Ignite Creation Date:
2025-12-24 @ 11:41 PM
Ignite Modification Date:
2025-12-25 @ 9:32 PM
Study NCT ID:
NCT06129851
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-11-13
First Post:
2023-11-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Relugolix in Combination With Radiation Therapy for Treating Patients With High Risk Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D001918', 'term': 'Brachytherapy'}, {'id': 'D015502', 'term': 'Absorptiometry, Photon'}, {'id': 'D015519', 'term': 'Bone Density'}, {'id': 'D003226', 'term': 'Congresses as Topic'}, {'id': 'D011827', 'term': 'Radiation'}, {'id': 'D009682', 'term': 'Magnetic Resonance Spectroscopy'}, {'id': 'D043425', 'term': 'Glutamate Carboxypeptidase II'}, {'id': 'C561634', 'term': 'relugolix'}], 'ancestors': [{'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D011859', 'term': 'Radiography'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D003720', 'term': 'Densitometry'}, {'id': 'D010783', 'term': 'Photometry'}, {'id': 'D002623', 'term': 'Chemistry Techniques, Analytical'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D009938', 'term': 'Organizations'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}, {'id': 'D055585', 'term': 'Physical Phenomena'}, {'id': 'D013057', 'term': 'Spectrum Analysis'}, {'id': 'D002268', 'term': 'Carboxypeptidases'}, {'id': 'D020689', 'term': 'Exopeptidases'}, {'id': 'D010447', 'term': 'Peptide Hydrolases'}, {'id': 'D006867', 'term': 'Hydrolases'}, {'id': 'D004798', 'term': 'Enzymes'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D045727', 'term': 'Metalloexopeptidases'}, {'id': 'D045726', 'term': 'Metalloproteases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 90}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2023-11-20', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2026-10-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-03', 'studyFirstSubmitDate': '2023-11-03', 'studyFirstSubmitQcDate': '2023-11-03', 'lastUpdatePostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-10-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biochemical recurrence', 'timeFrame': 'Up to 3 years', 'description': 'Will be defined as serum prostate-specific antigen (PSA) level of nadir + 2 ng/mL by blood test.'}], 'secondaryOutcomes': [{'measure': 'Composite quality of Life', 'timeFrame': 'Up to 5 years', 'description': 'Will be assessed by the Expanded Prostate Composite Index Short Form (EPIC-26) and will be compared between the 2 arms in terms of hormonal domain and sexual domain of EPIC-26. An area under the curve (AUC) metric will be utilized to account for the overall quality of life from baseline through 36 months for each patient. A mixed effect model will be employed to construct an estimate of the difference in AUC between Arms A and B, including fixed effects of time, arm, and baseline characteristics (two or three covariates depending on the available sample size). A two-sample t-test with a significance level of 0.05 will be performed.'}, {'measure': 'Incidence of adverse events', 'timeFrame': 'Up to 5 years', 'description': 'Will be assessed by Common Terminology Criteria for Adverse Events version 5.0 and will be reported descriptively.'}, {'measure': 'Incidence of major adverse cardiovascular events', 'timeFrame': 'Up to 5 years', 'description': 'Will be assessed by medical record review and will be reported descriptively.'}, {'measure': 'Participant compliance', 'timeFrame': 'Up to 2 years', 'description': 'Will be assessed by patient study diary.'}, {'measure': 'Time to testosterone recovery', 'timeFrame': 'Up to 5 years', 'description': 'Will be assessed by blood tests and the percentage of patients in each arm who achieved baseline level or minimum 280 ng/dL will be reported at 3-month intervals up through 36 months after treatment completion.