Recruiting
Phase 2

Relugolix vs. GnRH Agonist

Sponsor:

Dana-Farber Cancer Institute

Code:

NCT05765500

Conditions

Prostate Cancer

Prostatic Neoplasms

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Relugolix

Leuprolide

Study Details

Brief summary:

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

Prostate Cancer

Prostatic Neoplasms

Study ID

NCT05765500

Start date

Feb 12, 2024

Status verified date

Jul, 2026

Completion date

Jan 1, 2028

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

110 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Arm A: Relugolix

55 participants will be randomized in a 1:1 fashion to Relugolix and stratified by intent to treat with radiation and will complete study procedures as outlined:

  • Surveys at baseline and at months 3, 6, 9, and 12.
  • Medication diary entries.
  • Cycles 1 - 6:

--Days 1 - 28 of 28 day cycle: Predetermined dose of Relugolix. Participant will self-administer at home.
  • Follow up visits every 3 months for 12 months.

active comparator: Arm B: Leuprolide

55 participants will be randomized in a 1:1 fashion to Leuprolide and stratified by intent to treat with radiation and will complete study procedures as outlined:

  • Surveys at baseline and at months 3, 6, 9, and 12.
  • Cycle 1 and Cycle 4:

--Day 1 of 28 day cycle: Predetermined dose of Leuprolide. Injection will be administered in clinic.
  • Follow up visits every 3 months for 12 months.

Interventions

Relugolix

Gonadotropin-releasing hormone (GnRH) antagonist, oral tablet taken 1x daily.

Leuprolide

Gonadotropin-releasing hormone (GnRH) antagonist, intramuscular injection 1x every 3 months.

Primary outcome measure

  • 9-month Quality of Life (QOL) Score [ Time Frame: At 9 months ]

Central Contacts and Locations

Central contacts

Alicia Morgans, MD

857-215-1605aliciak_morgans@dfci.harvard.edu

Locations

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 02215

Contacts

Alicia Morgans, MD

857-215-1605aliciak_morgans@dfci.harvard.edu

Dana-Farber Cancer Institute at Foxborough

Recruiting

Foxborough, Massachusetts, United States, 02035

Contacts

Daniel Roberts, MD

508-543-1700Daniel_Roberts@DFCI.HARVARD.EDU

More Information

Sponsor

Dana-Farber Cancer Institute

Last update posted

Jul 30, 2026

Last verified

Jul, 2026

Keywords

  • Prostate Cancer
  • Prostate Neoplasms

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Dana-Farber Cancer Institute on 2026-07-30.