ESMO Virtual Congress 2020: DASL-HiCaP: Darolutamide Augments Standard Therapy for Localized Very High-Risk Cancer of the Prostate (ANZUP 1801)

(UroToday.com) Patients with high-risk localized prostate cancer who receive radiotherapy for management of their primary disease also receive LHRH analog therapy for at least one year or longer. Patients who undergo surgery for their localized prostate cancer but have persistent PSA and high-risk features such as lymph node involvement also undergo adjuvant radiation combined with LHRH analog therapy. Unfortunately, incurable distant metastatic disease develops within five years in a significant portion of men with high-risk features. ANZUP 1801/DASL-HiCaP (NCT04136353) is a double-blind placebo-controlled phase 3 clinical trial of the addition of the androgen receptor antagonist darolutamide to standard radiation and testosterone suppression in high-risk patients.

The trial schema is shown below.

The study aims to recruit 1100 men across 100 sites in 6 countries. The primary endpoint is metastasis-free survival, with key secondary endpoints of overall survival, prostate cancer specific survival, PSA progression free survival, time to subsequent hormonal therapy and time to castration-resistance.

Presented by: Tamim Niazi, MDCM, Jewish General Hospital, Montreal, Canada

Written by: Alok Tewari, MD, PhD, Medical Oncologist at the Dana-Farber Cancer Institute, at the 2020 European Society for Medical Oncology Virtual Congress (#ESMO20), September 19^th-September 21^st, 2020.

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