Ignite Creation Date:
2025-12-26 @ 4:00 PM
Ignite Modification Date:
2026-01-21 @ 7:52 PM
Study NCT ID:
NCT05320406
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-06
First Post:
2022-03-18
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
RElugolix VErsus LeUprolide Cardiac Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2025-09-02', 'type': 'ESTIMATED'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D050397', 'term': 'Radiotherapy, Intensity-Modulated'}, {'id': 'D061766', 'term': 'Proton Therapy'}, {'id': 'D001918', 'term': 'Brachytherapy'}, {'id': 'D016634', 'term': 'Radiosurgery'}, {'id': 'D016729', 'term': 'Leuprolide'}, {'id': 'C561634', 'term': 'relugolix'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D020266', 'term': 'Radiotherapy, Conformal'}, {'id': 'D011881', 'term': 'Radiotherapy, Computer-Assisted'}, {'id': 'D063193', 'term': 'Heavy Ion Radiotherapy'}, {'id': 'D013238', 'term': 'Stereotaxic Techniques'}, {'id': 'D019635', 'term': 'Neurosurgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}, {'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'sagar.patel@emory.edu', 'phone': '404-778-1900', 'title': 'Dr. Sagar Patel', 'organization': 'Emory University'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '12 months', 'eventGroups': [{'id': 'EG000', 'title': 'Arm I (Radiation Therapy Alone)', 'description': 'Patients undergo definitive radiation therapy alone (IMRT, SBRT, proton therapy, brachytherapy) in the absence of disease progression or unacceptable toxicity.\n\nRadiation therapy: Undergo radiation therapy', 'otherNumAtRisk': 28, 'deathsNumAtRisk': 28, 'otherNumAffected': 23, 'seriousNumAtRisk': 28, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Arm II (Radiation Therapy Plus Leuprolide)', 'description': 'Patients undergo radiation therapy as in Arm I and receive leuprolide SC or IM every 3 or 6 months. Treatment continues for 6 to 12 months (depending on risk) in the absence of disease progression or unacceptable toxicity.\n\nRadiation therapy: Undergo radiation therapy\n\nLeuprolide: Given IM or SC', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 27, 'seriousNumAtRisk': 31, 'deathsNumAffected': 1, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Arm III (Radiation Therapy Plus Relugolix)', 'description': 'Patients undergo radiation therapy as in Arm I and receive relugolix PO QD. Treatment continues for 6 to 12 months (depending on risk) in the absence of disease progression or unacceptable toxicity.\n\nRadiation therapy: Undergo radiation therapy\n\nRelugolix: Given PO', 'otherNumAtRisk': 31, 'deathsNumAtRisk': 31, 'otherNumAffected': 30, 'seriousNumAtRisk': 31, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Cystitis noninfective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 6, 'numAffected': 6}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 16, 'numAffected': 13}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 14, 'numAffected': 12}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Diarrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 14, 'numAffected': 10}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 24, 'numAffected': 14}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 13, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 33, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 29, 'numAffected': 26}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Hot flashes', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 27, 'numAffected': 18}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 24, 'numAffected': 20}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary frequency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 14, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 24, 'numAffected': 22}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 29, 'numAffected': 24}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary retention', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 11, 'numAffected': 9}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 19, 'numAffected': 14}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Urinary urgency', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 11, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 19, 'numAffected': 15}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 