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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
Be older than 18 years old
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.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 9 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 9 months
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 moreSide effects data
From 2020 Phase 3 trial • 388 Patients • NCT0304973511%
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
340,871 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
4,570 Previous Clinical Trials
10,915,876 Total Patients Enrolled
41 Trials studying Prostate Cancer
12,260 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have another cancer, but it doesn't affect my current treatment's safety or effectiveness.I am allergic to medications similar to leuprolide or relugolix.My cancer has spread to my brain.I do not have any uncontrolled illnesses.I am receiving or planning to receive advanced hormone therapy for cancer.I am 18 years old or older.I have had a serious heart problem in the last 6 months.I have never been treated with GnRH therapies.My blood counts and liver/kidney functions are within normal ranges.My heart condition does not severely limit my daily activities.I am HIV-positive, on treatment, and my viral load is undetectable.I cannot swallow pills.I can take care of myself but might not be able to do heavy physical work.I agree to use effective birth control during the study.I have chronic HBV but it's under control with treatment.I can be treated with hormone therapy for 6 months without other systemic treatments.I had hepatitis C but am now cured or have no detectable virus while on treatment.My cancer is diagnosed as prostate adenocarcinoma.
Research Study Groups:
This trial has the following groups:- Group 1: Arm B: Leuprolide
- Group 2: Arm A: Relugolix
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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
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