RecoverPC: Relugolix vs GnRH Agonist in Quality of Life

NCT05765500 | Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: 22-599
• Study Type: interventional
• Target: 110
• Locations: 1 country
• Sites: 3

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

Keywords

Prostate Cancer; Prostate Neoplasms

Outcome Measures

Primary Outcomes (1)

• 9-month Quality of Life (QOL) Score

  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.

  At 9 months

Secondary Outcomes (6)

• 12-month Quality of Life (QOL) Score

  At 12 months

• 9-month Hot flash related daily interference scale (HFRDIS)

  At 9 months

• 9-month Insomnia Severity Index (ISI) Score

  At 9 months

• 9-month Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Score

  At 9 months

• 9-month EPIC-26 Sexual Function Summary Score

  At 9 months

Study Arms (2)

Arm A: Relugolix

EXPERIMENTAL

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.

Drug: Relugolix

Arm B: Leuprolide

ACTIVE COMPARATOR

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.

Drug: Leuprolide

Interventions

Relugolix DRUG

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

Also known as: Orgovyx

Arm A: Relugolix

Leuprolide DRUG

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

Also known as: Leuprolide Depot

Arm B: Leuprolide

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead
• Prostate Cancer Foundation: collaborator
• Pfizer: collaborator
• Myovant Sciences GmbH: collaborator

Study Sites (3)

Brigham and Women's Hospital

Boston, Massachusetts, 02215, United States

NOT YET RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

Dana-Farber Cancer Institute at Foxborough

Foxborough, Massachusetts, 02035, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

relugolix; Leuprolide

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Gonadotropin-Releasing Hormone; Pituitary Hormone-Releasing Hormones; Hypothalamic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Alicia Morgans, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alicia Morgans, MD

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 1, 2023
• First Posted: March 13, 2023
• Study Start: February 12, 2024
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: August 11, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US (3)