20, 'numAffected': 19}], 'organSystem': 'Renal and urinary disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'seriousEvents': [{'term': 'sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 28, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 31, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 31, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Total Coronary Plaque Volume in Major Coronary Arteries (i.e. Left Anterior Descending, Left Circumflex, Right Major Coronary Arteries)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Radiation Therapy Alone)', 'description': 'Patients undergo definitive radiation therapy alone (IMRT, SBRT, proton therapy, brachytherapy) in the absence of disease progression or unacceptable toxicity.\n\nRadiation therapy: Undergo radiation therapy'}, {'id': 'OG001', 'title': 'Arm II (Radiation Therapy Plus Leuprolide)', 'description': 'Patients undergo radiation therapy as in Arm I and receive leuprolide SC or IM every 3 or 6 months. Treatment continues for 6 to 12 months (depending on risk) in the absence of disease progression or unacceptable toxicity.\n\nRadiation therapy: Undergo radiation therapy\n\nLeuprolide: Given IM or SC'}, {'id': 'OG002', 'title': 'Arm III (Radiation Therapy Plus Relugolix)', 'description': 'Patients undergo radiation therapy as in Arm I and receive relugolix PO QD. Treatment continues for 6 to 12 months (depending on risk) in the absence of disease progression or unacceptable toxicity.\n\nRadiation therapy: Undergo radiation therapy\n\nRelugolix: Given PO'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '103.0', 'groupId': 'OG000', 'lowerLimit': '79.0', 'upperLimit': '182.0'}, {'value': '204.0', 'groupId': 'OG001', 'lowerLimit': '73.0', 'upperLimit': '556.5'}, {'value': '272.0', 'groupId': 'OG002', 'lowerLimit': '65.0', 'upperLimit': '766.0'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '130.0', 'groupId': 'OG000', 'lowerLimit': '55.0', 'upperLimit': '265.0'}, {'value': '290.0', 'groupId': 'OG001', 'lowerLimit': '153.0', 'upperLimit': '655.5'}, {'value': '265.0', 'groupId': 'OG002', 'lowerLimit': '100.0', 'upperLimit': '807.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From baseline to 12 months post-treatment initiation', 'description': 'Using cardiac computed tomography angiography (CCTA), total coronary plaque volume will be determined using an artificial intelligence-enabled quantitative coronary plaque analysis (AI-QCPA) through a commercially available and validated software service (HeartFlow, Inc). Each coronary artery (right coronary, left main, left anterior descending, and left circumflex) will be scored, and plaque volumes were summed over all segments.', 'unitOfMeasure': 'mm3', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Non-calcified Coronary Plaque Volume in Major Coronary Arteries (i.e. Left Anterior Descending, Left Circumflex, Right Major Coronary Arteries)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Radiation Therapy Alone)', 'description': 'Patients undergo definitive radiation therapy alone (IMRT, SBRT, proton therapy, brachytherapy) in the absence of disease progression or unacceptable toxicity.\n\nRadiation therapy: Undergo radiation therapy'}, {'id': 'OG001', 'title': 'Arm II (Radiation Therapy Plus Leuprolide)', 'description': 'Patients undergo radiation therapy as in Arm I and receive leuprolide SC or IM every 3 or 6 months. Treatment continues for 6 to 12 months (depending on risk) in the absence of disease progression or unacceptable toxicity.\n\nRadiation therapy: Undergo radiation therapy\n\nLeuprolide: Given IM or SC'}, {'id': 'OG002', 'title': 'Arm III (Radiation Therapy Plus Relugolix)', 'description': 'Patients undergo radiation therapy as in Arm I and receive relugolix PO QD. Treatment continues for 6 to 12 months (depending on risk) in the absence of disease progression or unacceptable toxicity.\n\nRadiation therapy: Undergo radiation therapy\n\nRelugolix: Given PO'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '98.0', 'groupId': 'OG000', 'lowerLimit': '74.0', 'upperLimit': '167.0'}, {'value': '157.0', 'groupId': 'OG001', 'lowerLimit': '65.5', 'upperLimit': '464.5'}, {'value': '206.0', 'groupId': 'OG002', 'lowerLimit': '56.0', 'upperLimit': '620.0'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '112.0', 'groupId': 'OG000', 'lowerLimit': '42.0', 'upperLimit': '215.0'}, {'value': '252.0', 'groupId': 'OG001', 'lowerLimit': '133.0', 'upperLimit': '511.0'}, {'value': '236.0', 'groupId': 'OG002', 'lowerLimit': '92.0', 'upperLimit': '613.