Randomized Study to Evaluate MACE in Patients With Prostate Cancer Treated With Relugolix or Leuprolide Acetate
Completed · Phase 3
Conditions studied: Prostate Cancer
In brief
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.
Key facts
- Study ID
- NCT05605964
- Run by
- Sumitomo Pharma America, Inc.
- People needed
- 387
- Starts
- 2023-01-28
- Expected to finish
- 2024-12-31
- Last updated by the study team
- 2026-06-15
Who can join
Age: 18 and older. Sex: male. Healthy volunteers: not accepted.
Where it is running
- Arizona Urology Specialists, PLLC — Tucson, Arizona, United States
- Arkansas Urology — Little Rock, Arkansas, United States
- Genesis Research, LLC Satellite — Downey, California, United States
- Orange Coast Memorial Medical Center — Fountain Valley, California, United States
- Genesis Research , LLC — Los Alamitos, California, United States
- Tower Urology — Los Angeles, California, United States
- Pacific Cancer Care — Monterey, California, United States
- Tri Valley Urology Medical Group — Murrieta, California, United States
- Tri Valley Urology Medical Group Satellite — Murrieta, California, United States
- San Bernadino Urological Associates Medical Group — San Bernardino, California, United States
- Genesis Research, LLC — San Diego, California, United States
- Genesis Research, LLC Satellite — Sherman Oaks, California, United States
- Tri Valley Urology Medical Group Satellite — Temecula, California, United States
- Genesis Research, LLC Satellite — Torrance, California, United States
- Genesis Research, LLC Satellite — Torrance, California, United States
- Medstar Washington Hospital Center — Washington D.C., District of Columbia, United States
- Urologic Surgeons of Washington — Washington D.C., District of Columbia, United States
- Advanced Urology Institute — Daytona Beach, Florida, United States
- East Coast Institute for Research, LLC Satellite — Jacksonville, Florida, United States
- East Coast Institute for Research, LLC — Jacksonville, Florida, United States
- East Coast Institute for Research, LLC Satellite — Jacksonville, Florida, United States
- Lake City Cancer Center, LLC — Lake City, Florida, United States
- SG Research LLC — Miami, Florida, United States
- Florida Urology Partners, LLP Satellite — Tampa, Florida, United States
- Urology Associates of Mobile — Mobile, Alabama, United States
Full record on ClinicalTrials.gov
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