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Stage IIC Prostate Cancer AJCC v8', 'Stage III Prostate Cancer AJCC v8', 'Stage IV Prostate Cancer AJCC v8']}, 'descriptionModule': {'briefSummary': 'This phase II trial evaluates the best duration for relugolix to be given in combination with radiation therapy when treating patients with high risk prostate cancer. Prostate cancer is a hormonal influenced cancer. Part of the usual treatment for patients with prostate cancer is androgen deprivation therapy (ADT). ADT is used to lower the amount of testosterone in the body, because testosterone appears to help prostate cancer grow. Relugolix works to reduce testosterone levels, which may inhibit proliferation of prostate cancer cells. It is approved by the Food and Drug Administration to treat prostate cancer. Adding relugolix to standard radiation therapy might work better and have fewer side effects than prior forms of hormonal therapy, but the optimal duration of relugolix in combination with radiation is not known.', 'detailedDescription': 'PRIMARY OBJECTIVE:\n\nI. To compare the biochemical recurrence rate between 12 and 24 months of relugolix in patients with high risk prostate cancer treated with combination external beam radiation and brachytherapy.\n\nSECONDARY OBJECTIVES:\n\nI. To compare the composite quality of life in patient treated with 12 months and 24 months of relugolix as assessed by the Expanded Prostate Composite Index Short Form (EPIC-26) instrument.\n\nII. To compare the treatment related toxicity between 12 months and 24 months of relugolix as assessed by Common Terminology Criteria for Adverse Events version 5.0. (CTCAE v 5.0) criteria.\n\nIII. To compare the rate of major adverse cardiovascular events (MACE) in patients treated with 12 and 24 months of relugolix.\n\nIV. To establish the rate of patient compliance using patient reported drug diary.\n\nV. To compare the rate of testosterone recovery after 12 and 24 months of relugolix.\n\nEXPLORATORY OBJECTIVE:\n\nI. To establish Decipher genomic classifier as predictor of cancer control.\n\nOUTLINE: Patients are randomized to 1 of 2 arms.\n\nARM A: Patients receive relugolix orally (PO) once daily (QD). Cycles repeat every 3 months for 12 months in the absence of disease progression or unacceptable toxicity. Beginning 30 to 180 days after start of relugolix, patients undergo brachytherapy and external beam radiation over 25 fractions. Patients undergo bone scan, computed tomography (CT) or magnetic resonance imaging (MRI) or prostate-specific membrane antigen (PSMA) positron emission tomography (PET) scan during screening. Patients also undergo dual x-ray absorptiometry (DEXA) scan and may optionally undergo blood sample collection throughout the trial.\n\nARM B: Patients receive relugolix PO QD. Cycles repeat every 3 months for 24 months in the absence of disease progression or unacceptable toxicity. Beginning 30 to 180 days after start of relugolix, patients undergo brachytherapy and external beam radiation over 25 fractions. Patients undergo bone scan, CT or MRI or PSMA PET scan during screening. Patients also undergo DEXA scan and may optionally undergo blood sample collection throughout the trial.\n\nAfter completion of study treatment, patients in Arm A are followed up every 3 months for 12 months and then every 6 months for up to 36 months and patients in Arm B are followed up every 6 months for up 36 months.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ability of participant or Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent\n* Age ≥ 18 years\n* Eastern Cooperative Oncology Group (ECOG) performance status 0 - 1\n* Life expectancy \\> 5 years\n* Patient diagnosed with National Comprehensive Cancer Network (NCCN) high risk and very high risk prostate cancer.\n\n * High risk is defined as:\n\n * T3a or\n * Grade group 4 or 5 or\n * Prostate-specific antigen (PSA) \\> 20 ng/mL\n * Very high risk is defined as:\n\n * T3b to T4 or\n * Primary Gleason pattern 5 or\n * Two or three high-risk features or\n * \\> 4 cores with grade group 4 or 5\n* Eligible for treatment with combination brachytherapy, external beam radiation, and ADT\n* Leukocytes \\>= 1.0 K/UL\n* Platelets \\>= 100 K/UL\n* Hemoglobin ≥ 9 g/dL\n* Aspartate aminotransferase and alanine aminotransferase ≤ 2.5 x upper limit of normal (ULN)\n* Men with partners of child-bearing potential must agree to practice sexual abstinence or to use