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From baseline to 12 months post-treatment initiation', 'description': 'Using cardiac computed tomography angiography (CCTA), total coronary plaque volume will be determined using an artificial intelligence-enabled quantitative coronary plaque analysis (AI-QCPA) through a commercially available and validated software service (HeartFlow, Inc). Each coronary artery (right coronary, left main, left anterior descending, and left circumflex) will be scored, and plaque volumes were summed over all segments.', 'unitOfMeasure': 'mm3', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Calcified and Low-attenuation Coronary Plaque Volume in Major Coronary Arteries (i.e. Left Anterior Descending, Left Circumflex, Right Major Coronary Arteries)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Radiation Therapy Alone)', 'description': 'Patients undergo definitive radiation therapy alone (IMRT, SBRT, proton therapy, brachytherapy) in the absence of disease progression or unacceptable toxicity.\n\nRadiation therapy: Undergo radiation therapy'}, {'id': 'OG001', 'title': 'Arm II (Radiation Therapy Plus Leuprolide)', 'description': 'Patients undergo radiation therapy as in Arm I and receive leuprolide SC or IM every 3 or 6 months. Treatment continues for 6 to 12 months (depending on risk) in the absence of disease progression or unacceptable toxicity.\n\nRadiation therapy: Undergo radiation therapy\n\nLeuprolide: Given IM or SC'}, {'id': 'OG002', 'title': 'Arm III (Radiation Therapy Plus Relugolix)', 'description': 'Patients undergo radiation therapy as in Arm I and receive relugolix PO QD. Treatment continues for 6 to 12 months (depending on risk) in the absence of disease progression or unacceptable toxicity.\n\nRadiation therapy: Undergo radiation therapy\n\nRelugolix: Given PO'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '11.5', 'groupId': 'OG000', 'lowerLimit': '2.3', 'upperLimit': '25.8'}, {'value': '34.0', 'groupId': 'OG001', 'lowerLimit': '5.8', 'upperLimit': '98.8'}, {'value': '41.0', 'groupId': 'OG002', 'lowerLimit': '9.0', 'upperLimit': '175.0'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '13.0', 'groupId': 'OG000', 'lowerLimit': '4.0', 'upperLimit': '38.8'}, {'value': '44.0', 'groupId': 'OG001', 'lowerLimit': '12.3', 'upperLimit': '109.0'}, {'value': '46.0', 'groupId': 'OG002', 'lowerLimit': '16.0', 'upperLimit': '185.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From baseline to 12 months post-treatment initiation', 'description': 'Using cardiac computed tomography angiography (CCTA), total coronary plaque volume will be determined using an artificial intelligence-enabled quantitative coronary plaque analysis (AI-QCPA) through a commercially available and validated software service (HeartFlow, Inc). Each coronary artery (right coronary, left main, left anterior descending, and left circumflex) will be scored, and plaque volumes were summed over all segments.', 'unitOfMeasure': 'mm3', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Coronary Artery Calcium Score (CACS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Radiation Therapy Alone)', 'description': 'Patients undergo definitive radiation therapy alone (IMRT, SBRT, proton therapy, brachytherapy) in the absence of disease progression or unacceptable toxicity.\n\nRadiation therapy: Undergo radiation therapy'}, {'id': 'OG001', 'title': 'Arm II (Radiation Therapy Plus Leuprolide)', 'description': 'Patients undergo radiation therapy as in Arm I and receive leuprolide SC or IM every 3 or 6 months. Treatment continues for 6 to 12 months (depending on risk) in the absence of disease progression or unacceptable toxicity.\n\nRadiation therapy: Undergo radiation therapy\n\nLeuprolide: Given IM or SC'}, {'id': 'OG002', 'title': 'Arm III (Radiation Therapy Plus Relugolix)', 'description': 'Patients undergo radiation therapy as in Arm I and receive relugolix PO QD. Treatment continues for 6 to 12 months (depending on risk) in the absence of disease progression or unacceptable toxicity.