Ignite Creation Date:
2025-12-24 @ 4:09 PM
Ignite Modification Date:
2026-01-03 @ 6:29 PM
Study NCT ID:
NCT00118066
Status:
TERMINATED
Last Update Posted:
2015-05-27
First Post:
2005-07-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Calcitriol in Preventing Prostate Cancer in Patients With Prostatic Intraepithelial Neoplasia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011230', 'term': 'Precancerous Conditions'}, {'id': 'D011471', 'term': 'Prostatic Neoplasms'}], 'ancestors': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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': 'D002117', 'term': 'Calcitriol'}, {'id': 'D019370', 'term': 'Observation'}], 'ancestors': [{'id': 'D004100', 'term': 'Dihydroxycholecalciferols'}, {'id': 'D006887', 'term': 'Hydroxycholecalciferols'}, {'id': 'D002762', 'term': 'Cholecalciferol'}, {'id': 'D002782', 'term': 'Cholestenes'}, {'id': 'D002776', 'term': 'Cholestanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'id': 'D013261', 'term': 'Sterols'}, {'id': 'D014807', 'term': 'Vitamin D'}, {'id': 'D012632', 'term': 'Secosteroids'}, {'id': 'D008563', 'term': 'Membrane Lipids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D008722', 'term': 'Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'whyStopped': 'Slow accruaL, lack of scientific progress', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2004-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-22', 'studyFirstSubmitDate': '2005-07-08', 'studyFirstSubmitQcDate': '2005-07-08', 'lastUpdatePostDateStruct': {'date': '2015-05-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-07-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Presence of prostate intraepithelial neoplasia after 16 weeks', 'timeFrame': '4 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['prostate cancer', 'high grade prostatic intraepithelial neoplasia'], 'conditions': ['Precancerous/Nonmalignant Condition', 'Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'RATIONALE: Chemoprevention is the use of certain drugs to keep cancer from forming, growing, or coming back. The use of calcitriol may prevent prostate cancer. It is not yet known whether calcitriol is more effective than observation in preventing prostate cancer.\n\nPURPOSE: This randomized phase II trial is studying how well calcitriol works in preventing prostate cancer in patients with prostatic intraepithelial neoplasia.', 'detailedDescription': 'OBJECTIVES:\n\n* Determine the effects of calcitriol in patients with high-grade prostatic intraepithelial neoplasia.\n* Determine the toxicity of this drug in these patients.\n* Determine the effect of this drug on prostate specific antigen in these patients.\n\nOUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 arms.\n\n* Arm I: Patients receive oral calcitriol once daily for 8 weeks. Treatment repeats every 8 weeks for 2 courses in the absence of unacceptable toxicity.\n\nAfter completion of course 2 (week 16), patients undergo biopsy. Patients continue to receive calcitriol for up to 3 additional weeks while the biopsy is being evaluated. Patients with persistent high-grade prostatic intraepithelial neoplasia (HGPIN) by biopsy receive 2 additional courses of calcitriol. Patients with no HGPIN or prostate cancer by biopsy are removed from the study.\n\n* Arm II: Patients undergo observation for 16 weeks. At week 16, patients undergo biopsy. Patients with persistent HGPIN by biopsy receive 2 courses of calcitriol as in arm I. Patients with no HGPIN or prostate cancer by biopsy are removed from the study.\n\nAfter completion of study treatment, patients are followed annually for 2 years.\n\nPROJECTED ACCRUAL: A total of 50 patients (25 per arm) will be accrued for this study.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'DISEASE CHARACTERISTICS:\n\n* Histologically confirmed high-grade prostatic intraepithelial neoplasia\n\n * Diagnosed within the past 6 months\n* No evidence of prostate cancer within the past 6 months\n* No evidence of palpable nodules on digital rectal exam\n* Prostate specific antigen ≤ 10 ng/mL within the past 3 months\n\nPATIENT CHARACTERISTICS:\n\nAge\n\n* 18 and over\n\nPerformance status\n\n* ECOG 0-1\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* SGOT and SGPT ≤ 1.5 times upper limit of normal\n\nRenal\n\n* No uncontrolled renal failure\n* No cancer-related hypercalcemia or kidney stones