Ignite Creation Date:
2025-12-24 @ 6:26 PM
Ignite Modification Date:
2025-12-29 @ 11:10 AM
Study NCT ID:
NCT01488968
Status:
TERMINATED
Last Update Posted:
2025-06-29
First Post:
2011-12-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Conventional Versus Hypofractionated Radiation in High Risk Prostate Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 111}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2012-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2018-10-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-25', 'studyFirstSubmitDate': '2011-12-02', 'studyFirstSubmitQcDate': '2011-12-07', 'lastUpdatePostDateStruct': {'date': '2025-06-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The rate of late rectal toxicities between hypofractionated versus conventional fractionated schedules in high risk prostate cancer patients', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'measure': 'The biochemical control (freedom from PSA failure) rate', 'timeFrame': '10 years'}, {'measure': 'Disease free survival', 'timeFrame': '10 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['high risk prostate cancer', 'hypofractionated radiation treatment', 'higher biological doses', 'acceptable rectal toxicity', 'Radiation Treatment'], 'conditions': ['High-risk Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'Hypofractionated regimen in high-risk prostate cancer will allow the investigators to deliver higher biological doses to targets in order to improve tumor control and with acceptable rectal toxicity compared to conventional fractionation.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Patient is 18 years of age or older\n* Patient has histologically proven adenocarcinoma of prostate gland by needle core samples or TURP with assigned Gleason score. Prostate biopsy performed within 180 days of enrollment (date of consent).\n* Patient has high-risk prostate cancer (stage T3 or T4) and/or PSA greater than or equal to 20 ng/ml and/or Gleason score 8 to 10\n* No clinical or radiological evidence of nodal or distant metastasis(es).\n* In the opinion of the treating oncologist, patient is fit to undergo radical external beam radiotherapy to the prostate. Patients are accessible for treatment and follow up.\n* Patient does not have history of inflammatory bowel disease, anal stenosis, colorectal surgery, or repeated endoscopic examinations/interventions related to anorectal diseases.\n* No history of prostatectomy, transurethral resection of prostate on more than one occasion or previous pelvic radiotherapy.\n* No history of androgen suppression for greater than or equal to 6 months and patient is willing for androgen suppression treatment as per standard or at physician's discretion.\n* No previous malignancy within last five years except BCC or SCC skin or highly curable malignancy where a prognosis for cure is \\> 80%.\n* Patient signed informed consent."}, 'identificationModule': {'nctId': 'NCT01488968', 'acronym': 'CHIRP', 'briefTitle': 'Conventional Versus Hypofractionated Radiation in High Risk Prostate Patients', 'organization': {'class': 'OTHER', 'fullName': 'AHS Cancer Control Alberta'}, 'officialTitle': 'A Phase II Randomized Control Trial of Conventional Versus Hypofractionated Radiation Regimen in Single Phase Using IMRT Technique and Long Term Androgen Suppression Therapy in High-risk Prostate Cancer Patients.', 'orgStudyIdInfo': {'id': '25859'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard', 'description': 'Standard Radiation Treatment', 'interventionNames': ['Radiation: Standard Radiation Treatment']}, {'type': 'EXPERIMENTAL', 'label': 'Hypofractionated', 'description': 'Hypofractionated', 'interventionNames': ['Radiation: Hypofractionated radiation treatment']}], 'interventions': [{'name': 'Standard Radiation Treatment', 'type': 'RADIATION', 'description': '39 radiation treatments', 'armGroupLabels': ['Standard']}, {'name': 'Hypofractionated radiation treatment', 'type': 'RADIATION', 'description': '25 radiation treatments', 'armGroupLabels': ['Hypofractionated']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'T6G 1Z2', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Cross Cancer Institute', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}], 'overallOfficials': [{'name': 'Albert Murtha', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Cross Cancer Institute'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AHS Cancer Control Alberta', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}