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Hormone Therapy
Relugolix vs Leuprolide for Prostate Cancer (REPLACE-CV Trial)
Phase 3
Waitlist Available
Research Sponsored by Myovant Sciences GmbH
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 from date of enrollment until date of first confirmed mace, assessed up to 5 years
Awards & highlights
REPLACE-CV Trial Summary
This trial will compare the risk of major heart events in prostate cancer patients taking Relugolix or Leuprolide Acetate. Ages 18+. On ADT for min. 1 year.
Who is the study for?
Men over 18 with prostate cancer who need androgen deprivation therapy for at least a year can join. They should have a history of cardiovascular disease or multiple risk factors like being over 55, hypertension, high cholesterol, smoking, or family history of heart disease. Excluded are those with recent significant heart issues, uncontrolled blood pressure, long-term hormone treatments for prostate cancer (>18 months), brain metastases, or other active cancers.Check my eligibility
What is being tested?
The trial is testing the safety of two prostate cancer treatments: Relugolix and Leuprolide Acetate. It focuses on their effects on major cardiovascular events in patients receiving these drugs as part of their treatment plan.See study design
What are the potential side effects?
Possible side effects include hot flashes, fatigue, diarrhea, constipation and joint pain. Both medications may also affect liver enzymes and testosterone levels which could lead to changes in mood or sexual function.
REPLACE-CV Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from date of enrollment until date of first confirmed mace, assessed up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from date of enrollment until date of first confirmed mace, assessed up to 5 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Time to Major Adverse Cardiovascular Event (MACE)
Secondary outcome measures
Incidence of Safety Outcomes
Time Course of Events Related to MACE
Side 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)
REPLACE-CV Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: RelugolixExperimental Treatment1 Intervention
Oral relugolix 120 mg once daily with a loading dose of 360 mg on Day 1
Group II: Leuprolide AcetateActive Control1 Intervention
Subcutaneous or intramuscular leuprolide acetate 22.5 mg 3-M depot or 45 mg 6-M injection or Leuprolide acetate injectable emulsion (42 mg injectable emulsion is not allowed)
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?
Myovant Sciences GmbHLead Sponsor
22 Previous Clinical Trials
10,240 Total Patients Enrolled
5 Trials studying Prostate Cancer
2,394 Patients Enrolled for Prostate Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My doctor plans to change my hormone therapy drugs during the study.I am eligible for both treatments offered in the study.I can think clearly enough to answer questions and participate in study activities.I am a man aged 18 or older.I haven't had any major heart problems in the last month.My blood pressure is not controlled with medication.I have been treated with hormone therapy for my cancer.I have prostate cancer and no other active cancers, except for certain allowed types.My prostate cancer diagnosis was confirmed through lab tests.My testosterone level was above 150 ng/dL within the last 6 months.I do not have any major heart or brain procedures planned within a month after joining.I have high-risk heart disease or at least 3 heart disease risk factors.My doctor thinks I should have hormone therapy for prostate cancer for at least 12 months.
Research Study Groups:
This trial has the following groups:- Group 1: Relugolix
- Group 2: Leuprolide Acetate
Awards:
This trial has 2 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- 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.
Are there a variety of sites executing this investigation across the state?
"Five medical centres are currently enrolling patients for this trial, including Florida Urology Partners, LLP in Tampa and Potomac Urology Center, PC in Alexandria. Additionally, Arizona Urology Specialists, PLLC is located in Tucson with 5 other locations taking part as well."
Answered by AI
Is enrollment into this trial available to patients at the present time?
"Confirmed. The information on clinicaltrials.gov suggests that this trial is no longer recruiting participants; however, there are over 1300 other trials currently enrolling patients. This particular study was posted December 1st of 2022 and the most recent update occurred a week later on December 7th."
Answered by AI
What is the risk profile associated with Relugolix administration?
"Our experts at Power assigned Relugolix a score of 3 in regards to safety, taking into consideration the available evidence from Phase 3 trials. These studies have provided both efficacy and numerous data points affirming its safeguarding properties."
Answered by AI
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