RecoverPC: Relugolix vs GnRH Agonist in Quality of Life
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorDana-Farber Cancer Institute
About this trial
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)
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Relugolix
- Leuprolide
Treatment groups
110 Participants
are divided into 2 treatment groupsSponsors and collaborators
Dana-Farber Cancer Institute
Lead sponsor
Prostate Cancer Foundation
Collaborator
Pfizer
Collaborator
Myovant Sciences GmbH
Collaborator
Source ClinicalTrials.gov