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Clinical trialNCT05320406Active, not recruitingPhase 2Interventional

RElugolix VErsus LeUprolide Cardiac Trial

SponsorEmory UniversityEnrollment94Biochemically Recurrent Prostate CarcinomaLocalized Prostate CarcinomaStage I Prostate Cancer AJCC v8Stage II Prostate Cancer AJCC v8Stage IIA Prostate Cancer AJCC v8Stage IIB Prostate Cancer AJCC v8+5 more conditions
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

  • Sagar A Patel, MD

    Emory University Hospital/Winship Cancer Institute

    Principal Investigator

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

4 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Emory Proton Therapy Center

    Atlanta, Georgia, United States

  • Emory Saint Joseph'S Hospital

    Atlanta, Georgia, United States

  • Emory University Hospital Midtown

    Atlanta, Georgia, United States

  • Emory University/winship Cancer Institute

    Atlanta, Georgia, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
6 Jun 2022
Primary completion
30 Jan 2025
Completion
30 Oct 2026
Last update posted
12 Feb 2026
Registered enrollment
94
Registry id
NCT05320406

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 4 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.