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RecoverPC: Relugolix vs. Leuprolide for Prostate Cancer Quality of Life

This study, called RecoverPC, is looking at how two approved prostate cancer treatments, Relugolix and Leuprolide, affect your quality of life. Both drugs are standard treatments for prostate cancer. Relugolix is a daily pill, and Leuprolide is an injection given every three months. Researchers want to understand how these drugs impact your overall well-being, blood levels, cholesterol, and blood sugar. You might be able to join if you are a man aged 18 or older with a specific type of prostate cancer (adenocarcinoma) and are eligible for 6 months of hormone therapy (ADT) with either Relugolix or Leuprolide. The main goal is to compare quality of life scores after 9 months of treatment. About 110 people are expected to participate.

Study design
This is a Phase 2 interventional study where participants are randomly assigned to receive either Relugolix or Leuprolide. Approximately 110 men are expected to participate.
What's involved
You would undergo screening, receive study treatment, and have evaluations, follow-up visits, ECGs (heart tests), and blood tests. Your participation is expected to last 12 months.
Compensation
Not stated in the trial record.
Follow-up
The primary quality of life measurement is taken at 9 months, and overall participation is expected to last 12 months.

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NCT05765500

RecoverPC: Relugolix vs GnRH Agonist in Quality of Life

Recruiting
PHASE2Ages 18+InterventionalTreatment
Dana-Farber Cancer Institute
~110 participants
Updated 2026-07-30 on ClinicalTrials.gov
What's tested:RelugolixLeuprolide

At a glance

Recruiting sites
2 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
9-month Quality of Life (QOL) Score
Measured over At 9 months

Conditions

Prostate Cancer
Prostatic Neoplasms

Explore related trials

Prostate Carcinoma

Where it's being run

3 sites across 1 states
Massachusetts3

Study leadership

  • Alicia Morgans, MD · PRINCIPAL_INVESTIGATOR · Dana-Farber Cancer Institute

Who to contact

Alicia Morgans, MD
[email protected]
857-215-1605
Email the study team

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Eligibility criteria

Inclusion

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

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.

What this trial measures

  • 9-month Quality of Life (QOL) ScoreAt 9 months

    The QOL assessed using Functional Assessment of Cancer Therapy - Prostate (FACT-P) questionnaire, defined protocol section 11.1.1: The FACT-P (version 4) contains 39 Likert-type items distributed over 5 subscales: physical (7 items), social/family (7 items), emotional (6 items), and functional (7 items) well-being, and the additional concerns related to prostate cancer scale (12 items). The FACT-P total score is calculated by summing all these 5 subscales and ranges from 0 to 156.