Clinical trial · Interventional
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Leuprolide Acetate | Drug | Leuprolide | ALIAS |
| Relugolix | Drug | Relugolix | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Relugolix
- description
- Oral relugolix 120 mg once daily with a loading dose of 360 mg on Day 1
- interventionNames
- Drug: Relugolix
- type
- ACTIVE_COMPARATOR
- label
- Leuprolide Acetate
- description
- Subcutaneous or intramuscular leuprolide acetate 22.5 mg 3-M depot or 45 mg 6-M injection or Leuprolide acetate injectable emulsion (42 mg injectable emulsion is not allowed)
- interventionNames
- Drug: Leuprolide Acetate
Primary outcomes (1)
- measure
- Number of Patients With Adverse Events and Serious Adverse Events
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
A patient will be eligible for inclusion in the discontinuation phase of the study if the following applies: 1. Was previously enrolled under the original version and amendment 1 of this study 2. Has voluntarily resigned and dated the informed consent form prior to transition to the discontinuation phase of this study
References
Publications (0)
Data not yet available