Ignite Creation Date:
2025-12-25 @ 2:28 AM
Ignite Modification Date:
2025-12-30 @ 12:28 PM
Study NCT ID:
NCT00003734
Status:
UNKNOWN
Last Update Posted:
2016-07-21
First Post:
1999-11-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination Hormone Therapy Followed by 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': 'D005485', 'term': 'Flutamide'}, {'id': 'D017329', 'term': 'Triptorelin Pamoate'}, {'id': 'D011878', 'term': 'Radiotherapy'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D007987', 'term': 'Gonadotropin-Releasing Hormone'}, {'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': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'TREATMENT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 276}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '1998-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-12', 'lastUpdateSubmitDate': '2016-07-20', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2003-12-08', 'lastUpdatePostDateStruct': {'date': '2016-07-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-12-09', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['adenocarcinoma of the prostate', 'stage I prostate cancer', 'stage IIB prostate cancer', 'stage IIA prostate cancer', 'stage III prostate cancer', 'stage IV prostate cancer'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'references': [{'pmid': '20797824', 'type': 'RESULT', 'citation': "Armstrong JG, Gillham CM, Dunne MT, Fitzpatrick DA, Finn MA, Cannon ME, Taylor JC, O'Shea CM, Buckney SJ, Thirion PG. A randomized trial (Irish clinical oncology research group 97-01) comparing short versus protracted neoadjuvant hormonal therapy before radiotherapy for localized prostate cancer. Int J Radiat Oncol Biol Phys. 2011 Sep 1;81(1):35-45. doi: 10.1016/j.ijrobp.2010.04.065. Epub 2010 Aug 25."}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Hormone therapy using triptorelin and flutamide may fight cancer by reducing the production of androgens. It is not yet known whether giving hormone therapy for 4 months is more effective than giving therapy for 8 months prior to radiation therapy for prostate cancer.\n\nPURPOSE: Randomized phase III trial to study the effectiveness of combination hormone therapy for 4 or 8 months followed by radiation therapy in treating patients with prostate cancer.', 'detailedDescription': 'OBJECTIVES: I. Compare the efficacy of 4 months vs 8 months of luteinizing hormone-releasing hormone (LHRH) agonist therapy combined with antiandrogen therapy prior to radiotherapy, in terms of disease-free survival and overall survival, in patients with stage I-IV localized invasive prostate cancer.\n\nOUTLINE: This is a randomized study. Patients are randomized to one of two treatment arms. All patients receive triptorelin IM once a month and oral flutamide three times daily with meals. Patients randomized to arm I receive this therapy regimen for 4 months. Patients randomized to arm II receive this therapy regimen for 8 months. All patients then undergo radiotherapy 5 days a week for 7 weeks within 2 months of the last injection of triptorelin and within 1 month of the last oral flutamide tablet. Patients are followed every 3 months after radiotherapy.\n\nPROJECTED ACCRUAL: A total of 276 patients (138 per treatment arm) will be accrued for this study.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS: Histologically confirmed invasive adenocarcinoma of the prostate Stage I or II (PSA greater than 20 or Gleason score at least 7) OR Stage III or IV (any PSA, any Gleason) Histologically confirmed benign nodal status No distant metastases\n\nPATIENT CHARACTERISTICS: Age: 18 and over Performance status: Karnofsky 60-100% Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Not specified Renal: Not specified Other: No other prior malignancy except nonmelanoma skin cancer No other uncontrolled illness that would prevent compliance\n\nPRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: No prior or other concurrent hormonal therapy Radiotherapy: Not specified Surgery: No prior treatment other than transurethral prostatectomy No prior orchiectomy'}, 'identificationModule': {'nctId': 'NCT00003734', 'briefTitle': 'Combination Hormone Therapy Followed by Radiation Therapy in Treating Patients With Prostate Cancer', 'organization': {'class': 'NIH', 'fullName': 'National Cancer Institute (NCI)'}, 'officialTitle': 'A Randomised Comparison of Short and Protracted Neoadjuvant Hormonal Therapy Prior to Radiation Therapy of High Risk Localized Prostate Cancer', 'orgStudyIdInfo': {'id': 'CDR0000066849'}, 'secondaryIdInfos': [{'id': 'ICORG-97-01'}, {'id': 'EU-98060'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'flutamide', 'type': 'DRUG'}, {'name': 'triptorelin', 'type': 'DRUG'}, {'name': 'radiation therapy', 'type': 'RADIATION'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cork', 'country': 'Ireland', 'facility': 'Cork University Hospital', 'geoPoint': {'lat': 51.89797, 'lon': -8.47061}}, {'city': 'Donnegal', 'country': 'Ireland', 'facility': 'Letterkenny Hospital'}, {'zip': '4', 'city': 'Dublin', 'country': 'Ireland', 'facility': "St. Vincent's Hospital", 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'zip': '6', 'city': 'Dublin', 'country': 'Ireland', 'facility': "Saint Luke's Hospital", 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'zip': '7', 'city': 'Dublin', 'country': 'Ireland', 'facility': 'Mater Misericordiae Hospital', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'zip': '8', 'city': 'Dublin', 'country': 'Ireland', 'facility': 'Adelaide and Meath Hospital', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'zip': '9', 'city': 'Dublin', 'country': 'Ireland', 'facility': 'Beaumont Hospital', 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'city': 'Galway', 'country': 'Ireland', 'facility': 'Bon Secours Hospital', 'geoPoint': {'lat': 53.27245, 'lon': -9.05095}}, {'city': 'Galway', 'country': 'Ireland', 'facility': 'Galway University Hospital', 'geoPoint': {'lat': 53.27245, 'lon': -9.05095}}, {'city': 'Limerick', 'country': 'Ireland', 'facility': 'Regional Hospital - Limerick', 'geoPoint': {'lat': 52.66472, 'lon': -8.62306}}, {'city': 'Sligo', 'country': 'Ireland', 'facility': 'Sligo General', 'geoPoint': {'lat': 54.26969, 'lon': -8.46943}}, {'zip': 'BT8 8JR', 'city': 'Belfast', 'state': 'Northern Ireland', 'country': 'United Kingdom', 'facility': 'Belfast City Hospital Trust Incorporating Belvoir Park Hospital', 'geoPoint': {'lat': 54.59682, 'lon': -5.92541}}], 'overallOfficials': [{'name': 'John Gerard Armstrong, MD, MB, MRCPI', 'role': 'STUDY_CHAIR', 'affiliation': "Saint Luke's Hospital"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "St. Luke's Hospital, Ireland", 'class': 'OTHER'}}}}