Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2026-01-04 @ 8:41 PM
Study NCT ID:
NCT06508567
Status:
RECRUITING
Last Update Posted:
2025-02-10
First Post:
2024-03-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Salvage MR-guided High-Dose-Rate Brachytherapy for Prostate Bed Recurrence After Radiotherapy in the PSMA PET Scan Era
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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2031-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-06', 'studyFirstSubmitDate': '2024-03-15', 'studyFirstSubmitQcDate': '2024-07-12', 'lastUpdatePostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-08-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dosimetry Parameters', 'timeFrame': '5 Years', 'description': 'As this is a safety and feasibility study, the PTV coverage could be compromised to meet the OAR constraints'}, {'measure': 'Acute toxicity assessed by CTCAE V5.0 (Grade ≥3)', 'timeFrame': '5 Years', 'description': 'Determine the number of patients with late genitourinary, gastrointestinal and/or sexual toxicities as a result of salvage HDR Brachytherapy treatment at a grade ≥3'}], 'secondaryOutcomes': [{'measure': 'Biochemical Control assessed by PSA', 'timeFrame': '5 Years', 'description': 'Determine the number of patients demonstrating biochemical control of PSA following salvage HDR Brachytherapy treatment.'}, {'measure': 'Local Disease Control', 'timeFrame': '2 Years', 'description': 'Assessed by MRI/PSMA-PET imaging at 2 years'}, {'measure': 'Changes in Quality of Life', 'timeFrame': '5 years', 'description': 'Assessed with EPIC Quality of Life scores yearly for 5 years.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Cancer Recurrent', 'Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'This is an interventional, single-centre, single-arm, non-randomized, prospective, feasibility trial investigating salvage MR-guided High-Dose-Rate brachytherapy for prostate bed recurrence after postoperative radiotherapy.', 'detailedDescription': 'Patients who received previous adjuvant or salvage radiotherapy to the prostate bed \\>\n\nIsolated prostate bed recurrence based on PSMA PET, biopsy-proven, and MR visible \\>\n\nBaseline: QoLs questionnaires, PSA, pelvic magnetic resonance imaging (MRI) scan for RT planning \\>\n\nTwo fractions of 13 Gy each delivered over 7-21 days. GTV(HDR) delineation (based on MRI-guided and PSMA PET, biopsy data as applicable) \\>\n\nFollow-Up after treatment 60 months: PSA, CTCAE v5.0, MRI pelvis +/- PSMA-PET scan (optional at 24 months)'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients who received previous RT to the prostate bed +/- pelvic nodal regions\n2. Prostate-bed recurrence identified by biopsy and/or MRI and/or PSMA-PET scan\n3. At least two continuous PSA elevations post RT and PSA above 0.2 ng/dl\n4. With or without ADT PSA doubling time from nadir greater than 6 months\n5. ECOG 0-2\n6. Age greater than 18 years\n\nExclusion Criteria:\n\n1. Radiological (e.g. PSMA PET, CT, MRI or bone scan) evidence of or distant metastases\n2. History of ≥G3 gastrointestinal (GI) and genitourinary (GU) toxicities following RT\n3. Any contraindications to MR and/or brachytherapy'}, 'identificationModule': {'nctId': 'NCT06508567', 'acronym': 'SHAPE-PSMA', 'briefTitle': 'Salvage MR-guided High-Dose-Rate Brachytherapy for Prostate Bed Recurrence After Radiotherapy in the PSMA PET Scan Era', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'Salvage MR-guided High-Dose-Rate Brachytherapy for Prostate Bed Recurrence After Radiotherapy in the PSMA PET Scan Era', 'orgStudyIdInfo': {'id': '23-6023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '2xHDR Brachytherapy', 'description': 'Salvage MR-guided High-Dose-Rate Brachytherapy for Prostate Bed recurrence after Postoperative Radiotherapy.', 'interventionNames': ['Radiation: High Dose Rate Brachytherapy']}], 'interventions': [{'name': 'High Dose Rate Brachytherapy', 'type': 'RADIATION', 'description': '2 fractions of MRI-guided HDR Brachytherapy (13Gy each) delivered over 14 days (± 7 days).', 'armGroupLabels': ['2xHDR Brachytherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G1Z5', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Peter Chung', 'role': 'CONTACT', 'email': 'peter.chung@uhn.ca', 'phone': '416-946-4501', 'phoneExt': '3374'}], 'facility': 'Princess Margaret Cancer Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Peter Chung, MD', 'role': 'CONTACT', 'email': 'peter.chung@uhn.ca', 'phone': '416-946-4501', 'phoneExt': '3374'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}