Relugolix vs Leuprolide for Prostate Cancer
(REPLACE-CV Trial)
Trial Summary
Do I need to stop my current medications for this trial?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the drug Relugolix compared to Leuprolide for prostate cancer?
Is Relugolix safe compared to Leuprolide for prostate cancer treatment?
How does the drug Relugolix differ from Leuprolide in treating prostate cancer?
Relugolix is unique because it is an oral medication that provides rapid testosterone suppression without an initial surge, unlike Leuprolide, which is given as an injection. Additionally, Relugolix has been shown to reduce the risk of major adverse cardiovascular events compared to Leuprolide.14578
What is the purpose of this trial?
This trial compared the safety and heart-related risks of two hormone-lowering medications, relugolix and leuprolide acetate, in adults with prostate cancer. These drugs help manage cancer by reducing testosterone levels. The study was discontinued, but patients can continue their treatment for a certain period. Relugolix is the first oral medication of its kind and was approved by the FDA based on previous study results.
Eligibility Criteria
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.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either relugolix or leuprolide acetate for prostate cancer treatment
Discontinuation Phase
Actively enrolled patients may remain on study drug up to a period of 12 months ending Dec 2024
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Leuprolide Acetate
- Relugolix
Leuprolide Acetate is already approved in United States, European Union, Canada, Japan for the following indications:
- Prostate cancer
- Endometriosis
- Uterine fibroids
- Precocious puberty
- Prostate cancer
- Endometriosis
- Uterine fibroids
- Precocious puberty
- Prostate cancer
- Endometriosis
- Uterine fibroids
- Precocious puberty
- Prostate cancer
- Endometriosis
- Uterine fibroids
- Precocious puberty
Find a Clinic Near You
Who Is Running the Clinical Trial?
Sumitomo Pharma Switzerland GmbH
Lead Sponsor
Myovant Sciences GmbH
Lead Sponsor