within the past 5 years\n\nCardiovascular\n\n* No uncontrolled coronary artery disease\n* No uncontrolled congestive heart failure\n\nOther\n\n* Prior malignancy allowed provided patient was curatively treated and has been disease-free for an appropriate time period for the specific cancer\n* No known HIV positivity\n* No active infection\n* No major depression or suicidal ideation\n* No other condition that would preclude study compliance\n* No other uncontrolled medical condition\n\nPRIOR CONCURRENT THERAPY:\n\nBiologic therapy\n\n* Not specified\n\nChemotherapy\n\n* No prior chemotherapy for any malignancy\n\nEndocrine therapy\n\n* At least 2 weeks since prior and no concurrent finasteride (Prosear® or Propecia®) or other androgen suppressor\n* No concurrent corticosteroids\n\nRadiotherapy\n\n* Not specified\n\nSurgery\n\n* Not specified\n\nOther\n\n* At least 2 weeks since prior phenytoin or phenobarbital\n* At least 2 weeks since prior ketoconazole\n* No concurrent administration of any of the following:\n\n * Magnesium-containing antacids\n * Thiazide diuretics\n * Calcium supplements\n * Digoxin\n * Herbal supplements\n * Pharmacological doses of cholecalciferol (vitamin D) or its derivatives'}, 'identificationModule': {'nctId': 'NCT00118066', 'briefTitle': 'Calcitriol in Preventing Prostate Cancer in Patients With Prostatic Intraepithelial Neoplasia', 'organization': {'class': 'OTHER', 'fullName': 'Rutgers, The State University of New Jersey'}, 'officialTitle': 'A Randomized Phase II Trial Of Calcitriol In Patients With Prostatic Intraepithelial Neoplasia', 'orgStudyIdInfo': {'id': '080404'}, 'secondaryIdInfos': [{'id': 'P30CA072720', 'link': 'https://reporter.nih.gov/quickSearch/P30CA072720', 'type': 'NIH'}, {'id': 'CDR0000433508', 'type': 'OTHER', 'domain': 'NIH'}, {'id': '0220044901', 'type': 'OTHER', 'domain': 'CINJ IRB'}, {'id': 'CINJ-NJ3803'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm I', 'description': 'Patients receive oral calcitriol once daily for 8 weeks. Treatment repeats every 8 weeks for 2 courses. After completion of course 2 (week 16), patients undergo biopsy. Patients continue to receive calcitriol for up to 3 additional weeks while the biopsy is being evaluated. Patients with persistent high-grade prostatic intraepithelial neoplasia (HGPIN) by biopsy receive 2 additional courses of calcitriol.', 'interventionNames': ['Dietary Supplement: calcitriol']}, {'type': 'OTHER', 'label': 'Arm II', 'description': 'Patients undergo observation for 16 weeks. At week 16, patients undergo biopsy. Patients with persistent HGPIN by biopsy receive 2 courses of calcitriol as in arm I.', 'interventionNames': ['Dietary Supplement: calcitriol', 'Procedure: observation']}], 'interventions': [{'name': 'calcitriol', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Given orally', 'armGroupLabels': ['Arm I', 'Arm II']}, {'name': 'observation', 'type': 'PROCEDURE', 'description': 'No initial intervention', 'armGroupLabels': ['Arm II']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08816', 'city': 'East Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Central Jersey Oncology Center, PA - East Brunswick', 'geoPoint': {'lat': 40.42788, 'lon': -74.41598}}, {'zip': '07962', 'city': 'Morristown', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Carol G. Simon Cancer Center at Morristown Memorial Hospital', 'geoPoint': {'lat': 40.79677, 'lon': -74.48154}}, {'zip': '08903', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Cancer Institute of New Jersey at UMDNJ - Robert Wood Johnson Medical School', 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '08903', 'city': 'New Brunswick', 'state': 'New Jersey', 'country': 'United States', 'facility': "Saint Peter's University Hospital", 'geoPoint': {'lat': 40.48622, 'lon': -74.45182}}, {'zip': '07901', 'city': 'Summit', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Overlook Hospital', 'geoPoint': {'lat': 40.71562, 'lon': -74.36468}}], 'overallOfficials': [{'name': 'Robert S. DiPaola, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rutgers Cancer Institute of New Jersey'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rutgers, The State University of New Jersey', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Cancer Institute (NCI)', 'class': 'NIH'}, {'name': 'Rutgers Cancer Institute of New Jersey', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}