Comparing heart effects of two hormone therapies in advanced prostate cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase III trial evaluates the cardiovascular outcomes of leuprolide combined with abiraterone acetate versus relugolix combined with abiraterone acetate in hormone-naive men with advanced prostate cancer undergoing pelvic radiation therapy. The study aims to measure the impact of these hormone therapies on heart health and identify any genomic factors that may increase cardiovascular toxicity. Patients will be randomized into two groups, receiving either leuprolide or relugolix alongside standard treatment, with assessments including coronary computed tomography angiography and blood sample collection. The trial seeks to improve understanding of hormone therapy's effects on cardiovascular health in this patient population.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Men ≥ 18 years old
* Non-metastatic prostate cancer
* Non-metastatic, biochemically recurrent prostate cancer
* Plan to undergo curative-intent pelvic radiation therapy (photons or protons) with or without brachytherapy
* Plan to undergo up to 24 months of combination androgen deprivation therapy (ADT) plus AA and prednisone

Exclusion Criteria:

* Metastatic prostate cancer requiring indefinitive ADT or chemotherapy
* Prior exposure to androgen deprivation therapy
* Prior exposure to chemotherapy, immunotherapy, or radiation therapy
* History of cardiac bypass surgery or percutaneous coronary intervention
* History of cardiac pacemaker or defibrillator

Where it's running

• Emory Proton Therapy Center
  Atlanta, Georgia, United States Recruiting
• Winship at Emory Midtown
  Atlanta, Georgia, United States Recruiting
• Emory University Hospital/Winship Cancer Institute
  Atlanta, Georgia, United States Recruiting
• Emory Saint Joseph's Hospital
  Atlanta, Georgia, United States Recruiting

Study contacts

• Principal investigator: Sagar A Patel, MD — Emory University Hospital/Winship Cancer Institute
• Study coordinator: Bill Zheng, BS
• Email: bill.zheng@emory.edu
• Phone: 404-686-6856

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Combining high dose-rate brachytherapy and stereotactic body radiotherapy for prostate cancer treatment

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• MRI or CT planning to guide high-dose-rate prostate brachytherapy

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  Recruiting at 3 sites Emory University · Atlanta, Georgia and 2 other locations · NCT07859722

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.