This is a Phase III, international, multicentre, randomised, double-blinded placebo controlled trial, evaluating the efficacy and safety of ADT +/- darolutamide in castration-naïve de novo metastatic prostate cancer patients with vulnerable functional ability who have not elected for docetaxel or other androgen receptor pathway inhibitors.
Signed a written informed consent form prior to any trial specific procedures.
Men with histologically or cytologically confirmed adenocarcinoma of the prostate.
Aged ≥18 years old at the time of signing informed consent.
De novo metastatic disease defined by clinical or radiological evidence of metastases.
Three or more Grade 3, or any Grade 4 events on the CISR-G questionnaire. Nota Bene: (Regarding CISR-G assessment, more specifically genitourinary scoring, score N°4 is not applicable).
Eastern Cooperative Oncology Group (ECOG) performance status score ≥3.
Hypertension not controlled by an anti-hypertensive treatment (systolic blood pressure [BP] ≥160 mmHg or diastolic BP ≥95 mmHg; 3 consecutive measures taken 5 minutes apart).
Acute toxicities of prior treatments and procedures not resolved to grade ≤1 or baseline before randomisation, with the exception of hot flushes and erectile dysfunction.
UNICANCER
Lead sponsor
Bayer
Collaborator