Ignite Creation Date:
2025-12-25 @ 12:09 AM
Ignite Modification Date:
2026-01-02 @ 10:11 AM
Study NCT ID:
NCT07132658
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-20
First Post:
2025-06-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
MRI-guided Ultrahypofractionated SBRT Prostate Program
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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2030-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-12', 'studyFirstSubmitDate': '2025-06-19', 'studyFirstSubmitQcDate': '2025-08-12', 'lastUpdatePostDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-08-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Biochemical Relapse-Free Survival', 'timeFrame': '5-years', 'description': 'To achieve a 4-year biochemical relapse-free survival of 95%.'}, {'measure': 'Adverse Events', 'timeFrame': '5-years', 'description': 'To decrease urinary grade 3 or greater toxicity below 3% and rectal grade 3 or greater toxicity below 1%.'}], 'secondaryOutcomes': [{'measure': 'Quality of Life (QOL) assessment', 'timeFrame': '5-years', 'description': 'Determination of QOL with International Prostate Symptom Score (IPSS) and European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-PR25. IPSS ranges from 0 to 35 with higher values representing worse functioning. EORTC QLQ PR-25 ranges from 0-100 with higher values representing better functioning.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prostate Cancer', 'NCCN Low Risk', 'NCCN Favorable Intermediate Risk'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if the use of MRI-guided asymmetric ultrahipofractionated irradiation (2 fractions with dose increase in the tumor areas and dose sparing in urethra, rectum and neurovascular bundles) produces similar results in terms of local control and complications to standard 5-fraction SBRT.', 'detailedDescription': 'The implementation of Magnetic Resonance Image Guided Radiotherapy (MRgRT) into a Prostate Cancer Program aims to reproduce the results obtained with state-of-the-art brachytherapy or EBRT with the added advantage of convenience and lack of invasiveness.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Optimal Inclusion Criteria\n\n* Patients with low to favorable intermediate-risk prostate cancer as per the NCCN stratification criteria .\n* No prior radiation therapy to the target areas\n* Expected patient survival \\>5 years\n* Patient able to undergo a MRI exam\n\nCautionary Inclusion Criteria\n\n* Suboptimal candidates for high-dose therapy such as elderly, frail patients or patients with large volume glands (i.e, \\>60cm3) or extensive TURP in the prior 6-12 months should be considered cautionary indications.\n* Patients with higher risk but low volume disease not candidates for ENI may be treated on an individual basis\n\nExclusion Criteria\n\n* Prior radiation therapy to the target areas\n* Expected patient survival below 5 years\n* Patient unable to undergo a MRI exam'}, 'identificationModule': {'nctId': 'NCT07132658', 'briefTitle': 'MRI-guided Ultrahypofractionated SBRT Prostate Program', 'organization': {'class': 'OTHER', 'fullName': 'Clinica Universidad de Navarra, Universidad de Navarra'}, 'officialTitle': 'PROJECT#2: MRI-guided Local SBRT Prostate Program', 'orgStudyIdInfo': {'id': '2024.198'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Initial Phase', 'description': 'Whole Gland 36.25Gy/5Rx', 'interventionNames': ['Radiation: MR-Guided SBRT']}, {'type': 'EXPERIMENTAL', 'label': 'Study Phase', 'description': 'Whole Gland 27Gy/2Rx', 'interventionNames': ['Radiation: MR-Guided SBRT']}, {'type': 'EXPERIMENTAL', 'label': 'Final Phase', 'description': 'Asymmetrical Whole Gland 27Gy/2Rx', 'interventionNames': ['Radiation: MR-Guided SBRT']}], 'interventions': [{'name': 'MR-Guided SBRT', 'type': 'RADIATION', 'description': 'MR-Guided SBRT', 'armGroupLabels': ['Final Phase', 'Initial Phase', 'Study Phase']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Beatriz Ramos Aguirre, M.S.', 'role': 'CONTACT', 'email': 'ucicec@unav.es', 'phone': '+34948255400', 'phoneExt': '2772'}], 'overallOfficials': [{'name': 'Rafael Martínez-Monge, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clínica Universidad de Navarra'}, {'name': 'Luis Fuertes, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Clínica Universidad de Navarra'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF', 'CSR', 'ANALYTIC_CODE'], 'timeFrame': 'Jul 1st, 2025 to June 30, 2030', 'ipdSharing': 'YES', 'description': 'On request', 'accessCriteria': 'On request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinica Universidad de Navarra, Universidad de Navarra', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}