Ignite Creation Date:
2025-12-25 @ 3:08 AM
Ignite Modification Date:
2026-03-03 @ 12:03 AM
Study NCT ID:
NCT05328505
Status:
RECRUITING
Last Update Posted:
2024-09-26
First Post:
2022-04-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Molecular Imaging Informed Radiation Dose Escalation to Sites of Recurrent Disease and De-escalation to Uninvolved Areas in Salvage Radiotherapy for Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D012008', 'term': 'Recurrence'}], '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'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D061089', 'term': 'Radiotherapy, Image-Guided'}], 'ancestors': [{'id': 'D011878', 'term': 'Radiotherapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-08-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2030-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-09-24', 'studyFirstSubmitDate': '2022-04-07', 'studyFirstSubmitQcDate': '2022-04-07', 'lastUpdatePostDateStruct': {'date': '2024-09-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Grade ≥2 Toxicity for GU', 'timeFrame': 'Baseline to 5-year follow-up', 'description': 'Acute (less than or equal to 90 days) toxicity will be evaluated by using prospective follow-up and grading according to the latest version of the Common Terminology Criteria for Adverse Events (CTCAE) v5.0.'}], 'secondaryOutcomes': [{'measure': 'Biochemical Failure Free Survival', 'timeFrame': 'Baseline to 5-year follow-up', 'description': 'Biochemical control rate will be assessed at baseline and at each follow-up visit (1, 3, 6, 12, 18, 24, 36, 48, and 60 months) by the blood level of prostate-specific antigen (PSA) levels'}, {'measure': 'Patient-reported quality-of-life assessed by EPIC-26', 'timeFrame': 'Baseline to 5-year follow-up', 'description': 'Patient-Reported Quality of Life will be assessed at baseline and at each follow-up visit (3-weeks post intervention then every 6 months until 5 years, or more frequently if clinically necessary) using the following assessment questionnaires: 26-Item Expanded Prostate Cancer Index Composite (EPIC-26)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Prostate Cancer', 'adenocarcinoma', 'PSMA PET', 'radical prostatectomy', 'recurrence'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'This is a Phase II prospective sing-arm trial that is recruiting 60 participants from patients that have biochemical failure after radical prostatectomy with local or regional recurrence proven by PSMA PET. Participants of this study will receive molecular imaging informed radiation dose escalation to site of recurrent disease and de-escalation to uninvolved areas. Participants will be follow-up as per standard of care up to 5 years post-treatment.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men older than 18 years old.\n* Histologically proven initial diagnosis of adenocarcinoma prostate cancer.\n* Previous radical prostatectomy.\n* Biochemical relapse with local or regional recurrence proven on PSMA PET.\n* Five or less positive nodes on the PSMA PET.\n* ECOG 0-1\n\nExclusion Criteria:\n\n* Presence of para-aortic lymph nodes or distant metastasis.\n* Chronic pelvic inflammatory disease.\n* Contraindication for radiation treatment.\n* Previous radiation treatment within the pelvis'}, 'identificationModule': {'nctId': 'NCT05328505', 'acronym': 'MIDAS-Prostate', 'briefTitle': 'Molecular Imaging Informed Radiation Dose Escalation to Sites of Recurrent Disease and De-escalation to Uninvolved Areas in Salvage Radiotherapy for Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'Molecular Imaging Informed Radiation Dose Escalation to Sites of Recurrent Disease and De-escalation to Uninvolved Areas in Salvage Radiotherapy for Prostate Cancer', 'orgStudyIdInfo': {'id': '22-5147'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Molecular Imaging Informed Radiation Dose Escalation and De-escalation', 'description': 'Molecular imaging informed radiation dose escalation to sites of recurrent disease and de-escalation to uninvolved areas.', 'interventionNames': ['Radiation: Image-guided Radiotherapy']}], 'interventions': [{'name': 'Image-guided Radiotherapy', 'type': 'RADIATION', 'description': 'de-escalation radiotherapy to elective volumes + simultaneous integrated boost to PSMA avid lesions delivered in 20 fractions +/- ADT (clinical decision). The elective prostate bed and pelvic lymph node regions will receive 45 Gy. The PSMA-avid lymph node(s) will receive an SIB to 55-60 Gy and/or the PSMA-avid lesion in the prostate bed will receive an SIB to 60 Gy. Pelvic nodal treatment and ADT use will be left to the discretion of the treating physician.', 'armGroupLabels': ['Molecular Imaging Informed Radiation Dose Escalation and De-escalation']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Andrew McPartlin, MD', 'role': 'CONTACT', 'email': 'andrew.mcpartlin@uhn.ca'}], 'facility': 'Princess Margaret Cancer Center', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Andrew McPartlin, MD', 'role': 'CONTACT', 'email': 'andrew.mcpartlin@uhn.ca', 'phone': '416-946-4501', 'phoneExt': '4855'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}