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Trial · Interventional

Active, not recruitingPhase 2Results postedRegistry data

RElugolix VErsus LeUprolide Cardiac Trial

Short name REVELUTION

NCTNCT05320406 (opens ClinicalTrials.gov in a new tab)Other idSTUDY00003654Other idNCI-2022-00117Other idSTUDY00003654Other idRAD5484-21
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Active, not recruiting
Phase
Phase 2
Enrollment
94 participants (actual)
Sponsor
Emory University · Other
Design
Randomized · Single masking
Countries
1 country

United States

Start
6 Jun 2022
Primary completion
30 Jan 2025
Completion
30 Oct 2026 (estimated)
First posted
11 Apr 2022
Last update posted
12 Feb 2026
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

Timeline

1 trial · 1 ongoing · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
202220232024202520262027
  1. Ph 2

    REVELUTION

    NCT05320406

    6 Jun 2022 to est. 30 Oct 2026

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown 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.

Interventions

  • Radiation therapyRadiation
  • LeuprolideDrug
  • RelugolixDrug

Arms3

  • 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 outcomes1

Outcomes the sponsor listed as primary.

  1. 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

    Registry description

    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.

Secondary outcomes(1)

  1. Non-calcified 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

    Registry description

    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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeMedian· From baseline to 12 months post-treatment initiation

Total Coronary Plaque Volume in Major Coronary Arteries (i.e. Left Anterior Descending, Left Circumflex, Right Major Coronary Arteries)

GroupValue (mm3)
Arm I (Radiation Therapy Alone)103.0
Arm II (Radiation Therapy Plus Leuprolide)204.0
Arm III (Radiation Therapy Plus Relugolix)272.0
Secondary and other outcome results(6)
Secondary outcomeMedian· From baseline to 12 months post-treatment initiation

Non-calcified Coronary Plaque Volume in Major Coronary Arteries (i.e. Left Anterior Descending, Left Circumflex, Right Major Coronary Arteries)

GroupValue (mm3)
Arm I (Radiation Therapy Alone)98.0
Arm II (Radiation Therapy Plus Leuprolide)157.0
Arm III (Radiation Therapy Plus Relugolix)206.0
Other pre specified outcomeMedian· From baseline to 12 months post-treatment initiation

Calcified and Low-attenuation Coronary Plaque Volume in Major Coronary Arteries (i.e. Left Anterior Descending, Left Circumflex, Right Major Coronary Arteries)

GroupValue (mm3)
Arm I (Radiation Therapy Alone)11.5
Arm II (Radiation Therapy Plus Leuprolide)34.0
Arm III (Radiation Therapy Plus Relugolix)41.0
Other pre specified outcomeMedian· From baseline to 12 months post-treatment initiation

Coronary Artery Calcium Score (CACS)

GroupValue (Agatston score (range 0-400))
Arm I (Radiation Therapy Alone)24.9
Arm II (Radiation Therapy Plus Leuprolide)106.6
Arm III (Radiation Therapy Plus Relugolix)96.0
Other pre specified outcomeCount of participants· From baseline to 12 months post-treatment initiation

Number of Participants With <30%, 30-49%, 50-69%, and >70% Maximum Coronary Vessel Stenosis at Baseline and Month 12

GroupValue (Participants)
Arm I (Radiation Therapy Alone)5
Arm II (Radiation Therapy Plus Leuprolide)3
Arm III (Radiation Therapy Plus Relugolix)4
Other pre specified outcomeCount of participants· From baseline to at least 2 years post-treatment initiation

Major Adverse Cardiovascular Events

GroupValue (Participants)
Arm I (Radiation Therapy Alone)1
Arm II (Radiation Therapy Plus Leuprolide)3
Arm III (Radiation Therapy Plus Relugolix)0
Other pre specified outcomeMean· Baseline and month 0, 3, 6, 12

Testosterone Kinetics

GroupValue (ng/mL)Spread
Arm I (Radiation Therapy Alone)254.43316.365
Arm II (Radiation Therapy Plus Leuprolide)292.73515.114
Arm III (Radiation Therapy Plus Relugolix)254.54815.828

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
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. Radiation therapy: Undergo radiation therapy0 / 280 / 2823 / 28
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. Radiation therapy: Undergo radiation therapy Leuprolide: Given IM or SC1 / 311 / 3127 / 31
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. Radiation therapy: Undergo radiation therapy Relugolix: Given PO0 / 310 / 3130 / 31

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies1

Studies that cite this trial.

More studies

1 study on this page

Indexing hint: Randomized controlled trial · 2026

Corrected

Coronary Plaque Progression After Androgen Deprivation Therapy in Men With Prostate Cancer: A Randomized Clinical Trial.

Patel et al. 2026JAMA cardiologycited by 5

PMID 41706486PMC12917740DOI 10.1001/jamacardio.2025.5586PUB-41706486

Free to read · publisher termsCC BY-NC-ND
Read at sourceRead the notice

Eligibility

Who could join, as posted.

Sex
Male
Age
from 18 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
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

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