Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2025-12-27 @ 11:33 PM
Study NCT ID:
NCT00027794
Status:
COMPLETED
Last Update Posted:
2012-09-24
First Post:
2001-12-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radical Prostatectomy in Treating Patients With Locally Advanced 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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'lastUpdateSubmitDate': '2012-09-20', 'studyFirstSubmitDate': '2001-12-07', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2012-09-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['adenocarcinoma of the prostate', 'stage III prostate cancer'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '16624554', 'type': 'RESULT', 'citation': 'Van Poppel H, Vekemans K, Da Pozzo L, Bono A, Kliment J, Montironi R, Debois M, Collette L. Radical prostatectomy for locally advanced prostate cancer: results of a feasibility study (EORTC 30001). Eur J Cancer. 2006 May;42(8):1062-7. doi: 10.1016/j.ejca.2005.11.030. Epub 2006 Apr 18.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Radical prostatectomy may be an effective treatment for locally advanced prostate cancer.\n\nPURPOSE: Phase II trial to study the effectiveness of radical prostatectomy in treating patients who have locally advanced prostate cancer.', 'detailedDescription': "OBJECTIVES:\n\n* Determine the success rate of radical prostatectomy in patients with locally advanced adenocarcinoma of the prostate.\n* Determine the serious toxic event rate of this surgery in these patients.\n* Determine the pN status of patients treated with this surgery.\n* Determine the percentage of patients found to have organ-confined tumors (pT2) after undergoing this surgery.\n* Determine the 2-year prostate-specific antigen-free survival rate of patients treated with this surgery.\n* Determine the surgical morbidity rates of patients treated with this surgery.\n\nOUTLINE: This is a multicenter study.\n\nPatients undergo limited pelvic lymphadenectomy and then radical retropubic prostatectomy.\n\nPatients who are found to have pN-positive disease receive further treatment according to the investigator's discretion. Patients with pN0 disease are followed every 3 months for 1 year and then every 4 months for 1 year.\n\nPROJECTED ACCRUAL: A total of 32-74 patients will be accrued for this study."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed adenocarcinoma of the prostate\n\n * Unilateral cT3a, cN0, M0\n* Well or moderately differentiated tumor\n\n * Gleason score no greater than 7 (4 plus 3 or 3 plus 4)\n* Total serum prostate-specific antigen no greater than 20 ng/mL (Hybritech equivalent)\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 70 and under\n\nPerformance status:\n\n* WHO 0-1\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* WBC greater than 3,000/mm\\^3\n* Platelet count greater than 100,000/mm\\^3\n* Hemoglobin greater than 9 g/dL\n\nHepatic:\n\n* Bilirubin no greater than 1.5 times normal\n* ALT or AST less than 3 times normal\n* PT and PTT normal\n\nRenal:\n\n* Creatinine no greater than 1.5 mg/dL\n\nCardiovascular:\n\n* No preexisting uncontrolled cardiac disease, signs of cardiac failure, or rhythm disturbances requiring therapy\n* No myocardial infarction within the past 6 months\n\nPulmonary:\n\n* No gross abnormalities on chest x-ray\n\nOther:\n\n* No other disease that would preclude surgery\n* No other prior malignancy except adequately treated basal cell skin cancer\n* No other concurrent primary malignancy\n* No psychological, familial, sociological, or geographical condition that would preclude compliance\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* Not specified\n\nEndocrine therapy:\n\n* No prior hormonal therapy that would affect assessment of clinical T staging, margin positivity, or definitive pT staging\n\nRadiotherapy:\n\n* No prior pelvic radiotherapy that would affect surgical resectability and perioperative morbidity\n\nSurgery:\n\n* No prior surgery in the small pelvis (vascular surgery, mesh graft hernia repair, any surgery for benign prostatic hypertrophy, or transurethral resection of prostate) that would preclude prostatectomy'}, 'identificationModule': {'nctId': 'NCT00027794', 'briefTitle': 'Radical Prostatectomy in Treating Patients With Locally Advanced Prostate Cancer', 'organization': {'class': 'NETWORK', 'fullName': 'European Organisation for Research and Treatment of Cancer - EORTC'}, 'officialTitle': 'Radical Prostatectomy for Locally Advanced Prostate Cancer. A Feasibility Study', 'orgStudyIdInfo': {'id': 'EORTC-30001'}, 'secondaryIdInfos': [{'id': 'EORTC-30001'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'conventional surgery', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '3500', 'city': 'Hasselt', 'country': 'Belgium', 'facility': 'Virga Jesse Hospital', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}, {'zip': 'B-3000', 'city': 'Leuven', 'country': 'Belgium', 'facility': 'U.Z. Gasthuisberg', 'geoPoint': {'lat': 50.87959, 'lon': 4.70093}}, {'zip': '20132', 'city': 'Milan', 'country': 'Italy', 'facility': 'Istituto Scientifico H. San Raffaele', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '21100', 'city': 'Varese', 'country': 'Italy', 'facility': 'Ospedale di Circolo e Fondazione Macchi', 'geoPoint': {'lat': 45.82058, 'lon': 8.82511}}, {'zip': '03659', 'city': 'Martin', 'country': 'Slovakia', 'facility': 'Martin Faculty Hospital', 'geoPoint': {'lat': 49.06651, 'lon': 18.92399}}], 'overallOfficials': [{'name': 'Hein van Poppel, MD, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital, Gasthuisberg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'European Organisation for Research and Treatment of Cancer - EORTC', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}