates in men treated with androgen suppression therapy and radiation therapy followed by androgen suppression therapy with or without neoadjuvant docetaxel. Secondary objectives include overall survival, degree of PSA suppression prior to radiation therapy and Quality of Life.

NCT Registration ID (from clinicaltrials.gov): NCT00651326
Participation: Open to member centres
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: March 03, 2008 Closing Date: November 12, 2009

Chair: (Canada) Dr. Kim Chi, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2746, (Canada) Dr. Michael McKenzie, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2380


Permanently Closed
PR15Randomized Phase II Feasibility Trial Of Image Guided External Beam Radiotherapy With Or Without High Dose Rate Brachytherapy Boost In Men With Intermediate-Risk Prostate Cancer
Feasibility study in intermediate risk prostate cancer radiotherapy treatments.

Complexity Level: 1

Eligibility: . Histologically confirmed CaP . PSA < 20 ng /ml . TNM classification . T2b to T2c, GS < 8/10 or . T1c-T2a GS 7/10 or . T1c-T2a, GS less than or equal to 6/10, 10 less than or equal to PSA < 20 . Prostate volume less than or equal to 75 cc

Objectives: Primary: The primary objective of this feasibility study is to assess the ability of Canadian investigators from multiple institutions to randomize patients to curative intent IGRT or IGRT with HDR brachytherapy boost. Secondary: Acute GU and GI adverse events; Quality assurance; Treatment compliance

NCT Registration ID (from clinicaltrials.gov): NCT01982786
Participation: Limited to invited centres
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: November 05, 2013 Closing Date: September 30, 2015

Chair: (Canada) Dr. Douglas Andrew Loblaw, Odette Cancer Centre, (416) 480-4806, (Canada) Dr. Gerard Morton, Odette Cancer Centre, (416) 480-6165, (Canada) Dr. Eric Vigneault, CHUQ - Hotel Dieu de Quebec, (418) 691-5264


Permanently Closed
PR2 (8794)Treatment of Pathologic Stage C Carcinoma of the Prostate With Adjuvant Radiotherapy


NCT Registration ID (from clinicaltrials.gov): no NCT
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: February 22, 1990 Closing Date: January 01, 1997

Chair: (Canada) Dr. Joseph Chin, London Health Sciences Centre, (519) 685-8451


Permanently Closed
PR3 (PR3)Intergroup Phase III Randomized Trial Comparing Total Androgen Blockade Versus Total Androgen Blockade Plus Pelvic Irradiation In Clinical Adenocarcinoma Of The Prostate
The purpose of this study is to determine which of the treatments is most effective in prolonging life and giving patients with this stage of prostate cancer the best possible quality of life.

Eligibility: Patients with adenocarcinoma of the prostate who have performance status of 0-2, adequate blood counts and liver and kidney function, and no contraindication to pelvic radiotherapy.

Objectives: To evaluate any benefit from the addition of radiation therapy to the treatment of the patients with cancer of the prostate who are receiving hormonal therapy in terms of overall survival, time to progression, symptomatic local control, and quality of life.

NCT Registration ID (from clinicaltrials.gov): NCT00002633
Participation: Limited to North America centres with current CPA/FWA#; all MRC - UK centres.
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: February 08, 1995 Closing Date: August 31, 2005

Chair: (USA) Dr. George Wilding, Univ. of WI Comprehensive Can Ctr., (608) 263-0209, (USA) Dr. Richard Whittington, Veteran's Hospital, (215) 823-5855, (USA) Dr. Srinivasan Vijayakumar, The University of Chicago Medical Center, (312) 791-2514, (Canada) Dr. Padraig Warde, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-4501 Ext. 2122


Permanently Closed
PR5 (PR5)A Randomized Trial of Shorter Radiation Fractionation Schedule for the Treatment of Localized Prostate Cancer


NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: February 14, 1995 Closing Date: September 15, 1998

Chair: (Canada) Dr. Mary Gospodarowicz, Univ. Health Network-OCI/Princess Margaret Hospital, (416) 946-4501 Ext. 4421, (Canada) Dr. William James Morris, BCCA - Vancouver Cancer Centre, (604) 877-6000 Ext. 2673


Permanently Closed
PR6Randomized Placebo-Controlled Trial of Mitoxantrone/Prednisone and Clodronate versus Mitoxantrone/Prednisone Alone in Patients with Hormone Refractory Metastatic Prostate Cancer and Pain


NCT Registration ID (from clinicaltrials.gov): NCT00003232
NCI US Affiliation: No
Clinical Trials Application (Canada): Yes
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: November 24, 1997 Closing Date: May 14, 2001

Permanently Closed
PR7 (PR7)A Phase III Randomized Trial Comparing Intermittent Versus Continuous Androgen Suppression for Patients With Prostate-Specific-Antigen Progression in the Clinical Absence of Distant Metastases Following Radiotherapy for Prostate Cancer
This research study will compare continuous hormone treatment to intermittent hormone treatment to determine if intermittent treatment is as effective and if it improves quality of life. At this time, no one knows which treatment may be better for me.

