Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-26 @ 1:42 AM
Study NCT ID:
NCT05656794
Status:
RECRUITING
Last Update Posted:
2025-02-10
First Post:
2022-12-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Consolidative Prostate Radiotherapy in Metastatic Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2031-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-06', 'studyFirstSubmitDate': '2022-12-09', 'studyFirstSubmitQcDate': '2022-12-09', 'lastUpdatePostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-12-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2031-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rates of acute toxicity', 'timeFrame': '5 years', 'description': 'Compare rates of acute toxicity between participants in Arm 1 and Arm 2. Acute toxicity will be measured using CTCAE V5.0'}], 'secondaryOutcomes': [{'measure': 'Rates of late toxicity.', 'timeFrame': '5 years', 'description': 'Compare rates of late toxicity between participants in Arm 1 and Arm 2. Acute toxicity will be measured using CTCAE V5.0'}, {'measure': 'Measure failure-free survival', 'timeFrame': '5 years', 'description': 'Compare failure-free survival, collected through medical records, for participants in Arm 1 and Arm 2'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Prostate Metastases']}, 'descriptionModule': {'briefSummary': 'This is a prospective, randomized phase II trial investigating if radiation treatment delivered every other day for 2 weeks has the same side effects as radiation treatment delivered once weekly for 6 weeks.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Prostate cancer excludes women', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Histologically-proven metastatic prostate cancer\n* Presence of low-volume or high-volume metastases (high volume defined as the presence of visceral metastases or ≥4 bone lesions with at least 1 lesion beyond the vertebral bodies and pelvis.)\n* Planned to or receiving systemic treatment ADT +/- ARAT as per physician discretion (Previous chemotherapy allowed if completed more than 6 weeks prior to randomization.)\n* Planned for EBRT\n* ECOG 0 or 1\n* Age 18 years or older\n\nExclusion Criteria:\n\n* Prior radiotherapy to pelvis\n* Active ulcerative colitis or Crohn's Disease, at discretion of treating physician\n* Any condition where radiotherapy is contraindicated"}, 'identificationModule': {'nctId': 'NCT05656794', 'acronym': 'CONSORT-PC', 'briefTitle': 'Consolidative Prostate Radiotherapy in Metastatic Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'Consolidative Prostate Radiotherapy in Patients With Metastatic Prostate Cancer', 'orgStudyIdInfo': {'id': '22-5921'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1 - Investigational', 'description': 'Radiation treatment (36 Gy in 6 fractions) to be delivered every other day over 2 weeks (excluding weekends).', 'interventionNames': ['Radiation: Radiotherapy']}, {'type': 'OTHER', 'label': 'Arm 2 - Standard', 'description': 'Radiation treatment (36 Gy in 6 fractions) to be delivered once a week over 6 weeks.', 'interventionNames': ['Radiation: Radiotherapy']}], 'interventions': [{'name': 'Radiotherapy', 'type': 'RADIATION', 'description': 'Standard of care radiotherapy administered as per institutional guidelines.', 'armGroupLabels': ['Arm 1 - Investigational', 'Arm 2 - Standard']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 2M9', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Peter Chung, MD', 'role': 'CONTACT', 'email': 'peter.chung@uhn.ca', 'phone': '416-946-4501', 'phoneExt': '2126'}, {'name': 'Peter Chung, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'University Health Network, Princess Margaret Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Peter Chung, MD', 'role': 'CONTACT', 'email': 'peter.chung@rmp.uhn.ca', 'phone': '416-946-4501', 'phoneExt': '2126'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}