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

Launched by UNIVERSITY HEALTH NETWORK, TORONTO · Nov 22, 2019

Keywords

ClinConnect Summary

This clinical trial is studying whether adding two hormone therapies, darolutamide and degarelix, to standard radiation therapy will improve treatment for men with intermediate-risk prostate cancer. Prostate cancer is common among men, and while some treatments can cure it, others may not work as well, leading to uncertainty in how to treat individual patients. The researchers believe that certain characteristics of the cancer cells can help identify which men might benefit from more intensive treatment.

To participate in this study, men must be 18 years or older with a confirmed diagnosis of prostate cancer that meets specific criteria, such as certain levels of a blood test called PSA and particular features of the cancer cells. Participants will receive radiation therapy, and some will also get the hormone therapies for six months. They will be monitored for five years to evaluate how well the treatment works and to check for any side effects. It's important to note that darolutamide is still considered experimental and can only be used in this study.

Gender

MALE

Eligibility criteria

• 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.