Inclusion Criteria:

          -  Male ≥ 18 years of age;

          -  Pathologic (histologic) proven diagnosis of prostate adenocarcinoma within 180 days
             prior to consent;

          -  PSA measurement performed within 60 days prior to consent;

          -  IR-PCa as per National Comprehensive Cancer Network (NCCN) criteria (PSA >10 and < 20
             ng/mL and/or Gleason score 7 and/or T-category T2b-T2c clinical or ultrasound);

          -  UIR-PCa, at least one of the following:

          -  2 or 3 NCCN IR-PCa criteria;

          -  Gleason score 4+3;

          -  >50% diagnostic cores involved by adenocarcinoma;

          -  Clinically negative (N0) stage, as defined by pelvic-CT or pelvic-MRI within 4 months
             prior to consent;

          -  No evidence of bone metastases (M0) assessed by a bone scan within 4 months prior to
             consent;

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2;

          -  Able and willing to provide signed informed consent as per International Conference on
             Harmonization - Good Clinical Practices Guidelines (ICH-GCP) and applicable
             regulations.

        Exclusion Criteria:

          -  Received any form of hormonal therapy such as bilateral orchiectomy, LHRH
             agonist/antagonist (e.g. goserelin, leuprolide, degarelix, etc.), anti-androgens (e.g.
             flutamide, bicalutamide, etc.), 5α-reductase inhibitors (e.g. finasteride,
             dutasteride, etc.) and/or estrogens within 1 year of consent;

          -  Received prior cytotoxic therapy for prostate cancer (e.g. taxanes, mitoxantrone);

          -  Currently taking medications that might cause toxicity if combined with darolutamide
             (see section 4.6);

          -  Hemoglobin < 9.0 g/dL, independent of transfusion and/or growth factors, measured
             within 90 days prior to consent;

          -  Platelet count < 100,000 × 109/μL, independent of transfusion and/or growth factors,
             within 90 days prior to consent;

          -  Serum albumin < 3.0 g/dL within 90 days prior to consent;

          -  Abnormal renal function, assessed within 90 days prior to consent:

          -  Creatinine > 2mg/dL;

          -  Glomerular filtration rate (GFR) ≤ 35 mL/min, estimated by Cockcroft-Gault formula or
             measured directly by 24 hour urine.

          -  Abnormal liver function assessed within 90 days prior to consent:

          -  Total bilirubin > 1.5 times the upper limit of normal range;

          -  Aminotransferases (ALT or AST) >1.5 times the upper limit of normal range;

          -  Currently on anticoagulant therapy for any indication (e.g. atrial fibrillation, valve
             replacement, pulmonary embolism, etc.);

          -  Any cardiac events (e.g. unstable angina, myocardial infarction and/or congestive
             heart failure;

          -  Does not agree to use highly effective method of birth control if he is having sex
             with a woman of childbearing potential or does not agree to use a condom if he is
             having sex with a woman who is pregnant while on study drug and for 4 weeks following
             the last dose of study drug;

          -  Known hypersensitivity (or known allergic reaction) to the study treatment(s) or any
             of its ingredients (as listed in Investigator's brochure);

          -  Planned initiation of alternative therapy for prostate cancer or investigational
             therapy;

          -  Participation in another interventional clinical trial during and / or within 3 months
             of consent for this study;

          -  Subject was previously randomized in this trial;

          -  Any psychological, familial, sociological or geographical condition potentially
             hampering compliance with the study protocol and follow-up schedule; those conditions
             should be discussed with the patient before registration in the trial.