Ignite Creation Date:
2025-12-25 @ 2:01 AM
Ignite Modification Date:
2026-01-28 @ 8:24 PM
Study NCT ID:
NCT00489060
Status:
COMPLETED
Last Update Posted:
2008-07-17
First Post:
2007-06-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized Trial of External Beam Radiotherapy Versus Cryoablation in Patients With Localized Prostate Cancer
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003452', 'term': 'Cryosurgery'}], 'ancestors': [{'id': 'D055011', 'term': 'Ablation Techniques'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 244}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1997-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-07', 'completionDateStruct': {'date': '2007-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-07-16', 'studyFirstSubmitDate': '2007-06-20', 'studyFirstSubmitQcDate': '2007-06-20', 'lastUpdatePostDateStruct': {'date': '2008-07-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-06-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'No evidence of disease progression (NEDP) at 36 months', 'timeFrame': '36 months'}], 'secondaryOutcomes': [{'measure': 'Prostate biopsy status', 'timeFrame': '36 months post treatment'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Cryoablation', 'Radiation', 'Prostate Cancer'], 'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'A trial to determine if cryoablation is as effective as radiation in the treatment of men with localized prostate cancer.', 'detailedDescription': 'Men with newly diagnosed localized prostate cancer were randomly assigned to cryoablation or external beam radiotherapy (median dose 68 Gy). All patients received neoadjuvant antiandrogen therapy. The primary endpoint was disease progression at 36 months based on a trifecta definition of failure: (a) radiological evidence of metastatic disease or b) initiation of further antineoplastic therapy or c) biochemical failure). Two definitions of biochemical failure were used: 1) rising PSA with a final value \\>1.0 ng/mL and 2) rise above PSA nadir + 2 ng/mL. Secondary endpoints were overall survival, disease-specific survival, and positive prostate biopsy at 36 months.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Clinically localized prostate cancer\n* PSA \\< 20ng/ml\n* Negative bone scan\n\nExclusion Criteria:\n\n* Previous TURP\n* Previous hormone therapy'}, 'identificationModule': {'nctId': 'NCT00489060', 'briefTitle': 'A Randomized Trial of External Beam Radiotherapy Versus Cryoablation in Patients With Localized Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Calgary'}, 'officialTitle': 'A Randomized Trial of External Beam Radiotherapy Versus Cryoablation in Patients With Clinically Localized Prostate Cancer', 'orgStudyIdInfo': {'id': '9716'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Cryoablation and External Beam Radiation', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Calgary', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Tom Baker Cancer Center', 'geoPoint': {'lat': 51.05011, 'lon': -114.08529}}], 'overallOfficials': [{'name': 'Bryan Donnelly, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tom Baker Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Calgary', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Cancer Trials Group', 'class': 'NETWORK'}, {'name': 'AHS Cancer Control Alberta', 'class': 'OTHER'}]}}}