Randomized Study to Evaluate MACE in Patients With Prostate Cancer Treated With Relugolix or Leuprolide Acetate
Completed · Phase 3 · NCT05605964
Conditions: Prostate Cancer
At a glance
- Research payments reported, 2025
- $475,186
- U.S. investigators named
- 43
- Sites paid
- 42
- Planned or actual enrollment
- 387
About the trial
- Sponsor
- Sumitomo Pharma America, Inc.
- Tested
- Relugolix (drug), Leuprolide Acetate (drug)
- Dates
- Started 2023-01-28; completion 2024-12-31
- Results posted
- Yes
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.
From ClinicalTrials.gov, last updated 2026-06-15. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Sumitomo Pharma America, Inc. reported $475,186 in research payments for this study in 2025 (144 payments).
Products named: Orgovyx
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Charles F. White JR., M.D. Urology · Mobile, AL
- John C. Henderson, MD Internal Medicine · Searcy, AR
- Curtis J. Dunshee, MD Urology · Tucson, AZ
- Philip P. Brodak, MD Urology · Murrieta, CA
- Franklin M. Chu, MD Urology · San Bernardino, CA
- Sepehr Nowfar, M.D. Urology · Whittier, CA
- Amol R. Rao, M.D. Hematology & Oncology · Fountain Valley, CA
- Jason D. Engel, M.D., Urology · Washington, DC
- George K. Philips, MBBS, MD, MPH Hematology & Oncology · Washington, DC
- Evan Fynes, M.D. Urology · Daytona Beach, FL
- Osvaldo F. Padron, M.D. Specialist · Tampa, FL
- Avirup Guha, M.B.B.S. Cardiology · Augusta, GA
- Stephen A. Brassell, MD Urology · Boise, ID
- Gregory J. Andros, M.D. Urology · Joliet, IL
- Aaron D. Berger, M.D. Urology · Chicago Ridge, IL
- Gary R. Macvicar, MD Hematology & Oncology · Peoria, IL
- Ashley E. Ross Urology · Chicago, IL
- Daniel H. Shevrin, MD Medical Oncology · Evanston, IL
- Eugene B. Cone, M.D. Urology · Greenwood, IN
- Adam J. Gadzinski, M.D. Urology · Royal Oak, MI
- Jason M. Hafron, MD Urology · West Bloomfield, MI
- Gregory B. Auffenberg, M.D., M.S. Urology · Saint Louis, MO
- Reed E. Cope, MD Radiation Oncology · Columbia, MO
- Andrew F. Trainer, M.D. Urology · Omaha, NE
- Robert S. Alter, MD Medical Oncology · Hackensack, NJ
- Eric Mayer, M.D. Urology · Pennington, NJ
- Neda Hashemi Sadraei, M.D. Hematology & Oncology · Albuquerque, NM
- Christopher M. Pieczonka, M.D. Urology · Syracuse, NY
- Lawrence A. Gervasi, MD Urology · Middleburg Heights, OH
- Benjamin J. Martin, MD Urology · Gahanna, OH
- Marc J. Pliskin, DO Urology · Cincinnati, OH
- Laurence H. Belkoff, D.O. Urology · Bala Cynwyd, PA
- Paul R. Sieber, M.D. Urology · Lancaster, PA
- Neal Shore, DR Urology · Myrtle Beach, SC
- David S. Morris, MD Urology · Hendersonville, TN
- Francisco J. Gelpi-hammerschmidt, M.D. Urology · Houston, TX
- Naveen Kella, M.D. Urology · San Antonio, TX
- Brandon M. Barney, M.D. Radiation Oncology · American Fork, UT
- Nilay Gandhi, MD Urology · Woodbridge, VA
- Robert W. Given, M.D. Urology · Virginia Beach, VA
- Eugene V. Kramolowsky II, M.D. Urology · Richmond, VA
- Asit K. Paul, M.D., PH.D., Hematology & Oncology · Richmond, VA
- Carl J. Walker, MD Urology · Spokane, WA
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Intermountain Health Mckay-Dee Hospital, UT $41,900
- Potomac Urology Center PC $38,665
- Arizona Urology Specialists PLLC $30,598
- Augusta University Research Institute Inc $25,390
- Advanced Urology Institute $21,356
- Uropartners LLC $20,568
- Genesis Research LLC $19,470
- Urologic Surgeons of Washington Chartered $19,440
- Tristate Urologic Services Psc Inc DBA the Urology $19,371
- Northwestern University $18,278
- Medstar Health Research Institute $17,424
- Hackensack University Medical Center, NJ $17,190
- New Mexico Cancer Research Alliance $14,254
- Virginia Commonwealth University $13,000
- Helios Clinical Research Inc $13,000
- The Urology Place $12,839
- Hmu Crc LLC $12,662
- Michigan Institute of Urology PC $11,636
- Carolina Urologic Research Center LLC $11,061
- Centers for Advanced Urology LLP DBA Midlantic $10,594
- Tri-Valley Urology Medical Group Philip Brodak Eta $10,242
- Associated Medical Professionals of Ny PLLC $8,063
- Urology Associates of Mobile PA $7,267
- Urology Associates PC $7,198
- Central Ohio Urology Group $6,700
- Urology of Virginia PLLC $5,375
- Gulf Coast Clinical Trial Associates $5,071
- St Luke's Regional Medical Center, ID $5,000
- Specialty Clinical Research of St Louis LLC $4,490
- Adult & Pediatric Urology PC $4,166
- Medatlantic Inc $3,620
- Northshore University Healthsystem - Evanston Hospital, IL $3,178
- Lake Regional Health System $3,051
- Urology of Indiana LLC $2,569
- Spokane Urology Ps $2,500
- Capital Health Regional Medical Center, NJ $2,500
- Lancaster Urology PC DBA Keystone Urology Special $2,500
- Michigan Healthcare Professions PC DBA Comprehens $1,851
- Oncology Hematology Assoc of Central Il PC DBA I $579
- Franklin Chu Inc DBA San Bernardino Urological A $330
- Arkansas Urology Research Center LLC $150
- Memorial Health Services DBA Memorialcare $90
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.