A randomized double-blind placebo-controlled Phase 3 study of darolutamide plus androgen deprivation therapy (ADT) compared with placebo plus ADT in patients with high-risk biochemical recurrence (BCR) of prostate cancer

Brief description of study

This is a research study that aims to determine if adding darolutamide to the standard treatment, ADT (referred to as androgen deprivation therapy which is used to suppress or block the production or action of male hormones), for 24 months is more effective than a placebo plus ADT in participants with high-risk prostate cancer that has recurred with a rising PSA. The study will use imaging tests (PSMA PET/CT) to assess the time it takes for new cancer lesions to appear (rPFS) and the time it takes for new cancer lesions to appear using other imaging methods (MFS). Participants will be randomly assigned to receive either darolutamide or a placebo for 24 months. All participants will also receive standard hormone therapy for 24 months. The study will have different phases, including screening, treatment, follow-up, and long-term follow-up.

Clinical Study Identifier: s23-00168

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