\n\nRadiation therapy: Undergo radiation therapy\n\nRelugolix: Given PO'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '24.9', 'groupId': 'OG000', 'lowerLimit': '5.3', 'upperLimit': '91.3'}, {'value': '106.6', 'groupId': 'OG001', 'lowerLimit': '4.5', 'upperLimit': '249.6'}, {'value': '96.0', 'groupId': 'OG002', 'lowerLimit': '14.0', 'upperLimit': '390.1'}]}]}, {'title': 'Month 12', 'categories': [{'measurements': [{'value': '36.0', 'groupId': 'OG000', 'lowerLimit': '6.8', 'upperLimit': '101.8'}, {'value': '102.7', 'groupId': 'OG001', 'lowerLimit': '19.9', 'upperLimit': '262.5'}, {'value': '109.8', 'groupId': 'OG002', 'lowerLimit': '31.8', 'upperLimit': '509.3'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'From baseline to 12 months post-treatment initiation', 'description': 'The CACS will be measured by the Agatston score (range 0-400, with higher scores indicating more coronary artery calcium) on precontrast cardiac computed tomography anigiography (CCTA) scans by two blinded, board-certified cardiologists.', 'unitOfMeasure': 'Agatston score (range 0-400)', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Number of Participants With <30%, 30-49%, 50-69%, and >70% Maximum Coronary Vessel Stenosis at Baseline and Month 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Radiation Therapy Alone)', 'description': 'Patients undergo definitive radiation therapy alone (IMRT, SBRT, proton therapy, brachytherapy) in the absence of disease progression or unacceptable toxicity.\n\nRadiation therapy: Undergo radiation therapy'}, {'id': 'OG001', 'title': 'Arm II (Radiation Therapy Plus Leuprolide)', 'description': 'Patients undergo radiation therapy as in Arm I and receive leuprolide SC or IM every 3 or 6 months. Treatment continues for 6 to 12 months (depending on risk) in the absence of disease progression or unacceptable toxicity.\n\nRadiation therapy: Undergo radiation therapy\n\nLeuprolide: Given IM or SC'}, {'id': 'OG002', 'title': 'Arm III (Radiation Therapy Plus Relugolix)', 'description': 'Patients undergo radiation therapy as in Arm I and receive relugolix PO QD. Treatment continues for 6 to 12 months (depending on risk) in the absence of disease progression or unacceptable toxicity.\n\nRadiation therapy: Undergo radiation therapy\n\nRelugolix: Given PO'}], 'classes': [{'title': 'Baseline', 'categories': [{'title': '<30%', 'measurements': [{'value': '5', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}, {'title': '30% - 49%', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '8', 'groupId': 'OG002'}]}, {'title': '50% - 69%', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '16', 'groupId': 'OG002'}]}, {'title': '70% - 99%', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '3', 'groupId': 'OG002'}]}]}, {'title': 'Month 12', 'categories': [{'title': '<30%', 'measurements': [{'value': '6', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}, {'title': '30% - 49%', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}, {'title': '50% - 69%', 'measurements': [{'value': '10', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}]}, {'title': '70% - 99%', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline to 12 months post-treatment initiation', 'description': 'Coronary computed tomographic angiography post-contrast images were used for vessel stenosis, using an artificial intelligence-informed coronary stenosis quantification tool (AI-CSQ, Roadmap Analysis, Heart flow, Mountain View CA). Stenoses regions are defined in ranges of 0-29%, 30-49%, 50-69%, and \\>70%. The number of participants within each treatment meeting these stenosis thresholds were quantified at baseline and month 12.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Major Adverse Cardiovascular Events', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Radiation Therapy Alone)', 'description': 'Patients undergo definitive radiation therapy alone (IMRT, SBRT, proton therapy, brachytherapy) in the absence of disease progression or unacceptable toxicity.\n\nRadiation therapy: Undergo radiation therapy'}, {'id': 'OG001', 'title': 'Arm II (Radiation Therapy Plus Leuprolide)', 'description': 'Patients undergo radiation therapy as in Arm I and receive leuprolide SC or IM every 3 or 6 months. Treatment continues for 6 to 12 months (depending on risk) in the absence of disease progression or unacceptable toxicity.