protocolSection identificationModule nctId: NCT06330805, orgStudyIdInfo id: OSU-23069, secondaryIdInfos id: NCI-2024-00705, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), briefTitle: Effects of Relugolix vs Leuprolide on Cardiac Function in Patients With Prostate Cancer, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2027-12-31, studyFirstPostDateStruct date: 2024-03-26, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Ohio State University Comprehensive Cancer Center, class: OTHER, collaborators name: Pfizer, collaborators name: Myovant Sciences GmbH, collaborators name: Sumitomo Pharmaceuticals America, descriptionModule briefSummary: This phase II trial compares the effect of relugolix to leuprolide on cardiac function and performance in patients with prostate cancer. Androgen deprivation therapy (ADT) has been a key component for the treatment of advanced prostate cancer for decades. The term androgen deprivation therapy means lowering a man's testosterone. Long-term studies show that ADT may contribute to a detriment to cardiac health and predisposes men to developing cardiac diseases. Recent studies suggest that men taking relugolix for treatment of prostate cancer may have a lower risk of developing cardiovascular problems, but more studies are needed to understand this observation, and there are currently no studies reporting the direct impact of ADT (relugolix, versus the more-commonly used leuprolide) on cardiac function and outcomes.Participants will receive definitive radiotherapy for unfavorable intermediate risk prostate cancer and 6-month ADT (either relugolix or leuprolide). In addition, participants will undergo the following:1. Comprehensive cardiac and exercise testing before and after starting ADT2. Completion of quality-of-life questionnaires at specific intervals during the study period3. Provide blood samples at specific intervals during the study period to test for changes in steroid levels and certain biomarkers, conditionsModule conditions: Prostate Adenocarcinoma, conditions: Stage IIB Prostate Cancer AJCC v8, conditions: Stage IIC Prostate Cancer AJCC v8, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Biospecimen Collection, interventions name: Contrast Agent, interventions name: Leuprolide, interventions name: Magnetic Resonance Imaging, interventions name: Physical Performance Testing, interventions name: Relugolix, outcomesModule primaryOutcomes measure: Physiologic alterations in cardiopulmonary function - Myocardial perfusion, primaryOutcomes measure: Physiologic alterations in cardiopulmonary function - Maximal rate of oxygen consumption, secondaryOutcomes measure: Quality of life using EPIC-26, secondaryOutcomes measure: Quality of life using EORTC QLQ-C30, secondaryOutcomes measure: Quality of life using European (Euro) Qol-5-Dimension 5-level (EQ-5D-5L), secondaryOutcomes measure: Quality of life using PROMIS, secondaryOutcomes measure: Functional tests of strength and balance using Timed Up-and-Go, secondaryOutcomes measure: Functional tests of strength and balance using 10-meter walk time, secondaryOutcomes measure: Functional tests of strength and balance using Grip strength, secondaryOutcomes measure: Changes in body composition, eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ohio State University Comprehensive Cancer Center, city: Columbus, state: Ohio, zip: 43210, country: United States, contacts name: Shang-Jui Wang, role: CONTACT, phone: 614-366-9306, email: Shang-Jui.Wang@osumc.edu, contacts name: Shang-Jui Wang, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.96118, lon: -82.99879, hasResults: False