Prostate Androgen Response Investigation using a Stratification BIOmarker - PARIS-BIO

Prior treatment

• Prior treatment with androgen receptor antagonists
• Treatment with gonadotropin-releasing hormone (GnRH)
• History of prior systemic or local therapy for prostate cancer, including pelvic radiation to the prostate
• Major surgery <=4 weeks prior to inclusion

Other

• ≥M1 or ≥N2

• Patients must be >= 18 years of age
• A clinically relevant Prostate MRI
• Biopsy confirmed high-risk prostate cancer defined as a global ISUP-score ≥4 with any MRI PIRADS score or global ISUP=3 with any MRI PIRADS score =5
• Candidate for radical prostatectomy
• Eastern Cooperative Oncology Group (ECOG) Performance Status score of 0 or 1
• Able to receive Darolutamide for 90-120 days
• Signed informed consent form
• A participant who is sexually active is eligible if he is willing to use a condom from the screening visit up to 1 week after last dose of Darolutamide except if the male participant is sterile (e.g. vasectomised); the unique female sexual partner is postmenopausal, is permanently sterilized (e.g. hysterectomy or tubal ligation) or use a highly effective method of contraception (< 1% documented failure rate).
• Able to understand and comply with planned study procedures and willing to be available for all study-required procedures, visits and calls for the duration of the study.