\n\nRadiation therapy: Undergo radiation therapy\n\nLeuprolide: Given IM or SC'}, {'id': 'OG002', 'title': 'Arm III (Radiation Therapy Plus Relugolix)', 'description': 'Patients undergo radiation therapy as in Arm I and receive relugolix PO QD. Treatment continues for 6 to 12 months (depending on risk) in the absence of disease progression or unacceptable toxicity.\n\nRadiation therapy: Undergo radiation therapy\n\nRelugolix: Given PO'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'From baseline to at least 2 years post-treatment initiation', 'description': 'Incidence of myocardial infarction, need for coronary revascularization, and/or sudden cardiac death will be measured for up to 2 years following enrollment.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Testosterone Kinetics', 'denoms': [{'units': 'Participants', 'counts': [{'value': '28', 'groupId': 'OG000'}, {'value': '31', 'groupId': 'OG001'}, {'value': '31', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Arm I (Radiation Therapy Alone)', 'description': 'Patients undergo definitive radiation therapy alone (IMRT, SBRT, proton therapy, brachytherapy) in the absence of disease progression or unacceptable toxicity.\n\nRadiation therapy: Undergo radiation therapy'}, {'id': 'OG001', 'title': 'Arm II (Radiation Therapy Plus Leuprolide)', 'description': 'Patients undergo radiation therapy as in Arm I and receive leuprolide SC or IM every 3 or 6 months. Treatment continues for 6 to 12 months (depending on risk) in the absence of disease progression or unacceptable toxicity.\n\nRadiation therapy: Undergo radiation therapy\n\nLeuprolide: Given IM or SC'}, {'id': 'OG002', 'title': 'Arm III (Radiation Therapy Plus Relugolix)', 'description': 'Patients undergo radiation therapy as in Arm I and receive relugolix PO QD. Treatment continues for 6 to 12 months (depending on risk) in the absence of disease progression or unacceptable toxicity.\n\nRadiation therapy: Undergo radiation therapy\n\nRelugolix: Given PO'}], 'classes': [{'title': '0', 'categories': [{'measurements': [{'value': '254.433', 'spread': '16.365', 'groupId': 'OG000'}, {'value': '292.735', 'spread': '15.114', 'groupId': 'OG001'}, {'value': '254.548', 'spread': '15.828', 'groupId': 'OG002'}]}]}, {'title': '3', 'categories': [{'measurements': [{'value': '266.358', 'spread': '16.633', 'groupId': 'OG000'}, {'value': '37.483', 'spread': '10.254', 'groupId': 'OG001'}, {'value': '26.468', 'spread': '7.325', 'groupId': 'OG002'}]}]}, {'title': '6', 'categories': [{'measurements': [{'value': '260.606', 'spread': '17.815', 'groupId': 'OG000'}, {'value': '31.063', 'spread': '8.018', 'groupId': 'OG001'}, {'value': '25.538', 'spread': '5.325', 'groupId': 'OG002'}]}]}, {'title': '12', 'categories': [{'measurements': [{'value': '253.631', 'spread': '18.149', 'groupId': 'OG000'}, {'value': '142.007', 'spread': '18.503', 'groupId': 'OG001'}, {'value': '199.673', 'spread': '16.573', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline and month 0, 3, 6, 12', 'description': 'Change in total testosterone levels (ng/dL) will be measured at baseline and month 0, 3, 6, and 12 between treatment arms. Testosterone change over time will be summarized and plotted over time for each treatment arm.', 'unitOfMeasure': 'ng/mL', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm I (Radiation Therapy Alone)', 'description': 'Patients undergo definitive radiation therapy alone (IMRT, SBRT, proton therapy, brachytherapy) in the absence of disease progression or unacceptable toxicity.\n\nRadiation therapy: Undergo radiation therapy'}, {'id': 'FG001', 'title': 'Arm II (Radiation Therapy Plus Leuprolide)', 'description': 'Patients undergo radiation therapy as in Arm I and receive leuprolide SC or IM every 3 or 6 months. Treatment continues for 6 to 12 months (depending on risk) in the absence of disease progression or unacceptable toxicity.\n\nRadiation therapy: Undergo radiation therapy\n\nLeuprolide: Given IM or SC'}, {'id': 'FG002', 'title': 'Arm III (Radiation Therapy Plus Relugolix)', 'description': 'Patients undergo radiation therapy as in Arm I and receive relugolix PO QD. Treatment continues for 6 to 12 months (depending on risk) in the absence of disease progression or unacceptable toxicity.