The DASL-HiCaP trial, led by the Australian and New Zealand Urogenital and Prostate Cancer Trials Group (ANZUP), enrolled its first patient at Chris O’Brien Lifehouse in Camperdown in Sydney.
Prostate cancer remains the most common cancer in Australian men and the leading cause of cancer related-mortality for men in developed countries.
The new randomised phase 3 study aims to demonstrate that the addition of the new potent oral hormonal therapy, darolutamide, to the standard radiation therapy and testosterone suppression improves the outcomes of men with localised high-risk prostate cancer.
Outcomes of the trial will be measured in terms of whether the addition of darolutamide decreases the risk of spreads of prostate cancer to other parts of the body as well as improving quality of life and potentially decrease the risk of prostate cancer death.
“At ANZUP we remain committed to running our clinical trials and delivering the best standard of care for those people impacted by genitourinary cancers. COVID-19 has presented challenges to each and every one of us across the globe, as it has with the day to day running of our trials, and the safety of our patients and site personnel remains our top priority."“Men who are eligible for DASL-HiCaP need therapy that cannot be delayed. We have no evidence that darolutamide increases the risk of infections, and many of the clinical sites that will run the trial agreed with ANZUP that it is appropriate to activate the trial and be able to offer patients the opportunity to participate. We know clinical trials are the only way to find out the safety and effectiveness of new treatments and whether they should become the new gold standard for treatment in the future. We, therefore, remain dedicated to running these trials. It is very pleasing to see our DASL-HiCaP trial enroll its first participant, and help us move closer to our goal of improving outcomes for those men with high risk, clinically localised prostate cancer,” said ANZUP Chair, Professor Ian Davis.
The first patient enrolled marks the start of the journey to recruit and follow up 1,100 eligible patients across over 100 cancer centres across Australia, New Zealand, US, Canada, UK, and Ireland.
Study Co-Chairs Associate Professor Tamim Niazi and Professor Christopher Sweeney are very optimistic about the potential this trial has for patients.
“DASL-HiCaP is specifically designed to assess whether this novel hormone treatment added to standard therapy can lessen the risk of recurrence of prostate cancer in men with prostate cancer with features with a high risk of spreading to other parts of the body. The patients in this study will be men treated with standard testosterone suppression along with radiation, or radiation after surgery. Our hope is that this trial might show new ways of improving outcomes for these men with prostate cancer,” said Professor Christopher Sweeney.Source: "First Patient Enrolled in Sydney in Worldwide Prostate Cancer Trial." 2020. Anzup.Org.Au.2020.
ANZUP Cancer Trials Group Limited
Clinical Trial Information: NCT04136353 DASL-HiCaP: Darolutamide Augments Standard Therapy for Localised Very High-Risk Cancer of the Prostate (ANZUP1801): A Randomised Phase 3 Double-blind, Placebo-controlled Trial of Adding Darolutamide to Androgen Deprivation Therapy and Definitive or Salvage Radiation in Very High Risk, Clinically Localised Prostate Cancer