RecoverPC: Relugolix vs GnRH Agonist in Quality of Life

Launched by DANA-FARBER CANCER INSTITUTE · Mar 1, 2023

Keywords

ClinConnect Summary

The RecoverPC trial is studying how two approved treatments for prostate cancer, leuprolide and relugolix, affect patients' quality of life, as well as their blood levels, cholesterol, and blood sugar. Both medications are already standard treatments for prostate cancer, and this study aims to see how they compare when used as prescribed. The trial is currently looking for male participants aged 18 and older who have been diagnosed with prostate cancer and are eligible for at least six months of treatment with one of these drugs. Participants should not have received certain other cancer treatments or have specific health issues that could interfere with the study.

If you join the study, you can expect to take either leuprolide or relugolix as part of your treatment for prostate cancer. You'll also be monitored for any changes in your health and well-being throughout the trial. It's important to note that participants must understand the study and agree to use contraception during the trial, as the effects of these medications on pregnancy are not fully known. This trial could provide valuable insights into how these treatments impact everyday life for men with prostate cancer.

Gender

MALE

Eligibility criteria

• Inclusion Criteria:
• • Participants must have a histologic diagnosis of prostate adenocarcinoma.
• • Participants must be eligible for treatment with 6 months of ADT with leuprolide depot or relugolix without additional systemic therapies other than first generation androgen receptor antagonists (eg. bicalutamide, nilutamide, flutamide).
• • Participants cannot have received prior GnRH agonist or antagonist therapy.
• • Patients must have testosterone level \> 200 ng/mL prior to initiation of ADT.
• • Age ≥18 years.
• • ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A).
• • Life expectancy of greater than 12 months
• * Participants must have adequate organ and marrow function as defined below:
• • leukocytes ≥3,000/mcL
• • absolute neutrophil count ≥1,500/mcL
• • platelets ≥100,000/mcL
• • total bilirubin ≤ institutional upper limit of normal (ULN) unless known or suspected Gilbert syndrome
• • AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN
• • creatinine ≤ institutional ULN OR
• • glomerular filtration rate (GFR) ≥50 mL/min/1.73 m2 unless data exists supporting safe use at lower kidney function values, no lower than 30 mL/min/1.73 m2 (see Appendix B).
• • Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial.
• • For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated.
• • Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load.
• • Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial.
• • Participants with known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Functional Classification. To be eligible for this trial, participants should be class 2B or better.
• • The effects of relugolix and leuprolide on the developing human fetus are unknown. For this reason and because GnRH agents are known to be teratogenic, women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately. Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 4 months after completion of relugolix or leuprolide depot administration.
• • Ability to understand and the willingness to sign a written informed consent document.
• Exclusion Criteria:
• • History of major adverse cardiac event, including myocardial infarction, new congestive heart failure (CHF) or CHF exacerbation, or stroke, within the past 6 months.
• • Participants who have prior or planned concurrent treatment with second generation AR targeted therapies (such as abiraterone, enzalutamide, darolutamide, apalutamide).
• • Participants who are receiving any other investigational agents.
• • Patients with brain metastases will be excluded from the study as intermittent hormonal therapy is not standard of care treatment for this population.
• • History of allergic reactions attributed to compounds of similar chemical or biologic composition to leuprolide depot or relugolix.
• • Participants with uncontrolled intercurrent illness.
• • Participant is unable to swallow pills.