\n\nRadiation therapy: Undergo radiation therapy\n\nRelugolix: Given PO'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '29'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '31'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '28'}, {'groupId': 'FG001', 'numSubjects': '28'}, {'groupId': 'FG002', 'numSubjects': '29'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '6'}, {'groupId': 'FG002', 'numSubjects': '2'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '29', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '94', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Arm I (Radiation Therapy Alone)', 'description': 'Patients undergo definitive radiation therapy alone (IMRT, SBRT, proton therapy, brachytherapy) in the absence of disease progression or unacceptable toxicity.\n\nRadiation therapy: Undergo radiation therapy'}, {'id': 'BG001', 'title': 'Arm II (Radiation Therapy Plus Leuprolide)', 'description': 'Patients undergo radiation therapy as in Arm I and receive leuprolide SC or IM every 3 or 6 months. Treatment continues for 6 to 12 months (depending on risk) in the absence of disease progression or unacceptable toxicity.\n\nRadiation therapy: Undergo radiation therapy\n\nLeuprolide: Given IM or SC'}, {'id': 'BG002', 'title': 'Arm III (Radiation Therapy Plus Relugolix)', 'description': 'Patients undergo radiation therapy as in Arm I and receive relugolix PO QD. Treatment continues for 6 to 12 months (depending on risk) in the absence of disease progression or unacceptable toxicity.\n\nRadiation therapy: Undergo radiation therapy\n\nRelugolix: Given PO'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '27', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '67', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '65.79', 'spread': '6.75', 'groupId': 'BG000'}, {'value': '68.85', 'spread': '8.12', 'groupId': 'BG001'}, {'value': '68.81', 'spread': '8.83', 'groupId': 'BG002'}, {'value': '67.89', 'spread': '8.02', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '94', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '11', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '24', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '22', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}, {'value': '62', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '34', 'groupId': 'BG001'}, {'value': '31', 'groupId': 'BG002'}, {'value': '94', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-09-05', 'size': 619182, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_002.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-09-23T21:20', 'hasProtocol': True}, {'date': '2025-03-19', 'size': 723264, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-05-09T11:09', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 94}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-06-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2025-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-23', 'studyFirstSubmitDate': '2022-03-18', 'resultsFirstSubmitDate': '2025-08-13', 'studyFirstSubmitQcDate': '2022-04-01', 'lastUpdatePostDateStruct': {'date': '2025-10-06', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2025-09-18', 'studyFirstPostDateStruct': {'date': '2022-04-11', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-09-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Calcified and Low-attenuation Coronary Plaque Volume in Major Coronary Arteries (i.e. Left Anterior Descending, Left Circumflex, Right Major Coronary Arteries)', 'timeFrame': 'From baseline to 12 months post-treatment initiation', 'description': 'Using cardiac computed tomography angiography (CCTA), total coronary plaque volume will be determined using an artificial intelligence-enabled quantitative coronary plaque analysis (AI-QCPA) through a commercially available and validated software service (HeartFlow, Inc). Each coronary artery (right coronary, left main, left anterior descending, and left circumflex) will be scored, and plaque volumes were summed over all segments.'}, {'measure': 'Coronary Artery Calcium Score (CACS)', 'timeFrame': 'From baseline to 12 months post-treatment initiation', 'description': 'The CACS will be measured by the Agatston score (range 0-400, with higher scores indicating more coronary artery calcium) on precontrast cardiac computed tomography anigiography (CCTA) scans by two blinded, board-certified cardiologists.'