Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2025-12-25 @ 1:48 PM
Study NCT ID:
NCT00006359
Status:
COMPLETED
Last Update Posted:
2016-07-18
First Post:
2000-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Androgen Suppression Plus Radiation Therapy in Treating Patients With 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': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}, {'id': 'D000726', 'term': 'Androgen Antagonists'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D010906', 'term': 'Pituitary Hormone-Releasing Hormones'}, {'id': 'D007028', 'term': 'Hypothalamic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D009479', 'term': 'Neuropeptides'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D009842', 'term': 'Oligopeptides'}, {'id': 'D009419', 'term': 'Nerve Tissue Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D006727', 'term': 'Hormone Antagonists'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-07', 'completionDateStruct': {'date': '2012-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-07-15', 'studyFirstSubmitDate': '2000-10-04', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2016-07-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Toxicity', 'timeFrame': 'q 3 mon for 2 yrs post tx initiation'}], 'secondaryOutcomes': [{'measure': 'Time to PSA failure', 'timeFrame': '6 years'}, {'measure': 'Survival', 'timeFrame': '6 years', 'description': 'Progression free and overall survival will be assessed'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['adenocarcinoma of the prostate', 'stage I prostate cancer', 'stage II prostate cancer', 'stage III prostate cancer'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'type': 'RESULT', 'citation': 'Hurwitz MD, Halabi S, Archer L, et al.: Combination external beam radiation and brachytherapy boost with androgen suppression for treatment of intermediate-risk prostate cancer: long-term results of CALGB 99809. [Abstract] 2010 Genitourinary Cancers Symposium, March 5-7, 2010, San Francisco, California. A-192, 2010.'}, {'pmid': '18407435', 'type': 'RESULT', 'citation': 'Hurwitz MD, Halabi S, Ou SS, McGinnis LS, Keuttel MR, Dibiase SJ, Small EJ. Combination external beam radiation and brachytherapy boost with androgen suppression for treatment of intermediate-risk prostate cancer: an initial report of CALGB 99809. Int J Radiat Oncol Biol Phys. 2008 Nov 1;72(3):814-9. doi: 10.1016/j.ijrobp.2008.01.010. Epub 2008 Apr 11.'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as leuprolide, goserelin, flutamide, or bicalutamide, may stop the adrenal glands from making androgens. Radiation therapy uses high-energy x-rays to damage tumor cells. Giving these drugs together with radiation therapy may kill more tumor cells.\n\nPURPOSE: This phase II trial is studying how well androgen suppression with either leuprolide or goserelin and either flutamide or bicalutamide together with radiation therapy works in treating patients with prostate cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the feasibility of androgen-suppression therapy combined with external-beam radiotherapy and boost brachytherapy (EBRT+BT) in patients with intermediate-risk localized prostate cancer.\n* Determine the safety of EBRT+BT in these patients.\n* Determine, in a preliminary manner, the efficacy of EBRT+BT in terms of rate of local recurrence at 5 years, time to prostate-specific antigen failure, and time to first rectal/bladder injury, in these patients.\n\nOUTLINE: Patients receive either leuprolide intramuscularly or goserelin subcutaneously once every 12 weeks for a total of 24 weeks. Patients also receive either oral flutamide three times daily or oral bicalutamide once daily for 4 weeks.\n\nWithin 4 weeks after initiation of androgen-suppression therapy, patients undergo external-beam radiotherapy (EBRT) once daily, 5 days a week, for 5 weeks. At 2-4 weeks after completion of EBRT, patients undergo transrectal ultrasound-guided boost brachytherapy with implanted iodine I 125 or palladium Pd 103 seeds.