the forms of contraception listed for the duration of study participation and for 2 weeks following completion of relugolix therapy\n\nExclusion Criteria:\n\n* Simultaneously enrolled in any therapeutic clinical trial\n* Current or anticipating use of other anti-neoplastic or investigational agents while participating in this study\n* Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements\n* Has a known allergic reaction to any excipient or component contained in the study drug formulation\n* Active grade 3 (per the National Cancer Institute \\[NCI\\] CTCAE, version 5.0) or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study treatment\n* Current androgen deprivation therapy (unless testosterone \\> 50 ng/dL). Please note prior or concurrent bicalutamide at 50 mg/daily or less is allowed. Prior androgen deprivation therapy is allowed if testosterone has recovered to \\> 50 ng/dL\n* Prolonged echocardiogram corrected QT (QTc) interval \\> 440 ns\n* Prior pelvic therapy that would significantly overlap with radiation treatment fields\n* Prior prostatectomy'}, 'identificationModule': {'nctId': 'NCT06129851', 'briefTitle': 'Relugolix in Combination With Radiation Therapy for Treating Patients With High Risk Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Kansas Medical Center'}, 'officialTitle': 'Quantifying Optimal Relugolix Duration With Radiation in High Risk Prostate Cancer (QURE-PC)', 'orgStudyIdInfo': {'id': 'STUDY00150674'}, 'secondaryIdInfos': [{'id': 'NCI-2023-09079', 'type': 'REGISTRY', 'domain': 'CTRP (Clinical Trial Reporting Program)'}, {'id': 'STUDY00150674', 'type': 'OTHER', 'domain': 'University of Kansas Cancer Center'}, {'id': 'P30CA168524', 'link': 'https://reporter.nih.gov/quickSearch/P30CA168524', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A (relugolix, brachytherapy, external beam radiation)', 'description': 'Patients receive relugolix PO QD. Cycles repeat every 3 months for 12 months in the absence of disease progression or unacceptable toxicity. Beginning 30 to 180 days after start of relugolix, patients undergo brachytherapy and external beam radiation over 25 fractions. Patients undergo bone scan, CT or MRI or PSMA PET scan during screening. Patients also undergo DEXA scan and may optionally undergo blood sample collection throughout the trial.', 'interventionNames': ['Procedure: Biospecimen Collection', 'Procedure: Bone Scan', 'Radiation: Brachytherapy', 'Procedure: Computed Tomography', 'Procedure: Dual X-ray Absorptiometry', 'Radiation: External Beam Radiation Therapy', 'Procedure: Magnetic Resonance Imaging', 'Procedure: PSMA PET Scan', 'Other: Questionnaire Administration', 'Drug: Relugolix']}, {'type': 'EXPERIMENTAL', 'label': 'Arm B (relugolix, brachytherapy, external beam radiation)', 'description': 'Patients receive relugolix PO QD. Cycles repeat every 3 months for 24 months in the absence of disease progression or unacceptable toxicity. Beginning 30 to 180 days after start of relugolix, patients undergo brachytherapy and external beam radiation over 25 fractions. Patients undergo bone scan, CT or MRI or PSMA PET scan during screening. Patients also undergo DEXA scan and may optionally undergo blood sample collection throughout the trial.', 'interventionNames': ['Procedure: Biospecimen Collection', 'Procedure: Bone Scan', 'Radiation: Brachytherapy', 'Procedure: Computed Tomography', 'Procedure: Dual X-ray Absorptiometry', 'Radiation: External Beam Radiation Therapy', 'Procedure: Magnetic Resonance Imaging', 'Procedure: PSMA PET Scan', 'Other: Questionnaire Administration', 'Drug: Relugolix']}], 'interventions': [{'name': 'Biospecimen Collection', 'type': 'PROCEDURE', 'otherNames': ['Biological Sample Collection', 'Biospecimen Collected', 'Specimen Collection'], 'description': 'Undergo blood sample collection', 'armGroupLabels': ['Arm A (relugolix, brachytherapy, external beam radiation)', 'Arm B (relugolix, brachytherapy, external beam radiation)']}, {'name': 'Bone Scan', 'type': 'PROCEDURE', 'otherNames': ['Bone Scintigraphy'], 'description': 'Undergo bone scan', 'armGroupLabels': ['Arm A (relugolix, brachytherapy, external beam