}, {'measure': 'Number of Participants With <30%, 30-49%, 50-69%, and >70% Maximum Coronary Vessel Stenosis at Baseline and Month 12', 'timeFrame': 'From baseline to 12 months post-treatment initiation', 'description': 'Coronary computed tomographic angiography post-contrast images were used for vessel stenosis, using an artificial intelligence-informed coronary stenosis quantification tool (AI-CSQ, Roadmap Analysis, Heart flow, Mountain View CA). Stenoses regions are defined in ranges of 0-29%, 30-49%, 50-69%, and \\>70%. The number of participants within each treatment meeting these stenosis thresholds were quantified at baseline and month 12.'}, {'measure': 'Major Adverse Cardiovascular Events', 'timeFrame': 'From baseline to at least 2 years post-treatment initiation', 'description': 'Incidence of myocardial infarction, need for coronary revascularization, and/or sudden cardiac death will be measured for up to 2 years following enrollment.'}, {'measure': 'Testosterone Kinetics', 'timeFrame': 'Baseline and month 0, 3, 6, 12', 'description': 'Change in total testosterone levels (ng/dL) will be measured at baseline and month 0, 3, 6, and 12 between treatment arms. Testosterone change over time will be summarized and plotted over time for each treatment arm.'}], 'primaryOutcomes': [{'measure': 'Total Coronary Plaque Volume in Major Coronary Arteries (i.e. Left Anterior Descending, Left Circumflex, Right Major Coronary Arteries)', 'timeFrame': 'From baseline to 12 months post-treatment initiation', 'description': 'Using cardiac computed tomography angiography (CCTA), total coronary plaque volume will be determined using an artificial intelligence-enabled quantitative coronary plaque analysis (AI-QCPA) through a commercially available and validated software service (HeartFlow, Inc). Each coronary artery (right coronary, left main, left anterior descending, and left circumflex) will be scored, and plaque volumes were summed over all segments.'}], 'secondaryOutcomes': [{'measure': 'Non-calcified Coronary Plaque Volume in Major Coronary Arteries (i.e. Left Anterior Descending, Left Circumflex, Right Major Coronary Arteries)', 'timeFrame': 'From baseline to 12 months post-treatment initiation', 'description': 'Using cardiac computed tomography angiography (CCTA), total coronary plaque volume will be determined using an artificial intelligence-enabled quantitative coronary plaque analysis (AI-QCPA) through a commercially available and validated software service (HeartFlow, Inc). Each coronary artery (right coronary, left main, left anterior descending, and left circumflex) will be scored, and plaque volumes were summed over all segments.'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Biochemically Recurrent Prostate Carcinoma', 'Localized Prostate Carcinoma', 'Stage I Prostate Cancer AJCC v8', 'Stage II Prostate Cancer AJCC v8', 'Stage IIA Prostate Cancer AJCC v8', 'Stage IIB Prostate Cancer AJCC v8', 'Stage IIC Prostate Cancer AJCC v8', 'Stage III Prostate Cancer AJCC v8', 'Stage IIIA Prostate Cancer AJCC v8', 'Stage IIIB Prostate Cancer AJCC v8', 'Stage IIIC Prostate Cancer AJCC v8']}, 'descriptionModule': {'briefSummary': 'This 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.', 'detailedDescription': 'PRIMARY OBJECTIVES:\n\nI. Identify and compare the association of gonadotrophin releasing hormone (GNRH)-agonist leuprolide versus GNRH-antagonist relugolix with coronary atherosclerosis and progression in men with prostate cancer.\n\nII. Determine the relationship between leuprolide versus relugolix with downstream immune effector response that is implicated in atherosclerosis.\n\nII. Determine how pre-existing genomic alterations associated with proinflammatory immunity impact development of CV toxicity following GNRH-agonist (GNRHa) versus relugolix.\n\nIII. Identify imaging biomarkers associated with increased risk of CV toxicity from ADT\n\nOUTLINE: Patients undergoing radiation therapy alone as part of their standard treatment are assigned to Arm I. Patients undergoing radiation therapy and ADT as part of their standard treatment are randomized to Arm II or Arm III.