\n\nPatients are followed every 3 months for 2 years and then every 6 months for 4 years.\n\nPROJECTED ACCRUAL: A total of 60 patients will be accrued for this study.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed adenocarcinoma of the prostate\n\n * Must have one of the following prognostic factors:\n\n * Stage T1-2, N0; prostate-specific antigen (PSA) ≤ 10 ng/mL; and Gleason score \\> 6\n * Stage T1-2, N0; PSA \\> 10 ng/mL and \\< 20 ng/mL; and Gleason score ≤ 6\n * Stage T3a, N0; PSA ≤ 10 ng/mL; and Gleason score ≤ 6\n* Prostate volume \\< 60 cc by transrectal ultrasound\n* No distant or nodal metastases\n\n * No metastatic disease by bone scan, CT scan, or MRI\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 18 and over\n\nPerformance status:\n\n* ECOG 0-2\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Absolute neutrophil count ≥ 1,500/mm\\^3\n* Platelet count ≥ 100,000/mm\\^3\n\nHepatic:\n\n* Bilirubin ≤ 1.5 times upper limit of normal\n\nRenal:\n\n* Not specified\n\nOther:\n\n* Fertile patients must use effective contraception\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* No prior immunotherapy for prostate cancer\n\nChemotherapy:\n\n* No prior chemotherapy for prostate cancer\n\nEndocrine therapy:\n\n* Prior androgen-suppression therapy for up to 4 weeks duration allowed if initiated within 4 weeks of study radiotherapy\n* No other prior hormonal therapy\n\nRadiotherapy:\n\n* No prior radiotherapy for prostate cancer\n\nSurgery:\n\n* No prior surgery for prostate cancer\n* No prior transurethral resection of the prostate\n\nOther:\n\n* No prior alternative therapy (e.g., PC-SPES) for prostate cancer'}, 'identificationModule': {'nctId': 'NCT00006359', 'briefTitle': 'Androgen Suppression Plus Radiation Therapy in Treating Patients With Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'Alliance for Clinical Trials in Oncology'}, 'officialTitle': 'Phase II Trial of Androgen Suppression for 6 Months Combined With External Beam Radiotherapy (EBRT) With Brachytherapy (BT) Boost for Intermediate Risk Prostate Cancer', 'orgStudyIdInfo': {'id': 'CALGB-99809'}, 'secondaryIdInfos': [{'id': 'U10CA031946', 'link': 'https://reporter.nih.gov/quickSearch/U10CA031946', 'type': 'NIH'}, {'id': 'CALGB-99809'}, {'id': 'CDR0000068228', 'type': 'REGISTRY', 'domain': 'NCI Physician Data Query'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Androgen suppression + EBRT + Brachytherapy', 'description': 'Androgen suppression with external beam radiation therapy followed by brachytherapy boost', 'interventionNames': ['Drug: LHRH agonist', 'Drug: antiandrogen', 'Radiation: radiation therapy', 'Radiation: Brachytherapy boost']}], 'interventions': [{'name': 'LHRH agonist', 'type': 'DRUG', 'description': 'Lupron: 22.5mg IM injection q 12 wks x 2 OR Zoladex: 10.8 mg subQ injection q 12 wks x 2', 'armGroupLabels': ['Androgen suppression + EBRT + Brachytherapy']}, {'name': 'antiandrogen', 'type': 'DRUG', 'description': 'flutamide 250 mg PO tid for 4 wks OR casodex 50 mg PO daily for 4 wks', 'armGroupLabels': ['Androgen suppression + EBRT + Brachytherapy']}, {'name': 'radiation therapy', 'type': 'RADIATION', 'description': '4500 cGy total dose given days 1-5 for 5 weeks following initiation of androgen suppression (25 fractions)', 'armGroupLabels': ['Androgen suppression + EBRT + Brachytherapy']}, {'name': 'Brachytherapy boost', 'type': 'RADIATION', 'description': 'Iodine 125 0.3 to 0.5 U per seed OR palladium 103 1.04 to 1.4 U per seed as implant; prescribed dose of I-125 100 Gy (TG-43) and Pd-103 90 Gy', 'armGroupLabels': ['Androgen suppression + EBRT + Brachytherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19958', 'city': 'Lewes', 'state': 'Delaware', 'country': 'United States', 'facility': 'Beebe Medical Center', 'geoPoint': {'lat': 38.77456, 'lon': -75.13935}}, {'zip': '19718', 'city': 'Newark', 'state': 'Delaware', 'country': 'United States', 'facility': 'CCOP - Christiana Care Health Services', 'geoPoint': {'lat': 39.68372, 'lon': -75.74966}}, {'zip': '19805', 'city': 'Wilmington', 'state': 'Delaware', 'country': 'United States', 