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.
Parallel
Darolutamide 300 mg
Drug600 mg po, b.i.d.
Placebo
Drugpo, b.i.d.
Androgen deprivation therapy
DrugUse according to local standard of care
Radiographic progression-free survival
Time from randomisation to radiographic progression according to the Prostate Cancer Working Group 3 (PCWG3) criteria or death, whichever occurs first
Castration-resistant prostate cancer-free survival
Time from randomisation to onset of castrate resistant prostate cancer (CRPC) according to PCWG3 criteria, or death, whichever occurs first
Clinical progression-free survival
Time from randomisation to first occurrence of any one of the following: (i) Cancer pain deterioration (2-point deterioration from baseline according to the Brief Pain Inventory - Short Form \[BPI-SF\] questionnaire; initiation of opioid therapy, or a ≥30% increase in opiate use) (ii) Any deterioration of physical function measured using the 4-IADL assessment tools (Lawton, 1969) (iii) A deterioration in ECOG performance status of at least 2 points from baseline (iv) Death from any cause.
Overall survival
Time from randomisation to the time of death from any cause
Frequency and severity of adverse events
The National Cancer Institute-Common Terminology Criteria for Adverse Events version 5 (NCI-CTCAE v5) is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale, divided into 5 grades (1 = "mild", 2 = "moderate", 3 = "severe", 4 = "life-threatening", and 5 = "death") determined by the investigator, will make it possible to assess the severity of the disorders
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UNICANCER
Lead sponsor
Bayer
Collaborator
