Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-25 @ 9:27 PM
Study NCT ID:
NCT00036556
Status:
COMPLETED
Last Update Posted:
2007-08-15
First Post:
2002-05-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of Atrasentan in Men With Non-Metastatic, Hormone-Refractory 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': 'D000077868', 'term': 'Atrasentan'}], 'ancestors': [{'id': 'D052117', 'term': 'Benzodioxoles'}, {'id': 'D004149', 'term': 'Dioxoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D011759', 'term': 'Pyrrolidines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 941}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-08', 'lastUpdateSubmitDate': '2007-08-13', 'studyFirstSubmitDate': '2002-05-10', 'studyFirstSubmitQcDate': '2002-05-10', 'lastUpdatePostDateStruct': {'date': '2007-08-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2002-05-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Time-to-disease progression will be determined by the time to onset of the earliest of one of the following events: New skeletal lesions, new metastatic extra-skeletal lesions, or an event due to metastatic prostate cancer.', 'timeFrame': 'Every 12 weeks'}]}, 'conditionsModule': {'keywords': ['Hormone-Refractory Prostate Cancer'], 'conditions': ['Prostatic Neoplasms']}, 'descriptionModule': {'briefSummary': 'This study is being done to evaluate the safety and efficacy of atrasentan in men with non-metastatic hormone-refractory prostate cancer.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Have been diagnosed with prostate cancer.\n* Have a rising PSA while on hormone therapy or following surgical castration.\n\nExclusion Criteria:\n\n* Have evidence of distant metastatic disease on screening bone scan or CT scan.\n* Have received cytotoxic chemotherapy.\n* Have received opioid or narcotic medications (such as codeine or morphine) or radiation for pain caused by your prostate cancer in the last 6 months.'}, 'identificationModule': {'nctId': 'NCT00036556', 'briefTitle': 'Study of Atrasentan in Men With Non-Metastatic, Hormone-Refractory Prostate Cancer', 'nctIdAliases': ['NCT00026455'], 'organization': {'class': 'INDUSTRY', 'fullName': 'Abbott'}, 'officialTitle': 'A Phase III, Randomized Study of Atrasentan in Men With Non-Metastatic, Hormone-Refractory Prostate Cancer', 'orgStudyIdInfo': {'id': 'M00-244'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Atrasentan', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '35205', 'city': 'Homewood', 'state': 'Alabama', 'country': 'United States', 'facility': 'Urology Centers Of Alabama', 'geoPoint': {'lat': 33.47177, 'lon': -86.80082}}, {'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Alaska Clinical Research Center, LLC', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '85712', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Advanced Clinical Trials', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'Arkansas Urologial Associates, PA', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '91910', 'city': 'Chula Vista', 'state': 'California', 'country': 'United States', 'facility': 'Robin V. 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'Colorado', 'country': 'United States', 'facility': 'Urology Associate, Pc', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '33180', 'city': 'Aventura', 'state': 'Florida', 'country': 'United States', 'facility': 'South Fl Medical Research', 'geoPoint': {'lat': 25.95648, 'lon': -80.13921}}, {'zip': '33916', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Clinical Physiology Associates', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '34652', 'city': 'New Port Richey', 'state': 'Florida', 'country': 'United States', 'facility': 'Advanced Research Institute', 'geoPoint': {'lat': 28.24418, 'lon': -82.71927}}, {'zip': '34237', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Dattoli Cancer Center', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Urology Treatment Center', 'geoPoint': {'lat': 27.33643, 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'Dreyer Medical Clinic', 'geoPoint': {'lat': 41.76058, 'lon': -88.32007}}, {'zip': '60611-3010', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University Medical School', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60631', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Progressive Care, S.C.', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60637-1470', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Christopher Ryan, MD', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60640', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Weiss Memorial Hospital', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60201', 'city': 'Evanston', 'state': 'Illinois', 'country': 'United States', 'facility': 'Evanston Hospital Kellogg Cancer Center', 'geoPoint': {'lat': 42.04114, 'lon': -87.69006}}, {'zip': '47713', 'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'facility': 'Welborn Clinic', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'zip': '47714-0981', 'city': 'Evansville', 'state': 'Indiana', 'country': 'United States', 'facility': 'Welborn Clinic -East', 'geoPoint': {'lat': 37.97476, 'lon': -87.55585}}, {'zip': '52807', 'city': 'Davenport', 'state': 'Iowa', 'country': 'United States', 'facility': 'Urologic Associates, Pc', 'geoPoint': {'lat': 41.52364, 'lon': -90.57764}}, {'zip': '50309', 'city': 'Des Moines', 'state': 'Iowa', 'country': 'United States', 'facility': 'Iowa Urology', 'geoPoint': {'lat': 41.60054, 'lon': -93.60911}}, {'zip': '66160-7390', 'city': 'Kansas City', 'state': 'Kansas', 'country': 'United States', 'facility': 'Kansas University Medical Center', 'geoPoint': {'lat': 39.11417, 'lon': -94.62746}}, {'zip': '71106', 'city': 'Shreveport', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Regional Urology', 'geoPoint': {'lat': 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'facility': 'Billings Oncology Associates', 'geoPoint': {'lat': 45.78329, 'lon': -108.50069}}, {'zip': '68198-7860', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska Medical Center', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '89509', 'city': 'Reno', 'state': 'Nevada', 'country': 'United States', 'facility': 'Nevada Urology Associate', 'geoPoint': {'lat': 39.52963, 'lon': -119.8138}}, {'zip': '87131', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'UNM Medical Center', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '12208-3499', 'city': 'Albany', 'state': 'New York', 'country': 'United States', 'facility': 'Albany Medical Center South Clinical Campus', 'geoPoint': {'lat': 42.65258, 'lon': -73.75623}}, {'zip': '11235', 'city': 'Brooklyn', 'state': 'New York', 'country': 'United States', 'facility': 'HemOnCare, PC', 'geoPoint': {'lat': 40.6501, 'lon': -73.94958}}, {'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Beth Israel Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10960', 'city': 'Nyack', 'state': 'New York', 'country': 'United States', 'facility': 'Nyack Hospital', 'geoPoint': {'lat': 41.09065, 'lon': -73.91791}}, {'zip': '27599-7235', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'The University Of North Carolina At Chapel Hill', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}, {'zip': '28203', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Blumenthal Cancer Center', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '28204', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Mckay Urology', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '28207', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Urology Specialists Of The Carolinas', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27401', 'city': 'Greensboro', 'state': 'North Carolina', 'country': 'United States', 'facility': 'The Urology Center', 'geoPoint': {'lat': 36.07264, 'lon': -79.79198}}, {'zip': '45267-0589', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'University Of Cincinnati Medical Center', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '74104-5433', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Urologic Specialists Of Oklahoma, Inc.', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}, {'zip': '97401', 'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Urology Specialists', 'geoPoint': {'lat': 44.05207, 'lon': 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