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

Are you eligible to participate in this study?

You may be eligible for this study if you meet the following criteria:

  • Conditions:
    Prostate Cancer
  • Age: Between 18 - 100 Years
  • Gender: Male
  • Other Inclusion Criteria:
    1. Histologically or cytologically confirmed adenocarcinoma of prostate
    2. Have a specific medical imaging test called prostate-specific membrane antigen positron emission tomography/computed tomography (PSMA PET/CT) within the 30-day screening period
    3. Prostate cancer initially treated by: a) radical prostatectomy (RP) followed by adjuvant radiotherapy (ART) or salvage radiotherapy (SRT) b) RP in participants who are unfit for ART or SRT c) primary radiotherapy (RT)

You may not be eligible for this study if the following are true:

    1. Pathological findings indicate the presence of either small cell carcinoma, ductal carcinoma, or a component of neuroendocrine carcinoma that makes up at least 50% of the prostate tissue
    2. History of bilateral orchiectomy
    3. Brain metastasis on PSMA PET /CT by BICR at screening



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