Early findings from the PR.22 trial  show promise in delaying the spread of high-risk prostate cancer

Interim results from the CCTG PR.22 (DASL-HiCaP ANZUP 1801) clinical trial, has seen a delay in the spread of prostate cancer. The findings were presented at the Presidential Symposium at European Society for Medical Oncology (ESMO) Congress in Madrid, Spain, held October 23–27, 2026.

Sponsored by the University of Sydney and jointly led by the Sydney Clinical Trials Centre (CTC) and the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP), the international study is investigating whether adding an oral androgen receptor inhibitor to standard radiation and hormone therapy can improve outcomes for people with very high-risk localized or locally advanced prostate cancer. Researchers studied whether this combination could delay cancer spreading to other parts of the body, potentially improving long-term outcomes for patients with high-risk disease. By targeting the androgen receptor, which helps prostate cancer cells grow, the investigational treatment may offer an additional way to control the disease alongside established therapies.

“Early results indicate that intensifying standard radiation and hormone therapy with Darolutamide may decrease the risk of metastatic spread in prostate cancer patients at higher risk of disease recurrence or progression,” says Dr. Tamim Niazi, the DASL-HiCaP study co-chair and Radiation Oncologist at Jewish General Hospital. “If supported by longer-term data, this approach offers a meaningful opportunity to extend the time patients live without cancer progression.”

According to the interim analysis, participants who received the additional treatment experienced longer metastasis-free survival than those who received placebo.¹ The analysis also observed fewer prostate cancer deaths and a longer time before prostate-specific antigen (PSA) levels rose.¹ These findings were observed when approximately two-thirds of the planned metastasis-free survival events had occurred, participant follow-up is continuing.

About 1 in 8 Canadian men will develop prostate cancer in their lifetime and approximately 29,300 are diagnosed each year. People with very high-risk localised or locally advanced prostate cancer remain at risk of their cancer returning or spreading despite current treatment approaches. These findings highlight the importance of international collaboration in advancing prostate cancer research and evaluating new treatment approaches for patients at high risk of cancer progression.

“As a prostate cancer patient, I am very pleased with the interim results for the PR.22 trial,” says Bill Richardson, CCTG Patient Representative. “For men in this population, the study offers the prospect of a new standard of care that could increase the time until cancer reoccurrence, improve overall survival rates, and extend the time before PSA levels begin to rise.”

About DASL-HiCaP trial (ANZUP 1801) (CCTG PR21)

DASL-HiCaP: Darolutamide augments standard therapy for localized very high-risk cancer of the prostate. A randomized phase 3 double-blind, placebo-controlled trial of adding darolutamide to androgen deprivation therapy and definitive or salvage radiation.

This investigator-initiated, international trial enrolled 1,106 participants across Australia, New Zealand, Canada, the United States, Ireland, and the United Kingdom. The randomised, double-blind, placebo-controlled study investigated whether adding an oral androgen receptor inhibitor to standard treatment could extend the time before cancer spread to other parts of the body was detected. All participants received radiation therapy and ADT, then were randomly assigned to receive either the study medicine or an identical placebo tablet. The primary outcome was metastasis-free survival—the time until cancer recurrence or spread was detected on standard scans, or death from any cause. The trial has closed to recruitment, and participants will continue to be followed over the longer term.

• ANZUP press release > 
• DASL-HiCaP ESMO 26 abstract >

References 

1. DASL-HiCaP trial Abstract/Presentation ESMO. Niazi T et al, Darolutamide with androgen-deprivation therapy and definitive or salvage radiation therapy for localised, very high-risk prostate cancer: an international, placebo-controlled, randomised phase 3 trial (DASL-HiCAP; ANZUP 1801). Abstract accepted for presentation at: European Society for Medical Oncology (ESMO) Congress 2026; 23-27 Oct 2026; Madrid, Spain.