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NCT05605964 · ClinicalTrials.gov registry record · Phase 3
Randomized Study to Evaluate MACE in Patients With Prostate Cancer Treated With Relugolix or Leuprolide Acetate
A Phase 3 study of Prostate Cancer, sponsored by Sumitomo Pharma America.
- Completed
- Registry status
- Phase 3
- Development phase
- 387
- Enrollment target
- 20
- Study locations
NCT05605964: Completed Phase 3 study of Prostate Cancer, sponsored by Sumitomo Pharma America.
NCT05605964 is a Phase 3 study of Prostate Cancer that has completed, run by Sumitomo Pharma America. The registered enrollment target is 387 participants, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (36% lower). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05605964, a Phase 3 study of Prostate Cancer, has completed, sponsored by Sumitomo Pharma America.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 387 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Number of patients with adverse events and serious adverse events
Conditions Studied
Interventions
- DRUG Relugolix
- DRUG Leuprolide Acetate
Study Locations (20)
California
- Genesis Research, LLC Satellite - Downey
- Orange Coast Memorial Medical Center - Fountain Valley
- Genesis Research , LLC - Los Alamitos
- Tower Urology - Los Angeles
- Pacific Cancer Care - Monterey
- Tri Valley Urology Medical Group - Murrieta
- Tri Valley Urology Medical Group Satellite - Murrieta
- San Bernadino Urological Associates Medical Group - San Bernardino
- Genesis Research, LLC - San Diego
- Genesis Research, LLC Satellite - Sherman Oaks
- Tri Valley Urology Medical Group Satellite - Temecula
- Genesis Research, LLC Satellite - Torrance
- Genesis Research, LLC Satellite - Torrance
District of Columbia
- Medstar Washington Hospital Center - Washington D.C.
- Urologic Surgeons of Washington - Washington D.C.
Florida
- Advanced Urology Institute - Daytona Beach
- East Coast Institute for Research, LLC Satellite - Jacksonville
Alabama
- Urology Associates of Mobile - Mobile
Arizona
- Arizona Urology Specialists, PLLC - Tucson
Arkansas
- Arkansas Urology - Little Rock
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 387 participants |
| Start Date | 2023-01-25 |
| Est. Completion | 2025-01-02 |
| Phase | Phase 3 |
What the finished NCT05605964 record still lists
NCT05605964 is an interventional study that assigns participants to a tested intervention. The registered 387 participants enrollment target is mid-sized for trials with a published cap, below the 608-participant average among 735 other Prostate Cancer trials with a reported enrollment target (36% lower).
The record links to 1 condition, with Prostate Cancer appearing as the primary indexed condition, and to 2 interventions - of which Relugolix is the first listed.
NCT05605964 names 20 study sites across 6 states, led by California, District of Columbia, Florida.
Frequently Asked Questions
What is clinical trial NCT05605964 about?
NCT05605964 is a clinical study titled "Randomized Study to Evaluate MACE in Patients With Prostate Cancer Treated With Relugolix or Leuprolide Acetate". 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 wil...
What is the current status of trial NCT05605964?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 387 participants. The study started on 2023-01-25. Estimated completion is 2025-01-02.
What conditions does trial NCT05605964 study?
This clinical trial studies the following conditions: Prostate Cancer.
What interventions are being tested in trial NCT05605964?
The interventions under investigation include: Relugolix (DRUG), Leuprolide Acetate (DRUG).
Who is sponsoring clinical trial NCT05605964?
This trial is sponsored by Sumitomo Pharma America, which has 168 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05605964 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05605964's enrollment target sits among peer trials
387 138th of 735 higher than 598 of 735 other Prostate Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Prostate Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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