Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-25 @ 7:10 PM
Study NCT ID:
NCT06831032
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-03-04
First Post:
2025-02-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Elective Adaptive Radiation With SBRT for Improved DurabilitY of Response
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 26}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2029-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-27', 'studyFirstSubmitDate': '2025-02-13', 'studyFirstSubmitQcDate': '2025-02-13', 'lastUpdatePostDateStruct': {'date': '2025-03-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2029-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quantify adverse events using CTCAE v5.0', 'timeFrame': '2 years', 'description': 'Acute toxicities (≤3 months) and long-term toxicities (related to urinary, bowel or sexual function) will be collected and evaluated by the CTCAE v5.0.'}], 'secondaryOutcomes': [{'measure': 'QoL using EPIC questionnaire', 'timeFrame': '2 years', 'description': 'Quality of life (QOL) will be collected using expanded prostate cancer index composite (EPIC) questionnaire. The quality-of-life scores will be converted to a scale of 0-100 for each category. A higher score indicates a better quality of life.'}, {'measure': 'Pain levels using EPIC questionnaire', 'timeFrame': '2 years', 'description': 'Pain levels will be collected using expanded prostate cancer index composite (EPIC) questionnaire. The quality-of-life scores will be converted to a scale of 0-100 for each category. A higher score indicates a better quality of life.'}, {'measure': 'Urinary function using EPIC questionnaire', 'timeFrame': '2 years', 'description': 'Urinary function will be collected using expanded prostate cancer index composite (EPIC) questionnaire. The quality-of-life scores will be converted to a scale of 0-100 for each category. A higher score indicates a better quality of life.'}, {'measure': 'Bowel function using EPIC questionnaire', 'timeFrame': '2 years', 'description': 'Bowel function will be collected using expanded prostate cancer index composite (EPIC) questionnaire. The quality-of-life scores will be converted to a scale of 0-100 for each category. A higher score indicates a better quality of life.'}, {'measure': 'Assessment of adaptive RT approach using dose accumulation', 'timeFrame': '2 years', 'description': 'Dosimetric assessment of the CBCT-guided online adaptive RT approach using dose accumulation.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Adenocarcinoma', 'Iliac Nodal Disease', 'Para-aortic Lymph Node Metastasis', 'Para-aortic Nodal Disease', 'Oligorecurrence']}, 'descriptionModule': {'briefSummary': 'This prospective, single-arm feasibility study will include patients with prostate cancer that have controlled local disease diagnosed with oligorecurrent para-aortic nodal disease and/or common iliac nodal disease detected by PSMA PET or conventional CT/MRI imaging, and these patients will undergo CT-guided online adaptive SBRT to the tumor and elective SBRT to adjacent at-risk nodal regions.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Histologically confirmed prostate adenocarcinoma.\n2. Oligorecurrent para-aortic +/- common iliac nodal disease planned for SBRT.\n3. ≤10 involved para-aortic (defined as between L1/L2 interface and L4/L5 interface) +/- common iliac LN on PSMA PET imaging.\n4. ECOG performance status 0-2.\n\nExclusion Criteria:\n\n1. Prior radiotherapy to the nodal echelon (PA +/- common iliac).\n2. Active secondary malignancy, except for adequately treated non-melanoma skin cancer.\n3. Presence of significant comorbidities or medical conditions that may compromise the ability to undergo radiotherapy or participate in the study.\n4. Contraindication to radiation.'}, 'identificationModule': {'nctId': 'NCT06831032', 'acronym': 'EASY', 'briefTitle': 'Elective Adaptive Radiation With SBRT for Improved DurabilitY of Response', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'A Phase I, Prospective, Single-Arm Feasibility Study: Elective Adaptive Radiation With SBRT for Improved DurabilitY of Response (EASY)', 'orgStudyIdInfo': {'id': '24-6066'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SBRT delivered with CBCT-guided online adaptive RT', 'description': 'Patients will undergo CT guided online adaptive SBRT 30-40Gy to the tumor nodal GTV volume(s) plus 25Gy in 5 fractions ENI to PA nodes (+/- pelvic nodes).', 'interventionNames': ['Radiation: Adaptive radiotherapy using SBRT']}], 'interventions': [{'name': 'Adaptive radiotherapy using SBRT', 'type': 'RADIATION', 'description': 'Adaptive External beam radiotherapy using SBRT 30-40Gy to the tumor nodal GTV volume(s) plus 25 Gy in 5 fractions ENI to PA nodes (+ common iliac nodes)', 'armGroupLabels': ['SBRT delivered with CBCT-guided online adaptive RT']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'contacts': [{'name': 'Andrew McPartlin, MD', 'role': 'CONTACT', 'email': 'andrew.mcpartlin@uhn.ca', 'phone': '416-946-4501', 'phoneExt': '4855'}], 'facility': 'Princess Margaret Cancer Centre', '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'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}