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NCT05320406 · ClinicalTrials.gov registry record · Phase 2
RElugolix VErsus LeUprolide Cardiac Trial
A Phase 2 study of Stage III Prostate Cancer AJCC v8 and Stage II Prostate Cancer AJCC v8, sponsored by Emory University.
- Active
- Registry status
- Phase 2
- Development phase
- 94
- Enrollment target
- 4
- Study locations
NCT05320406: Active Phase 2 study of Stage III Prostate Cancer AJCC v8 and Stage II Prostate Cancer AJCC v8, sponsored by Emory University.
NCT05320406 is a Phase 2 study of Stage III Prostate Cancer AJCC v8 and Stage II Prostate Cancer AJCC v8 that is active but no longer recruiting, run by Emory University. The registered enrollment target is 94 participants, below the 246-participant average among 28 other Stage III Prostate Cancer AJCC v8 trials with a reported enrollment target (62% lower). The trial reports 4 study locations across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05320406, a Phase 2 study of Stage III Prostate Cancer AJCC v8 and Stage II Prostate Cancer AJCC v8, is active but no longer recruiting, sponsored by Emory University.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 94 participants
- Enrollment target
- 4
- Study locations
Study Summary
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.
Primary Outcome
Using cardiac computed tomography angiography (CCTA), total coronary plaque volume will be determined using an artificial intelligence-enabled quantitative coronary plaque analysis (AI-QCPA) through a commercially available and validated software service (HeartFlow, Inc). Each coronary artery (right coronary, left main, left anterior descending, and left circumflex) will be scored, and plaque volumes were summed over all segments.
Conditions Studied
Interventions
- DRUG Relugolix
- RADIATION Radiation therapy
- DRUG Leuprolide
Study Locations (4)
Georgia
- Emory Proton Therapy Center - Atlanta
- Emory University Hospital Midtown - Atlanta
- Emory University/Winship Cancer Institute - Atlanta
- Emory Saint Joseph's Hospital - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 94 participants |
| Start Date | 2022-06-06 |
| Est. Completion | 2026-10-30 |
| Phase | Phase 2 |
What the registry record for NCT05320406 still lists
NCT05320406 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 94 participants, a relatively small participant target, below the 246-participant average among 28 other Stage III Prostate Cancer AJCC v8 trials with a reported enrollment target (62% lower).
The record links to 10 conditions, with Stage III Prostate Cancer AJCC v8 appearing as the primary indexed condition, and to 3 interventions - of which Relugolix is the first listed.
NCT05320406 reports a single indexed study location in Georgia.
Frequently Asked Questions
What is clinical trial NCT05320406 about?
NCT05320406 is a clinical study titled "RElugolix VErsus LeUprolide Cardiac Trial". 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 ...
What is the current status of trial NCT05320406?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 94 participants. The study started on 2022-06-06. Estimated completion is 2026-10-30.
What conditions does trial NCT05320406 study?
This clinical trial studies the following conditions: Stage III Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage I Prostate Cancer AJCC v8, Stage IIC Prostate Cancer AJCC v8, Localized Prostate Carcinoma.
What interventions are being tested in trial NCT05320406?
The interventions under investigation include: Relugolix (DRUG), Radiation therapy (RADIATION), Leuprolide (DRUG).
Who is sponsoring clinical trial NCT05320406?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05320406 being conducted?
This trial has 4 study locations across Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Stage III Prostate Cancer AJCC v8
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05320406's enrollment target sits among peer trials
94 14th of 28 higher than 15 of 28 other Stage III Prostate Cancer AJCC v8 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Stage III Prostate Cancer AJCC v8 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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