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GnRH Agonist

Relugolix vs Leuprolide for Prostate Cancer

Phase 2
Recruiting
Led By Alicia Morgans, MD
Research Sponsored by Dana-Farber Cancer Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
ECOG performance status ≤2 (Karnofsky ≥60%).
Participants must have a histologic diagnosis of prostate adenocarcinoma.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 9 months
Awards & highlights

Study Summary

This trial tests how the standard prostate cancer treatments, Leuprolide & Relugolix, affect quality of life, blood levels, cholesterol, & blood sugar.

Who is the study for?
Men over 18 with prostate cancer who need androgen deprivation therapy (ADT) but haven't had it before. They must be able to sign consent, have a testosterone level >200 ng/mL, good organ function, no prior GnRH treatments, and agree to use contraception. Excludes those with allergic reactions to similar drugs or recent major heart events.Check my eligibility
What is being tested?
The trial compares the effects of two ADT medications for prostate cancer—Relugolix and Leuprolide—on quality of life, blood levels, cholesterol, and blood sugar. Participants will receive one of these standard treatments as per their labeling instructions.See study design
What are the potential side effects?
Possible side effects include hot flashes, fatigue, sexual dysfunction, bone density loss which could lead to fractures or osteoporosis; changes in mood or memory; injection site pain for Leuprolide; increased risk for heart disease.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I can take care of myself but might not be able to do heavy physical work.
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My cancer is diagnosed as prostate adenocarcinoma.
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I can be treated with hormone therapy for 6 months without other systemic treatments.
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I am 18 years old or older.
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I have chronic HBV but it's under control with treatment.
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I had hepatitis C but am now cured or have no detectable virus while on treatment.
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I have never been treated with GnRH therapies.
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My blood counts and liver/kidney functions are within normal ranges.
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My heart condition does not severely limit my daily activities.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 9 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 9 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
9-month Quality of Life (QOL) Score
Secondary outcome measures
12-month Hot flash related daily interference scale (HFRDIS)
12-month Quality of Life (QOL) Score
9-month EPIC-26 Sexual Function Summary Score
+3 more

Side effects data

From 2020 Phase 3 trial • 388 Patients • NCT03049735
11%
Hot flush
11%
Headache
5%
Hypertension
3%
Arthralgia
1%
Upper respiratory tract infection
1%
Avulsion fracture
1%
Ankle fracture
1%
Uterine myoma expulsion
1%
Haematemesis
1%
uterine leiomyoma
1%
Menorrhagia
1%
Pelvic pain
1%
Rhabdomyolysis
1%
Cough
1%
Vitreous detachment
1%
Hypothyroidism
100%
80%
60%
40%
20%
0%
Study treatment Arm
Relugolix Plus E2/NETA (Group A)
Relugolix Plus Delayed E2/NETA (Group B)
Placebo (Group C)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A: RelugolixExperimental Treatment1 Intervention
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.
Group II: Arm B: LeuprolideActive Control1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Relugolix
2016
Completed Phase 3
~5360

Find a Location

Who is running the clinical trial?

Dana-Farber Cancer InstituteLead Sponsor
1,079 Previous Clinical Trials
340,838 Total Patients Enrolled
76 Trials studying Prostate Cancer
15,995 Patients Enrolled for Prostate Cancer
Prostate Cancer FoundationOTHER
47 Previous Clinical Trials
2,670 Total Patients Enrolled
27 Trials studying Prostate Cancer
1,820 Patients Enrolled for Prostate Cancer
PfizerIndustry Sponsor
4,567 Previous Clinical Trials
10,911,764 Total Patients Enrolled
41 Trials studying Prostate Cancer
12,259 Patients Enrolled for Prostate Cancer

Media Library

Leuprolide (GnRH Agonist) Clinical Trial Eligibility Overview. Trial Name: NCT05765500 — Phase 2
Prostate Cancer Research Study Groups: Arm B: Leuprolide, Arm A: Relugolix
Prostate Cancer Clinical Trial 2023: Leuprolide Highlights & Side Effects. Trial Name: NCT05765500 — Phase 2
Leuprolide (GnRH Agonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05765500 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the FDA sanctioned Relugolix for pharmaceutical use?

"With clinical data confirming a certain level of safety and the lack of evidence suggesting efficacy, Arm A: Relugolix received a score of 2."

Answered by AI

Is there still availability for participation in this research endeavor?

"The information displayed on clinicaltrials.gov reveals that this medical study is not presently seeking applicants, however it was initially published on August 1st 2023 and last updated March 1st of the same year. Although no longer recruiting patients, there are 1318 other trials currently enrolling participants."

Answered by AI
~73 spots leftby Jul 2025