Actively Recruiting
RecoverPC: Relugolix vs GnRH Agonist in Quality of Life
Led by Dana-Farber Cancer Institute · Updated on 2025-08-11
110
Participants Needed
3
Research Sites
202 weeks
Total Duration
On this page
Sponsors
D
Dana-Farber Cancer Institute
Lead Sponsor
P
Prostate Cancer Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
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)
CONDITIONS
Official Title
RecoverPC: Relugolix vs GnRH Agonist in Quality of Life
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologic diagnosis of prostate adenocarcinoma
- Eligible for 6 months of ADT with leuprolide depot or relugolix without other systemic therapies except first generation androgen receptor antagonists
- No prior GnRH agonist or antagonist therapy
- Testosterone level greater than 200 ng/mL before starting ADT
- Age 18 years or older
- ECOG performance status 2 or better (Karnofsky 60% or higher)
- Life expectancy greater than 12 months
- Adequate organ and marrow function including leukocytes 653000/mcL, neutrophils 651500/mcL, platelets 65100,000/mcL, bilirubin within normal limits or Gilbert syndrome, AST/ALT less than 3 times upper limit, creatinine within normal limits or GFR at least 50 mL/min/1.73 m2 (minimum 30 if supported)
- HIV-infected participants on effective antiretroviral therapy with undetectable viral load within 6 months
- For chronic hepatitis B infection, undetectable viral load on suppressive therapy if needed
- Participants with hepatitis C infection must be treated and cured or have undetectable viral load if currently on treatment
- Participants with prior or concurrent malignancies not interfering with safety or efficacy assessment
- Cardiac function assessed as New York Heart Association class 2B or better
- Agreement to use adequate contraception during study and for 4 months after treatment completion
- Ability to understand and sign informed consent
You will not qualify if you...
- History of major cardiac events including myocardial infarction, new or worsening congestive heart failure, or stroke within past 6 months
- Prior or planned treatment with second generation androgen receptor targeted therapies
- Receiving other investigational agents
- Brain metastases
- Allergic reactions to leuprolide depot or relugolix or related compounds
- Uncontrolled intercurrent illness
- Unable to swallow pills
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02215
Not Yet Recruiting
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Actively Recruiting
3
Dana-Farber Cancer Institute at Foxborough
Foxborough, Massachusetts, United States, 02035
Actively Recruiting
Research Team
A
Alicia Morgans, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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