radiation)', 'Arm B (relugolix, brachytherapy, external beam radiation)']}, {'name': 'Brachytherapy', 'type': 'RADIATION', 'otherNames': ['Brachytherapy, NOS', 'Internal Radiation', 'Internal Radiation Brachytherapy', 'Internal Radiation Therapy', 'Radiation Brachytherapy', 'Radiation, Internal'], 'description': 'Undergo brachytherapy', 'armGroupLabels': ['Arm A (relugolix, brachytherapy, external beam radiation)', 'Arm B (relugolix, brachytherapy, external beam radiation)']}, {'name': 'Computed Tomography', 'type': 'PROCEDURE', 'otherNames': ['CAT', 'CAT Scan', 'Computed Axial Tomography', 'Computerized Axial Tomography', 'Computerized axial tomography (procedure)', 'Computerized Tomography', 'CT', 'CT Scan', 'tomography'], 'description': 'Undergo CT', 'armGroupLabels': ['Arm A (relugolix, brachytherapy, external beam radiation)', 'Arm B (relugolix, brachytherapy, external beam radiation)']}, {'name': 'Dual X-ray Absorptiometry', 'type': 'PROCEDURE', 'otherNames': ['BMD scan', 'bone mineral density scan', 'DEXA', 'DEXA (Bone Density)', 'DEXA Scan', 'dual energy x-ray absorptiometric scan', 'Dual Energy X-ray Absorptiometry', 'Dual X-Ray Absorptometry', 'DXA', 'DXA SCAN'], 'description': 'Undergo DEXA scan', 'armGroupLabels': ['Arm A (relugolix, brachytherapy, external beam radiation)', 'Arm B (relugolix, brachytherapy, external beam radiation)']}, {'name': 'External Beam Radiation Therapy', 'type': 'RADIATION', 'otherNames': ['Definitive Radiation Therapy', 'EBRT', 'External Beam Radiation', 'External Beam Radiotherapy', 'External Beam Radiotherapy (conventional)', 'External Beam RT', 'external radiation', 'External Radiation Therapy', 'external-beam radiation', 'Radiation, External Beam', 'Teleradiotherapy', 'Teletherapy', 'Teletherapy Radiation'], 'description': 'Undergo external beam radiation therapy', 'armGroupLabels': ['Arm A (relugolix, brachytherapy, external beam radiation)', 'Arm B (relugolix, brachytherapy, external beam radiation)']}, {'name': 'Magnetic Resonance Imaging', 'type': 'PROCEDURE', 'otherNames': ['Magnetic Resonance', 'Magnetic resonance imaging (procedure)', 'Magnetic Resonance Imaging Scan', 'Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance', 'MR', 'MR Imaging', 'MRI', 'MRI Scan', 'NMR Imaging', 'NMRI', 'Nuclear Magnetic Resonance Imaging'], 'description': 'Undergo MRI', 'armGroupLabels': ['Arm A (relugolix, brachytherapy, external beam radiation)', 'Arm B (relugolix, brachytherapy, external beam radiation)']}, {'name': 'PSMA PET Scan', 'type': 'PROCEDURE', 'otherNames': ['Prostate-specific Membrane Antigen PET', 'PSMA PET', 'PSMA-Positron emission tomography'], 'description': 'Undergo PSMA PET', 'armGroupLabels': ['Arm A (relugolix, brachytherapy, external beam radiation)', 'Arm B (relugolix, brachytherapy, external beam radiation)']}, {'name': 'Questionnaire Administration', 'type': 'OTHER', 'description': 'Ancillary studies', 'armGroupLabels': ['Arm A (relugolix, brachytherapy, external beam radiation)', 'Arm B (relugolix, brachytherapy, external beam radiation)']}, {'name': 'Relugolix', 'type': 'DRUG', 'otherNames': ["N-(4-(1-((2,6-Difluorophenyl)methyl)-5-((dimethylamino)methyl)-1,2,3,4-tetrahydro-3-(6-methoxy-3-pyridazinyl)-2,4-dioxothieno(2,3-d)pyrimidin-6-yl)phenyl)-N'-methoxyurea", 'Orgovyx', 'Relumina', 'TAK 385', 'TAK-385'], 'description': 'Given PO', 'armGroupLabels': ['Arm A (relugolix, brachytherapy, external beam radiation)', 'Arm B (relugolix, brachytherapy, external beam radiation)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '66160', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'contacts': [{'name': 'Xinglei Shen', 'role': 'CONTACT', 'email': 'xshen@kumc.edu', 'phone': '913-588-3600'}, {'name': 'Xinglei Shen', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University of Kansas Cancer Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}], 'overallOfficials': [{'name': 'Xinglei Shen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Kansas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Kansas Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Xinglei Shen', 'investigatorAffiliation': 'University of Kansas'}}}}