NCT05605964

Randomized Study to Evaluate MACE in Patients With Prostate Cancer Treated With Relugolix or Leuprolide Acetate

Relugolix Versus Leuprolide in Patients With Prostate Cancer: A Randomized, Open-Label Study to Assess Major Adverse Cardiovascular Events (REPLACE-CV)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 387 (actual)
• Sponsor: Sumitomo Pharma America, Inc. · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This was a randomized study to evaluate the risk of major adverse cardiovascular events (MACE) for relugolix compared with leuprolide acetate. Enrollment in this study was discontinued by the Sponsor on 01 Dec 2023. In an effort to mitigate any treatment interruptions, actively enrolled patients will be allowed to remain on study drug up to a period of 12 months ending Dec 2024 if they choose to remain in the discontinuation phase of the study.

Detailed description

Eligible patients were randomized (1:1) to receive either relugolix or leuprolide acetate for prostate cancer or as an adjunct to primary or salvage radiation therapy. The study was intended to collect clinical and cardiovascular risk factor data on patients ages 18 and older who were receiving relugolix or leuprolide acetate for their prostate cancer or as adjunct to radiation therapy with a treatment plan to be on at least 12 months of continuous ADT. Enrollment in this study was discontinued by the Sponsor on 04 Dec 2023. In an effort to mitigate any treatment interruptions, actively enrolled patients will be allowed to remain on study drug up to a period of 12 months ending Dec 2024. During this discontinuation phase, all active investigative sites will be expected to formulate a transition plan for their study patients from this clinical study to SOC as soon as practicable. The primary endpoint in this study was the time to first adjudicated MACE (nonfatal myocardial infarction, nonfatal stroke, and cardiovascular death). However, with the discontinuation of enrollment in the study on 04 DEC 2023 by the sponsor, the primary endpoint will be to describe the safety of relugolix in the study population while actively enrolled patients remain on study drug.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
DRUG	Relugolix	Relugolix tablet
DRUG	Leuprolide Acetate	Leuprolide acetate injection

Timeline

• Start date: 2023-01-25
• Primary completion: 2025-01-02
• Completion: 2025-01-02
• First posted: 2022-11-04
• Last updated: 2025-08-17

Locations

108 sites across 1 country: United States

Regulatory

• FDA-regulated drug study