Relugolix vs Leuprolide for Prostate Cancer (REVELUTION Trial)

Palo Alto (17 mi)

Overseen bySagar A. Patel, MD

Age: 18+

Sex: Male

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: Emory University

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This phase IV 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.

Eligibility Criteria

This trial is for men aged 18 or older with localized, non-metastatic prostate cancer who are planning to receive curative-intent pelvic radiation therapy, with or without androgen deprivation therapy (ADT). Men who have had chemotherapy, immunotherapy, prior ADT, or have metastatic prostate cancer needing more than 24 months of ADT cannot participate.

Inclusion Criteria

I am a man aged 18 or older.

I am scheduled for radiation therapy aimed at curing my pelvic cancer, with or without hormone therapy.

My prostate cancer has not spread to other parts of my body.

My prostate cancer has returned but hasn't spread to other parts.

Exclusion Criteria

I have previously received chemotherapy or immunotherapy.

My prostate cancer needs hormone therapy for more than 24 months.

I have been treated with hormone therapy for cancer.

Treatment Details

The study compares the effects of two hormone therapies on heart health in men receiving radiation for prostate cancer. Leuprolide, a standard treatment with known cardiac risks is being compared against Relugolix, a newer FDA-approved drug that may be less harmful to the heart.

3Treatment groups

Experimental Treatment

Active Control

Group I: Arm III (radiation therapy plus relugolix)Experimental Treatment2 Interventions

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.

Group II: Arm II (radiation therapy plus leuprolide)Experimental Treatment2 Interventions

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.

Group III: Arm I (radiation therapy alone)Active Control1 Intervention

Patients undergo definitive radiation therapy alone (IMRT, SBRT, proton therapy, brachytherapy) in the absence of disease progression or unacceptable toxicity.

Leuprolide is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Lupron for: