Relugolix vs Leuprolide for Prostate Cancer

(REVELUTION Trial)

Recruiting at 3 trial locations

Overseen By Sagar A. Patel, MD

Age: 18+

Sex: Male

Trial Phase: Phase 4

Sponsor: Emory University

Disqualifiers: Metastatic prostate cancer, Chemotherapy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

93 Participants Needed

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.

Research Team

Sagar A. Patel, MD

Principal Investigator

Emory University Hospital/Winship Cancer Institute

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 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.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Radiation Therapy

Patients undergo definitive radiation therapy in the absence of disease progression or unacceptable toxicity

6 to 24 months

Hormone Therapy

Patients receive either leuprolide or relugolix as part of androgen deprivation therapy

6 to 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment, including cardiovascular events and testosterone levels

24 months

Treatment Details

Interventions

• Leuprolide
• Radiation therapy
• Relugolix

Trial Overview 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.

Participant Groups

Group I: Arm III (radiation therapy plus relugolix) Experimental Treatment 2 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 Treatment 2 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 Control 1 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:

• Advanced prostate cancer
• Endometriosis
• Uterine leiomyomata
• Central precocious puberty

Approved in European Union as Eligard for:

• Advanced prostate cancer
• Endometriosis
• Uterine leiomyomata
• Central precocious puberty

Approved in Canada as Viadur for:

• Advanced prostate cancer

Who Is Running the Clinical Trial?

Emory University

Lead Sponsor

Trials

1,735

Recruited

2,605,000+

Prostate Cancer Foundation

Collaborator

Trials

52

Recruited

3,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+