Complexity Level: 2

Eligibility: Patients who completed radiotherapy to the prostate more than a year ago and who have a rising PSA > 3 ng/ml and higher than the lowest level since the end of radiotherapy without other evidence of metastasis.

Objectives: Comparisons of overall survival, time to the development of hormone resistance, quality of life, serum cholesterol and HDL/LDL levels. Evaluate duration of treatment and non-treatment intervals, time to testosterone recovery and time to recovery of potency.

NCT Registration ID (from clinicaltrials.gov): NCT00003653
Participation: Limited to centres with current CPA #.
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: January 05, 1999 Closing Date: November 30, 2005

Chair: (USA) Dr. Celestia S. Higano, University of Washington, (206) 548-4518, (Canada) Dr. Juanita Crook, BCCA - Cancer Centre for the Southern Interior, (250) 712-3900 Ext. 3979, (Canada) Dr. Laurence Klotz, Odette Cancer Centre, (416) 480-4673, (USA) Dr. Eric Horwitz, Fox Chase Cancer Centre, (215) 728-2995, (UK) Dr. David Dearnaley, Royal Marsden Hospital, (20) 8661-3271


Permanently Closed
PR8 (SWOG S9346)Phase III Study of Intermittent Androgen Deprivation in Patients With Stage D2 Prostate Cancer.
The purpose of this study is to determine how well patients respond to different methods of giving treatment with an LHRH analogue in combination with an antiandrogen drug for the treatment of prostate cancer. Quality of life and the development of side effects are important in assessing this treatment.

Complexity Level: 2

Eligibility: Patients with histologically or cytologically confirmed adenocarcinoma of the prostate, clinical stage D2 as evidenced by soft tissue and/ or bony metastases.

Objectives: To compare survival and quality of life in patients randomized to either intermittent or continuous combined androgen deprivation therapy (CAD).

NCT Registration ID (from clinicaltrials.gov): NCT00002651
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: October 19, 1998 Closing Date: August 31, 2008

Permanently Closed
PR9 (P-0011)Phase III Clinical Trial for PT3 and/or Margin Positive Prostate Carcinoma Following Radical Prostatectomy


Eligibility: Patients will have pathologic stage T3N0M0 prostate cancer at high-risk for PSA relapse as determined by GS > 7 and one or more of the following: 1) preoperative PSA > 10 ng/ml; 2) positive surgical margins; 3) seminal vesicle invasion. If Gleason score < 7, then two or more of the above factors. Patients who have negative LN status by lymph node sampling or LN dissection will be eligible. If pathologic LN status is unknown, the risk of involvement must be less than 5 % as determined by the Roach formula.

Objectives: To test, in a randomized study, if the addition of androgen suppression to radiation therapy in patients with unfavorable pathologic stage pT3N0M0 prostate cancer leads to better outcome than each used separately. The endpoints will be overall survival, disease-free survival, freedom from distant metastases, and freedom from PSA failure. To compare the qualitative and quantitative toxicities of patients with pT3N0M0 prostate cancer treated adjuvantly with androgen suppression and radiation therapy to that of adjuvant radiation therapy or androgen suppression alone.

NCT Registration ID (from clinicaltrials.gov): NCT00023829
Participation: Limited to centres with a current CPA/FWA #
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: February 25, 2004 Closing Date: May 07, 2004

Chair: (Canada) Dr. Laurence Klotz, Odette Cancer Centre, (416) 480-4673


Permanently Closed
PRC2 (CALGB C90202)A Randomized, Double-Blind, Placebo-Controlled Phase III Study of Early Versus Standard Zoledronic Acid to Prevent Skeletal Related Events in Men with Prostate Cancer Metastatic to Bone
The purpose of this study is to compare the effects (good and bad) of early treatment with zoledronic acid compared to standard treatment with zoledronic acid. To do this, half of the patients in this study will get zoledronic acid and the other half will receive a placebo (a substance that does not do anything). This research is being done because we know that treatment with zoledronic acid decreases the risk of certain skeletal (bone) related risks in men with prostate cancer after the cancer has spread to the bones. The cancer continues to grow even with hormonal therapy (standard treatment). This research is being done because we do not know whether earlier treatment with zoledronic acid (started before the cancer grows with hormonal therapy) is better or worse than standard treatment.

Complexity Level: 2

Eligibility: 1) Histologic documentation of prostate adenocarcinoma. 2) At least one bone metastasis by radiographic imaging 3) While on this study, patients must receive androgen deprivation therapy (ADT) for treatment of prostate cancer. 4) No prior treatement with bisphosphonates. 5) No prior treatment with radiation and hormones as sepcified in section 5.4 of the protocol. 6) ECOG (CTC) performance status 0-2. 7) Min. Age 18. 8) Baseline laboratory data should fall within protocol required limits.

Objectives: Primary objective: To determine whether treatment with zoledronic acid at the time of initiation of androgen deprivation therapy for metastatic prostate cancer will delay the time to first skeletal related event. Secondary objective: To determine whether treatment with zoledronic acid will decrease the proportion of men with one or more vertebral fractures at two years compared to placebo in men receiving androgen deprivation therapy for metastatic prostate cancer.

NCT Registration ID (from clinicaltrials.gov): NCT00079001
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): No
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: February 07, 2006 Closing Date: April 02, 2012

Chair: (Canada) Dr. Fred Saad, CHUM-Centre Hospitalier de l'Universite de Montreal, (514) 890-8000 Ext. 27466


Permanently Closed
PRP1A Double-Blind, Placebo-Controlled, Randomized Study of Combination Vitamin E, Selenium and Soy Protein Product in Subjects With High Grade Prostatic Intraepithelial Neoplasia
The purpose of this study is to see if soybean product plus vitamin E and selenium can prevent the development of prostate cancer in men with PIN cells. To do this, half of the subjects in the study will receive a nutritional supplement containing soybean product, vitamin E and selenium and the other half will receive a placebo (a substance that does not do anything).

Eligibility: Documented high grade prostatic intraepithelial neoplasia (HGPIN) confirmed by the central reference pathologist. Two prostate biopsies performed within 18 months of randomization with the most recent within 6 months of randomization. Both biopsies must be negative for invasive prostate cancer.

Objectives: To compare disease free survival, changes in serum PSA, oxidative biomarkers and hormone levels with nutrient supplement, containing vitamin E, selenium and soy protein, or placebo. To determine the association between prostate cancer development and exposure to various hypothesized risk factor for prostate cancer and to evaluate the safety of the treatment.

NCT Registration ID (from clinicaltrials.gov): NCT00064194
Participation: Not limited
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: November 28, 2001 Closing Date: July 23, 2004

Chair: (Canada) Dr. Neil Fleshner, University Health Network, (416) 946-4501 Ext. 2899


Permanently Closed
PRP1BAn Investigation of Molecular and Genetic Risk Factors Associated With Development of Prostate Cancer in Subjects With High Grade Prostatic Intraepithelial Neoplasia Treated With Placebo or Combination Vitamin E, Selenium and Soy Protein Product
The purpose of these studies is to better understand the nature of high grade prostatic intraepithelial neoplasia and to determine how subjects respond to treatment with vitamin E, selenium and soy protein product.

Eligibility: Subjects who have met the eligibility criteria for and were previously enrolled in the NCIC CTG PRP.1 study: A double-blind, placebo-controlled, randomized study of combination vitamin E, selenium and soy protein product in subjects with high grade prostatic intraepithelial neoplasia.

Objectives: To determine if molecular, genetic and immunohistochemical markers are associated with progression from high grade PIN to cancer. To determine if molecular or immunohistochemistry changes can occur in PIN among men treated with combination vitamin E, selenium and soy compared to placebo. To determine if cancers that arise within the PRP.1 study differ in terms of their proliferative capacity as measured by nuclear factor kappa B, p27 and ki-67, and to bank biopsy material, serum and DNA for future studies.

Participation: Limited to subjects enrolled on the PRP.1 study.
NCI US Affiliation: No
Clinical Trials Application (Canada): No
Coordination: NCIC CTG Led Trial
Status: Permanently Closed
Activation Date: July 29, 2005 Closing Date: April 17, 2009

Chair: (Canada) Dr. Neil Fleshner, University Health Network, (416) 946-4501 Ext. 2899


Permanently Closed
REC1 (CALGB C90206)A Phase III Trial of Interferon-Alpha (IFNA) or IFNA Plus Bevacizumab in Advanced Renal Cell Cancer


Complexity Level: 2

Eligibility: Patients with advanced renal cell cancer.

NCT Registration ID (from clinicaltrials.gov): NCT00072046
Participation: Open to member centres
NCI US Affiliation: Yes
Clinical Trials Application (Canada): Yes
Coordination: Intergroup Led Trial
Status: Permanently Closed
Activation Date: April 23, 2004 Closing Date: July 01, 2005

Permanently Closed