Posted: Wednesday, April 5, 2023
The impact of the oral androgen receptor inhibitor darolutamide on localized prostate cancer with very high–risk features is being evaluated in a randomized phase III study called DASL-HiCaP, which was included as a trial in progress poster during the 2023 American Society of Clinical Oncology (ASCO) Genitourinary (GU) Cancers Symposium (Abstract TPS396). Tamim Niazi, MD, of Jewish General Hospital, McGill University, Montréal, and colleagues said the team’s goal in the 1,100-patient, double-blind, international trial is to determine the efficacy of adding darolutamide to androgen-deprivation therapy and radiation therapy, used either as primary definitive therapy or as salvage therapy, for this population.
For 96 weeks, half the men will receive darolutamide at 600 mg twice daily, and the other half will receive placebo, in combination with the standard of care—luteinizing hormone–releasing hormone analog—plus radiation therapy, starting at a point between weeks 8 and 24 following randomization. Alone, this standard-of-care regimen can offer some success, explained the investigators, but “incurable distant metastases develop within 5 years in 15% of patients with very high–risk features.”
All participants (who plan to undergo radiation therapy) were determined by conventional imaging to have very high–risk localized prostate cancer or very high–risk features with persistent or increased prostate-specific antigen (PSA) levels within 1 year of radical prostatectomy. “The trial is stratified by previous radical prostatectomy, planned use of adjuvant docetaxel, and clinical or pathological pelvic nodal involvement,” explained the investigators.
The study’s primary endpoint is metastasis-free survival, with secondary endpoints including overall survival, prostate cancer–specific survival, PSA progression–free survival, time to subsequent hormonal therapy, time to castration resistance, and frequency and severity of adverse events.
Disclosure: The study authors’ disclosure information can be found at asco.org.