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.