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Hormone Therapy

Relugolix + Abiraterone Acetate vs Leuprolide + Abiraterone Acetate for Prostate Cancer

Phase 3

Waitlist Available

Led By Sagar A Patel, MD

Research Sponsored by Emory University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Men ≥ 18 years old

Planning to undergo curative-intent pelvic radiation therapy (photons or protons) with or without brachytherapy

Must not have

Metastatic prostate cancer requiring indefinitive ADT or chemotherapy

Prior exposure to androgen deprivation therapy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at months 6 and 12

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

"This trial compares the effects of two different hormone therapies, leuprolide and abiraterone acetate, versus relugolix and abiraterone acetate on the heart in prostate

Who is the study for?

This trial is for hormone-naive men with advanced prostate cancer who will receive pelvic radiation therapy. Participants should not have a history of heart disease or high blood pressure due to the potential impact of hormone therapy on cardiac health.

What is being tested?

The study compares two hormonal treatments: leuprolide plus abiraterone acetate versus relugolix plus abiraterone acetate, assessing their effects on the heart using advanced CT imaging and blood tests.

What are the potential side effects?

Potential side effects include hot flashes, fatigue, joint pain, erectile dysfunction from lowered testosterone levels; also possible are heart-related issues such as changes in blood pressure and increased risk of cardiovascular events.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am a man aged 18 or older.

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I am scheduled for radiation therapy aimed at curing my pelvic cancer.

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

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

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I am planning to start hormone therapy with AA and prednisone for up to 24 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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My prostate cancer has spread and needs ongoing hormone therapy or chemotherapy.

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I have been treated with hormone therapy for cancer.

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I have previously undergone chemotherapy, immunotherapy, or radiation therapy.

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I have had heart bypass surgery or a procedure to open my heart's arteries.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at months 6 and 12

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at months 6 and 12

This trial's timeline: 3 weeks for screening, Varies for treatment, and at months 6 and 12 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of ambulatory systolic blood pressure (BP) > 140 or diastolic > 90 (measurement on 2 separate days)

Incidence of moderate-to-severe atherosclerosis of major coronary vessels

Need for new or escalated anti-hypertensive medication

Secondary study objectives

Castration rate

Pre-existing genomic alterations promoting inflammatory immunity and associated with cardiovascular disease

Sustained castration

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Arm II (relugolix + abiraterone acetate/prednisone)Experimental Treatment6 Interventions

Patients receive oral relugolix daily plus oral abiraterone acetate (AA) with prednisone daily for up to 24 months in the absence of disease progression or unacceptable toxicity. Patients also undergo standard of care radiation therapy.

Group II: Arm I (leuprolide plus abiraterone acetate/prednisone)Experimental Treatment7 Interventions

Patients receive leuprolide IM or SC injections every 3 to 6 months plus oral abiraterone acetate (AA) with prednisone daily for up to 24 months in the absence of disease progression or unacceptable toxicity. Patients also undergo standard of care radiation therapy.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Leuprolide

2008

Completed Phase 4

~19000

Relugolix

2016

Completed Phase 3

~5410