Ignite Creation Date:
2025-12-24 @ 7:24 PM
Ignite Modification Date:
2026-01-02 @ 12:42 AM
Study NCT ID:
NCT00003903
Status:
COMPLETED
Last Update Posted:
2013-10-16
First Post:
1999-11-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Androgen Suppression on Bone Loss in Patients With or Without Bone Metastases Secondary to Prostate Cancer
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010024', 'term': 'Osteoporosis'}, {'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'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': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'primaryPurpose': 'SUPPORTIVE_CARE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-10', 'completionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-10-14', 'studyFirstSubmitDate': '1999-11-01', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2013-10-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-08', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['stage I prostate cancer', 'stage IIB prostate cancer', 'stage IIA prostate cancer', 'stage III prostate cancer', 'stage IV prostate cancer', 'osteoporosis'], 'conditions': ['Osteoporosis', 'Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Assessing the effect of androgen suppression on bone loss in prostate cancer patients may improve the ability to plan treatment, may decrease the risk of fractures and bony pain, and may help patients live more comfortably.\n\nPURPOSE: Clinical trial to determine the effect of androgen suppression on bone loss in patients who have prostate cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Evaluate the effect of androgen ablation on bone resorption in patients with or without bone metastases secondary to prostate cancer.\n\nOUTLINE: Patients are stratified according to prior androgen ablation therapy (yes vs no) and metastatic disease (yes vs no).\n\nPatients undergo blood work and 24 hour urine collection on day 1 and at week 6-8. Patients who have received androgen ablation therapy and are found to have increased bone resorption undergo a dual energy x-ray absorptiometry (DEXA) scan.\n\nA comparison is made between androgen ablation therapy and bone resorption and if metastases are associated with the two.\n\nPROJECTED ACCRUAL: A total of 150 patients will be accrued for this study within 9 months.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed prostate cancer\n* Stratum 1 (androgen ablation therapy):\n\n * Bone metastases\n * Prior orchiectomy allowed\n * Prior or concurrent leuprolide and/or goserelin therapy allowed\n* Stratum 2 (androgen ablation therapy):\n\n * No bone metastases\n * Prior orchiectomy allowed\n * Prior or concurrent leuprolide and/or goserelin therapy allowed\n* Stratum 3 (no androgen ablation therapy):\n\n * No metastatic disease\n * Prior flutamide or bicalutamide therapy allowed\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* Not specified\n\nPerformance status:\n\n* Not specified\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* Calcium normal\n\nHepatic:\n\n* Not specified\n\nRenal:\n\n* Not specified\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy:\n\n* Not specified\n\nChemotherapy:\n\n* See Disease Characteristics\n\nEndocrine therapy:\n\n* See Disease Characteristics\n* No concurrent high dose steroids\n\nRadiotherapy:\n\n* Prior radiotherapy allowed\n\nSurgery:\n\n* See Disease Characteristics\n* Prior radical prostatectomy allowed\n\nOther:\n\n* No concurrent bisphosphonates'}, 'identificationModule': {'nctId': 'NCT00003903', 'briefTitle': 'Effect of Androgen Suppression on Bone Loss in Patients With or Without Bone Metastases Secondary to Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Rochester'}, 'officialTitle': 'An Evaluation of the Effect of Androgen Ablation on Bone Resorption in Prostate Cancer Patients', 'orgStudyIdInfo': {'id': 'CDR0000067078'}, 'secondaryIdInfos': [{'id': 'P30CA011198', 'link': 'https://reporter.nih.gov/quickSearch/P30CA011198', 'type': 'NIH'}, {'id': 'URCC-U2898'}, {'id': 'NCI-G99-1522'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'management of therapy complications', 'type': 'PROCEDURE'}]}, 'contactsLocationsModule': {'locations': [{'zip': '14642-0001', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'James P. Wilmot Cancer Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}], 'overallOfficials': [{'name': 'Deepak M. Sahasrabudhe, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'James P. Wilmot Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Rochester', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}