RElugolix VErsus LeUprolide Cardiac Trial

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT05320406
Phase
PHASE2
Status
Active Not Recruiting

Conditions

  • Biochemically Recurrent Prostate Carcinoma
  • Localized Prostate Carcinoma
  • Stage I Prostate Cancer AJCC v8
  • Stage II Prostate Cancer AJCC v8
  • Stage IIA Prostate Cancer AJCC v8
  • Stage IIB Prostate Cancer AJCC v8
  • Stage IIC Prostate Cancer AJCC v8
  • Stage III Prostate Cancer AJCC v8
  • Stage IIIA Prostate Cancer AJCC v8
  • Stage IIIB Prostate Cancer AJCC v8
  • Stage IIIC Prostate Cancer AJCC v8

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Radiation therapy — RADIATION
    Undergo radiation therapy
  • Leuprolide — DRUG
    Given IM or SC
  • Relugolix — DRUG
    Given PO

Study Details

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.

Key Dates

Start date
Jun 6, 2022
Status verified
Jan 2026
Primary completion
Jan 30, 2025
Completion
Oct 30, 2026

Study Design

Enrollment
94 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Arm I (radiation therapy alone)
    Patients undergo definitive radiation therapy alone (IMRT, SBRT, proton therapy, brachytherapy) in the absence of disease progression or unacceptable toxicity.
  • Experimental: Arm II (radiation therapy plus leuprolide)
    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.
  • Experimental: Arm III (radiation therapy plus relugolix)
    Patients undergo radiation therapy as in Arm I and receive relugolix PO QD. Treatment continues for 6 to 12 months (depending on risk) in the absence of disease progression or unacceptable toxicity.

Primary Outcome Measure

Total Coronary Plaque Volume in Major Coronary Arteries (i.e. Left Anterior Descending, Left Circumflex, Right Major Coronary Arteries) [ Time Frame: From baseline to 12 months post-treatment initiation ]

Locations (4)

FacilityCityStateZIPSite coordinators
Emory Proton Therapy CenterAtlantaGeorgia30308-
Emory Saint Joseph's HospitalAtlantaGeorgia30342-
Emory University Hospital MidtownAtlantaGeorgia30308-
Emory University/Winship Cancer InstituteAtlantaGeorgia30322-

Related coverage on Hipa.ai

Find similar trials in Atlanta, GA

By research site
Emory Proton Therapy Center· Atlanta, GAEmory Saint Joseph's Hospital· Atlanta, GAEmory University Hospital Midtown· Atlanta, GAEmory University/Winship Cancer Institute· Atlanta, GA

Related Studies