Ignite Creation Date:
2025-12-26 @ 10:17 PM
Ignite Modification Date:
2025-12-26 @ 10:17 PM
Study NCT ID:
NCT00022412
Status:
COMPLETED
Last Update Posted:
2019-12-13
First Post:
2001-08-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Doxercalciferol Before Surgery in Treating 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': 'C042533', 'term': '1 alpha-hydroxyergocalciferol'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2008-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-11', 'studyFirstSubmitDate': '2001-08-10', 'studyFirstSubmitQcDate': '2003-01-26', 'lastUpdatePostDateStruct': {'date': '2019-12-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2003-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intermediate endpoint biomarker modulation', 'timeFrame': '18 months'}, {'measure': 'Toxicity', 'timeFrame': '30 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['adenocarcinoma of the prostate', 'stage I prostate cancer', 'stage II prostate cancer'], 'conditions': ['Prostate Cancer']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://cancer.wisc.edu/', 'label': 'University of Wisconsin Carbone Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'RATIONALE: Doxercalciferol may be an effective way to treat localized prostate cancer before surgery.\n\nPURPOSE: Randomized phase II trial to study the effectiveness of giving doxercalciferol before surgery in treating patients who have localized prostate cancer.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine whether doxercalciferol modulates intermediate endpoint biomarkers in the development of prostate cancer in patients with localized prostate cancer.\n* Assess the toxicity of this drug in these patients.\n\nOUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to one of 2 arms.\n\n* Arm I: Patients receive doxercalciferol once daily for 28 days. Patients then undergo prostatectomy.\n* Arm II: Patients undergo observation for 28 days. Patients then undergo prostatectomy.\n\nPROJECTED ACCRUAL: A total of 60 patients (30 per arm) will be accrued for this study within 18 months.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically or cytologically confirmed localized adenocarcinoma of the prostate\n* Candidate for prostatectomy\n\nPATIENT CHARACTERISTICS:\n\nAge:\n\n* 21 and over\n\nPerformance status:\n\n* Not specified\n\nLife expectancy:\n\n* Not specified\n\nHematopoietic:\n\n* WBC at least 4,000/mm\\^3\n* Platelet count at least 100,000/mm\\^3\n\nHepatic:\n\n* Bilirubin no greater than 1.4 mg/dL\n* AST no greater than 3 times normal\n\nRenal:\n\n* Creatinine no greater than 2.0 mg/dL\n* Calcium no greater than 10.2 mg/dL\n* No idiopathic urinary calcium stone disease\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 for prostate cancer\n* No concurrent hormonal therapy, including luteinizing hormone-releasing hormone agonists, antiandrogens, glucocorticoids, ketoconazole, finasteride, diethylstilbestrol, or progestins\n\nRadiotherapy:\n\n* No prior brachytherapy or external beam radiotherapy for prostate cancer\n\nSurgery:\n\n* See Disease Characteristics\n\nOther:\n\n* At least 7 days since prior vitamin D therapy or calcium supplements\n* No other concurrent vitamin D analogues or calcium supplements\n* No concurrent magnesium-containing antacids\n* No concurrent thiazide-containing diuretics\n* No concurrent phenytoin, phenobarbital, glutethimide, digoxin, or digitalis'}, 'identificationModule': {'nctId': 'NCT00022412', 'briefTitle': 'Doxercalciferol Before Surgery in Treating Localized Prostate Cancer', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Phase II Open Label, Multi-Center Clinical Trial Of Modulation Of Intermediate Endpoint Biomarkers By 1x-Hydroxyvitamin D2 In Patients With Clinically Localized Prostate Cancer And High Grade PIN', 'orgStudyIdInfo': {'id': 'CO99802'}, 'secondaryIdInfos': [{'id': 'P30CA014520', 'link': 'https://reporter.nih.gov/quickSearch/P30CA014520', 'type': 'NIH'}, {'id': 'WCCC-CO-99802'}, {'id': 'NCI-N01-CN-95130'}, {'id': 'WCCC-CO-2000169'}, {'id': 'NCI-P01-0188'}, {'id': 'CDR0000068813', 'type': 'OTHER'}, {'id': '2000-595', 'type': 'OTHER', 'domain': 'Institutional Review Board'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Observation, then prostatectomy', 'description': 'Arm 2: Patients undergo observation for 28 days. Patients then undergo prostatectomy.', 'interventionNames': ['Procedure: conventional surgery']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Doxercalciferol once daily for 28 days', 'description': 'Dietary supplement once daily to treat prostate cancer for 28 days', 'interventionNames': ['Dietary Supplement: doxercalciferol']}], 'interventions': [{'name': 'doxercalciferol', 'type': 'DIETARY_SUPPLEMENT', 'otherNames': ['Localized adenocarcinoma of the prostate'], 'description': 'Arm 1: Patients receive doxercalciferol once daily for 28 days. Patients then undergo prostatectomy.', 'armGroupLabels': ['Doxercalciferol once daily for 28 days']}, {'name': 'conventional surgery', 'type': 'PROCEDURE', 'otherNames': ['Prostatectomy - no dietary supplement'], 'description': 'Procedure: Prostatectomy for prostate cancer', 'armGroupLabels': ['Observation, then prostatectomy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52242-1002', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'Holden Comprehensive Cancer Center at University of Iowa', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '14642', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'James P. Wilmot Cancer Center at University of Rochester Medical Center', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '53705', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Veterans Affairs Medical Center - Madison', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '53715', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Meriter Hospital', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '53792-6164', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin Comprehensive Cancer Center', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}, {'zip': '53226-3596', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin Cancer Center', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'George Wilding, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Wisconsin, Madison'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}