Dana-Farber Cancer Institute
This study is testing the way that approved androgen deprivation therapy treatments, Leuprolide and Relugolix, for prostate cancer affect quality of life, blood levels, cholesterol, and blood sugar. The drugs are already standard treatment for people with prostate cancer, and the drugs will be used as described in their label. The names of the study drugs involved in this study are: * Leuprolide (type of ADT) * Relugolix (type of ADT)
This is a phase 2 clinical trial comparing patient-reported Quality of Life (QOL) among men with localized or biochemically recurrent prostate cancer treated with relugolix versus leuprolide depot therapy. Participants will be randomized into one of the study groups leuprolide versus relugolix. Randomization means that a participant is put into a study group by chance. The U.S. Food and Drug Administration (FDA) has approved leuprolide and relugolix as treatment options for prostate cancer. The research study procedures include screening for eligibility and study treatment including evaluat…
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 gr…
Gonadotropin-releasing hormone (GnRH) antagonist, oral tablet taken 1x daily.
Gonadotropin-releasing hormone (GnRH) antagonist, intramuscular injection 1x every 3 months.
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