Ignite Creation Date:
2025-12-24 @ 11:53 PM
Ignite Modification Date:
2025-12-25 @ 9:48 PM
Study NCT ID:
NCT01076751
Status:
TERMINATED
Last Update Posted:
2011-02-14
First Post:
2010-02-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Observational Registry of Treatment Patterns in Castrate-resistant Prostate Cancer (CRPC) Patients
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 82}}, 'statusModule': {'whyStopped': 'delay in recruitment', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-02', 'completionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-02-11', 'studyFirstSubmitDate': '2010-02-25', 'studyFirstSubmitQcDate': '2010-02-25', 'lastUpdatePostDateStruct': {'date': '2011-02-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-02-26', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Overall survival', 'timeFrame': 'At Month 12 or death'}], 'secondaryOutcomes': [{'measure': 'Sequence of treatment in second-line, third-line', 'timeFrame': 'At Month 6 (+/- 2 months), Month 12 or death'}, {'measure': 'Characteristics and outcomes of patients who receive second-line taxane-based treatment compared to others', 'timeFrame': 'At baseline, Month 6 (+/- 2 months), Month 12 or death'}, {'measure': 'Indicators of health care resource utilization', 'timeFrame': 'At baseline, Month 6 (+/- 2 months), Month 12 or death'}, {'measure': 'Quality of life', 'timeFrame': 'At baseline, Month 6 (+/- 2 months) or Month 12'}]}, 'conditionsModule': {'conditions': ['Prostatic Neoplasms']}, 'descriptionModule': {'briefSummary': 'Primary Objective:\n\n* Describe real-life survival of CRPC patients who received first-line docetaxel and have disease progression\n\nSecondary Objective:\n\n* Describe treatment patterns\n* Describe the characteristics and outcomes of patients who received second-line taxane-based treatment compared to others\n* Describe economic and patient-reported outcomes'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with metastatic castrate-resistant prostate cancer', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion criteria:\n\n* Patients with CRPC progressing during the course of first line docetaxel-based chemotherapy or after at least 3 cycles (equivalent to 225mg/m2) of first line docetaxel-based chemotherapy\n* Patient who have given their written consent\n\nExclusion criteria:\n\n* Current participation in a clinical trial for the second-line treatment of prostate cancer\n* Patients having received less than 3 cycles of first line docetaxel-based chemotherapy and discontinued for a reason other than disease progression or toxicity\n* Patients having already started a second line treatment\n\nThe above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial."}, 'identificationModule': {'nctId': 'NCT01076751', 'acronym': 'PORTREAT', 'briefTitle': 'Observational Registry of Treatment Patterns in Castrate-resistant Prostate Cancer (CRPC) Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Sanofi'}, 'officialTitle': 'Observational Prospective Study of Survival, Treatment Patterns, Disease and Economic Outcomes in Patients With Metastatic Castrate-resistant Prostate Cancer (CRPC) With Progression During or After a First-line Docetaxel-based Regimen', 'orgStudyIdInfo': {'id': 'DIREG_C_05073'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'CRPC patients'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bridgewater', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 40.60079, 'lon': -74.64815}}, {'city': 'Paris', 'country': 'France', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'city': 'Frankfurt', 'country': 'Germany', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}, {'city': 'Barcelona', 'country': 'Spain', 'facility': 'Sanofi-Aventis Administrative Office', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Guildford Surrey', 'country': 'United Kingdom', 'facility': 'Sanofi-Aventis Administrative Office'}], 'overallOfficials': [{'name': 'Clinical Sciences & Operations', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sanofi'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sanofi', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Trial Transparency Team', 'oldOrganization': 'sanofi-aventis'}}}}