Kurzfassung

The purpose of this study is to evaluate whether the addition of darolutamide to ADT given for a pre-specified duration of 24 months provides superior efficacy compared with 24 months of placebo plus ADT based on radiological progression-free survival (rPFS) by prostate-specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) as assessed by blinded independent central review (BICR) in patients with high-risk biochemical recurrence (BCR) of prostate cancer....The purpose of this study is to evaluate whether the addition of darolutamide to ADT given for a pre-specified duration of 24 months provides superior efficacy compared with 24 months of placebo plus ADT based on radiological progression-free survival (rPFS) by prostate-specific membrane antigen (PSMA) positron emission tomography/computed tomography (PET/CT) as assessed by blinded independent central review (BICR) in patients with high-risk biochemical recurrence (BCR) of prostate cancer. The patient population of this study is a high-risk BCR population, having exhausted all options of local therapies with curative intent (primary radiotherapy [RT] or radical prostatectomy [RP] + adjuvant radiotherapy [ART] or + salvage radiotherapy [SRT]), or patients who are unfit for ART or SRT who also have a short prostate-specific antigen doubling time (PSADT) <12 months and at least one PSMA PET/CT positive lesion of prostate cancer assessed by BICR.» weiterlesen» einklappen