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Clinical trial

Mechanism and Predictors of Cardiotoxicity After Prostate Cancer Treatment: A Parallel Cohort and Randomized Trial Comparing Radiation Alone, Radiation Plus Leuprolide, and Radiation Plus Relugolix

ID
Name
STUDY00003654
Description
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.
Trial arms
Trial start
2022-06-06
Estimated PCD
2025-01-30
Trial end
2026-01-30
Status
Active (not recruiting)
Phase
Early phase I
Treatment
Radiation therapy
Undergo radiation therapy
Arms:
Arm I (radiation therapy alone), Arm II (radiation therapy plus leuprolide), Arm III (radiation therapy plus relugolix)
Other names:
External beam radiation therapy, Intensity modulated radiation therapy, Proton therapy, Brachytherapy, Stereotactic body radiotherapy
Leuprolide
Given IM or SC
Arms:
Arm II (radiation therapy plus leuprolide)
Other names:
Leuprolide acetate, Lupron
Relugolix
Given PO
Arms:
Arm III (radiation therapy plus relugolix)
Other names:
Orgovyx, TAK-385
Size
93
Primary endpoint
Coronary plaque volume in major coronary arteries (i.e. left anterior descending, left circumflex, right major coronary arteries)
From baseline to 12 months post-treatment initiation
Incidence of high-risk coronary plaque features at month 12 after treatment initiation
From baseline to 12 months post-treatment initiation
Major adverse cardiovascular events
From baseline to at least 2 years post-treatment initiation
Eligibility criteria
Inclusion Criteria: * Men \>= 18 years old * Non-metastatic prostate cancer * Non-metastatic, biochemically recurrent prostate cancer * Plan to undergo curative-intent pelvic radiation therapy with or without ADT Exclusion Criteria: * Metastatic prostate cancer requiring \> 24 months of ADT * Prior exposure to androgen deprivation therapy * Prior exposure to chemotherapy or immunotherapy
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 93, 'type': 'ACTUAL'}}
Updated at
2024-06-03

1 organization

2 drugs

4 indications

Organization
Emory University
Drug
LHRH agonist
Indication
Recurrent Prostate Carcinoma
Indication
Prostate Cancer
Indication
Prostate Cancer, Stage III AJCC v8
Indication
Prostate Cancer Stage IIIB AJCC v8
Drug
Relugolix