Study of Radiation Therapy in Combination With Darolutamide + Degarelix in Intermediate Risk Prostate Cancer

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.