Trial results for the RElugolix VErsus LeUprolide Cardiac Trial (NCT05320406) investigating relugolix and leuprolide in men with prostate cancer were posted on ClinicalTrials.gov on 2025-09-22. The study's key measurements showed that both relugolix and leuprolide arms had higher median total and non-calcified coronary plaque volumes compared to radiation therapy alone, with median total coronary plaque volumes reaching up to 272.0 mm3 for relugolix and 290.0 mm3 for leuprolide.
Background
This trial investigates the impact of androgen deprivation therapy (ADT) on cardiovascular health in men with prostate cancer. Leuprolide is a commonly used hormone therapy for prostate cancer, and concerns about its cardiovascular toxicity have been noted. Relugolix is another hormone therapy drug that has recently been introduced.
Trial design
The RElugolix VErsus LeUprolide Cardiac Trial (NCT05320406) is a Phase 2 study with an enrollment of 94 participants. The trial includes men with Biochemically Recurrent Prostate Carcinoma, Localized Prostate Carcinoma, Stage I Prostate Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, and Stage IIA Prostate Cancer AJCC v8. The study compares three treatment arms: Arm I (Radiation Therapy Alone), Arm II (Radiation Therapy Plus Leuprolide), and Arm III (Radiation Therapy Plus Relugolix). The trial aims to investigate the impact of these treatments on the heart and coronary vessels.
Key results
The trial investigated changes in coronary plaque volume in major coronary arteries. Key measurements for "Total Coronary Plaque Volume" showed the following median values:
- For Arm I (Radiation Therapy Alone), median total coronary plaque volume was 103.0 mm3 and 130.0 mm3.
- For Arm II (Radiation Therapy Plus Leuprolide), median total coronary plaque volume was 204.0 mm3 and 290.0 mm3.
- For Arm III (Radiation Therapy Plus Relugolix), median total coronary plaque volume was 272.0 mm3 and 265.0 mm3.
For "Non-calcified Coronary Plaque Volume" in major coronary arteries, the median values were:
- For Arm I (Radiation Therapy Alone), median non-calcified coronary plaque volume was 98.0 mm3 and 112.0 mm3.
- For Arm II (Radiation Therapy Plus Leuprolide), median non-calcified coronary plaque volume was 157.0 mm3 and 252.0 mm3.
- For Arm III (Radiation Therapy Plus Relugolix), median non-calcified coronary plaque volume was 206.0 mm3 and 236.0 mm3.
What this means
The results suggest that both androgen deprivation therapies, leuprolide and relugolix, when administered with radiation therapy for prostate cancer, are associated with higher median total and non-calcified coronary plaque volumes compared to radiation therapy alone. While the comparison between leuprolide and relugolix showed mixed results across different measurements, the overall trend indicates a potential cardiovascular impact from these hormone therapies. These findings highlight the importance of monitoring cardiovascular health in patients undergoing ADT for prostate cancer.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05320406, titled "RElugolix VErsus LeUprolide Cardiac Trial," were posted on 2025-09-22 on clinicaltrials.gov.