Clinical trial · Interventional
RElugolix VErsus LeUprolide Cardiac Trial
Mechanism and Predictors of Cardiotoxicity After Prostate Cancer Treatment: A Parallel Cohort and Randomized Trial Comparing Radiation Alone, Radiation Plus Leuprolide, and Radiation Plus Relugolix
- 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 clinical trial investigates the impact of prostate cancer treatment, specifically androgen deprivation therapy (ADT), on the heart and coronary vessels among men with localized, non-metastatic prostate cancer undergoing definitive radiation therapy and concomitant ADT. Recently, cardiovascular toxicity from hormone therapy that is routinely used for prostate cancer (e.g. leuprolide) has emerged as a concern, yet studies identifying who is at risk and the mechanism of cardiac damage are lacking. Additionally, a new hormone therapy drug, relugolix, has recently been Food and Drug Administration (FDA)-approved and may reduce toxicity to the heart. This trial intends to investigate the mechanism of cardiovascular toxicity from ADT, investigate the mechanism by which relugolix reduces cardiovascular toxicity, and identify predictive biomarkers to improve individualized risk-assessment for cardiovascular toxicity from ADT.
Conditions
Conditions (11)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biochemically Recurrent Prostate Carcinoma | — | UNRESOLVED | — |
| Localized Prostate Carcinoma | Prostate Carcinoma | CURATED_BROADER | 0.78 |
| Stage IIA Prostate Cancer AJCC v8 | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIB Prostate Cancer AJCC v8 | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIC Prostate Cancer AJCC v8 | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIA Prostate Cancer AJCC v8 | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage IIIB Prostate Cancer AJCC v8 | Malignant Prostate Neoplasm | CURATED_BROADER |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Leuprolide | Drug | Leuprolide | ALIAS |
| Radiation therapy | Radiation | — | UNRESOLVED |
| Relugolix | Drug | Relugolix | ALIAS |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Arm I (radiation therapy alone)
- description
- Patients undergo definitive radiation therapy alone (IMRT, SBRT, proton therapy, brachytherapy) in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Radiation: Radiation therapy
- type
- EXPERIMENTAL
- label
- Arm II (radiation therapy plus leuprolide)
- description
- Patients undergo radiation therapy as in Arm I and receive leuprolide SC or IM every 3 or 6 months. Treatment continues for 6 to 12 months (depending on risk) in the absence of disease progression or unacceptable toxicity.
- interventionNames
- Radiation: Radiation therapy
- Drug: Leuprolide
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Men \>= 18 years old * Non-metastatic prostate cancer * Non-metastatic, biochemically recurrent prostate cancer * Plan to undergo curative-intent pelvic radiation therapy with or without ADT Exclusion Criteria: * Metastatic prostate cancer requiring \> 24 months of ADT * Prior exposure to androgen deprivation therapy * Prior exposure to chemotherapy or immunotherapy * History of cardiac bypass surgery or percutaneous coronary intervention
References
Publications (1)
- DERIVEDPatel SA, Yadalam AK, van Assen M, Cantu SM, Onnis C, Zheng B, Koo A, Goyal S, Liu Y, Liu C, Sebastian NT, Dhere VR, Hershatter BW, Patel PR, Chaudagar K, Stillman AE, De Cecco CN, Sanda MG, Jani AB, Mandawat A. Coronary Plaque Progression After Androgen Deprivation Therapy in Men With Prostate Cancer: A Randomized Clinical Trial. JAMA Cardiol. 2026 May 1;11(5):459-463. doi: 10.1001/jamacardio.2025.5586. PMID 41706486