'facility': 'St. Francis Hospital', 'geoPoint': {'lat': 39.74595, 'lon': -75.54659}}, {'zip': '32803', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Hospital Cancer Institute at Florida Hospital Orlando', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '21921', 'city': 'Elkton MD', 'state': 'Maryland', 'country': 'United States', 'facility': 'Union Hospital Cancer Center at Union Hospital'}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber/Harvard Cancer Center at Dana Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02721', 'city': 'Fall River', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Hudner Oncology Center at Saint Anne's Hospital", 'geoPoint': {'lat': 41.70149, 'lon': -71.15505}}, {'zip': '01655', 'city': 'Worcester', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'UMASS Memorial Cancer Center - University Campus', 'geoPoint': {'lat': 42.26259, 'lon': -71.80229}}, {'zip': '65203', 'city': 'Columbia', 'state': 'Missouri', 'country': 'United States', 'facility': 'Ellis Fischel Cancer Center at University of Missouri - Columbia', 'geoPoint': {'lat': 38.95171, 'lon': -92.33407}}, {'zip': '64131', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'CCOP - Kansas City', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '63131', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Missouri Baptist Cancer Center', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Arch Medical Services, Incoroporated at Center for Cancer Care Research', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '89502', 'city': 'Reno', 'state': 'Nevada', 'country': 'United States', 'facility': 'Washoe Cancer Services at Washoe Medical Center - Reno', 'geoPoint': {'lat': 39.52963, 'lon': -119.8138}}, {'zip': '08103', 'city': 'Camden', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Cancer Institute of New Jersey at the Cooper University Hospital - Voorhees', 'geoPoint': {'lat': 39.92595, 'lon': -75.11962}}, {'zip': '14263', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Roswell Park Cancer Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '13057', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'CCOP - Syracuse Hematology-Oncology Associates of Central New York, P.C.', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'SUNY Upstate Medical University Hospital', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '13210', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Syracuse', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '13215', 'city': 'Syracuse', 'state': 'New York', 'country': 'United States', 'facility': 'Community General Hospital of Greater Syracuse', 'geoPoint': {'lat': 43.04812, 'lon': -76.14742}}, {'zip': '28233', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Presbyterian Cancer Center at Presbyterian Hospital', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27534', 'city': 'Goldsboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Wayne Memorial Hospital, Incorporated', 'geoPoint': {'lat': 35.38488, 'lon': -77.99277}}, {'zip': '28401', 'city': 'Wilmington', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Zimmer Cancer Center at New Hanover Regional Medical Center', 'geoPoint': {'lat': 34.23556, 'lon': -77.94604}}, {'zip': '27157', 'city': 'Winston-Salem', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Comprehensive Cancer Center at Wake Forest University', 'geoPoint': {'lat': 36.09986, 'lon': -80.24422}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'Arthur G. James Cancer Hospital and Solove Research Institute at Ohio State University', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '24541', 'city': 'Danville', 'state': 'Virginia', 'country': 'United States', 'facility': 'Danville Regional Medical Center', 'geoPoint': {'lat': 36.58597, 'lon': -79.39502}}], 'overallOfficials': [{'name': 'Mark Hurwitz, MD', 'role': 'STUDY_CHAIR', 'affiliation': "Dana-Farber/Brigham and Women's Cancer Center"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alliance for Clinical Trials in Oncology', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}