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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05320406
The ClinicalTrials.gov registry entry for NCT05320406 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 94 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 246-participant average among 28 other Stage III Prostate Cancer AJCC v8 trials with a reported enrollment target (62% lower). The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
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 4 study locations spanning 1 distinct geographic area - top geographies include 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.
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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.