\n\nARM I: Patients undergo definitive radiation therapy in the absence of disease progression or unacceptable toxicity.\n\nARM II: Patients undergo radiation therapy as in Arm I and receive leuprolide subcutaneously (SC) or intramuscularly (IM) every 3 or 6 months. Treatment continues for 6 to 24 months (depending on cancer risk) in the absence of disease progression or unacceptable toxicity.\n\nARM III: Patients undergo radiation therapy as in Arm I and receive relugolix orally (PO) once daily (QD) for 6 to 24 months (depending on risk) in the absence of disease progression or unacceptable toxicity.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men \\>= 18 years old\n* Non-metastatic prostate cancer\n* Non-metastatic, biochemically recurrent prostate cancer\n* Plan to undergo curative-intent pelvic radiation therapy with or without ADT\n\nExclusion Criteria:\n\n* Metastatic prostate cancer requiring \\> 24 months of ADT\n* Prior exposure to androgen deprivation therapy\n* Prior exposure to chemotherapy or immunotherapy\n* History of cardiac bypass surgery or percutaneous coronary intervention'}, 'identificationModule': {'nctId': 'NCT05320406', 'acronym': 'REVELUTION', 'briefTitle': 'RElugolix VErsus LeUprolide Cardiac Trial', 'organization': {'class': 'OTHER', 'fullName': 'Emory University'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'STUDY00003654'}, 'secondaryIdInfos': [{'id': 'NCI-2022-00117', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'STUDY00003654'}, {'id': 'RAD5484-21', 'type': 'OTHER', 'domain': 'Emory University Hospital/Winship Cancer Institute'}, {'id': 'P30CA138292', 'link': 'https://reporter.nih.gov/quickSearch/P30CA138292', 'type': 'NIH'}, {'id': '22YOUN21', 'type': 'OTHER_GRANT', 'domain': 'Prostate Cancer foundation'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Arm I (radiation therapy alone)', 'description': 'Patients undergo definitive radiation therapy alone (IMRT, SBRT, proton therapy, brachytherapy) in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Radiation: Radiation therapy']}, {'type': 'EXPERIMENTAL', 'label': 'Arm II (radiation therapy plus leuprolide)', 'description': 'Patients undergo radiation therapy as in Arm I and receive leuprolide SC or IM every 3 or 6 months. Treatment continues for 6 to 12 months (depending on risk) in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Radiation: Radiation therapy', 'Drug: Leuprolide']}, {'type': 'EXPERIMENTAL', 'label': 'Arm III (radiation therapy plus relugolix)', 'description': 'Patients undergo radiation therapy as in Arm I and receive relugolix PO QD. Treatment continues for 6 to 12 months (depending on risk) in the absence of disease progression or unacceptable toxicity.', 'interventionNames': ['Radiation: Radiation therapy', 'Drug: Relugolix']}], 'interventions': [{'name': 'Radiation therapy', 'type': 'RADIATION', 'otherNames': ['External beam radiation therapy', 'Intensity modulated radiation therapy', 'Proton therapy', 'Brachytherapy', 'Stereotactic body radiotherapy'], 'description': 'Undergo radiation therapy', 'armGroupLabels': ['Arm I (radiation therapy alone)', 'Arm II (radiation therapy plus leuprolide)', 'Arm III (radiation therapy plus relugolix)']}, {'name': 'Leuprolide', 'type': 'DRUG', 'otherNames': ['Leuprolide acetate', 'Lupron'], 'description': 'Given IM or SC', 'armGroupLabels': ['Arm II (radiation therapy plus leuprolide)']}, {'name': 'Relugolix', 'type': 'DRUG', 'otherNames': ['Orgovyx', 'TAK-385'], 'description': 'Given PO', 'armGroupLabels': ['Arm III (radiation therapy plus relugolix)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory Proton Therapy Center', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University Hospital Midtown', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Emory University/Winship Cancer Institute', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Emory Saint Joseph's Hospital", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Sagar A Patel, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University Hospital/Winship Cancer Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Emory University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'Prostate Cancer Foundation', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Sagar Patel', 'investigatorAffiliation': 'Emory University'}}}}