Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 10:14 PM
Study NCT ID:
NCT01560858
Status:
COMPLETED
Last Update Posted:
2019-01-25
First Post:
2012-03-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Treatment Patterns Among Patients With Prostate Cancer Prior to Diagnosis of a Castration-resistant State
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': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 407}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-24', 'studyFirstSubmitDate': '2012-03-20', 'studyFirstSubmitQcDate': '2012-03-21', 'lastUpdatePostDateStruct': {'date': '2019-01-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-03-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prior treatment before progression to advanced or metastatic disease.', 'timeFrame': 'Baseline', 'description': 'Number of participants with each category of treatment.'}, {'measure': 'Treatment of advanced or metastatic disease.', 'timeFrame': 'Baseline', 'description': 'Number of participants with each category of treatment.'}], 'secondaryOutcomes': [{'measure': 'Clinical management of Castration-Resistant Prostate Cancer (CRPC) patients in the clinical practice.', 'timeFrame': 'Baseline', 'description': 'Percentage of specialists (urologist, radiotherapist, oncologist or other specialist) in charge of treatment decision in CRPC patients.'}, {'measure': 'Number of CRPC patients with signs and symptoms of metastatic disease.', 'timeFrame': 'Baseline'}, {'measure': 'Time to castration resistant state after beginning of hormonotherapy.', 'timeFrame': 'Baseline'}, {'measure': 'Demographic data.', 'timeFrame': 'Baseline'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Prostate Cancer']}, 'descriptionModule': {'briefSummary': 'The purpose of the protocol is to describe treatment patterns among patients with prostate cancer prior to diagnosis of castration-resistant state.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Community sample', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Patients with prostate cancer who had developed a castration resistant state in the last 24 months prior to starting the study\n* Patient must give written informed consent before any study related procedure\n\nExclusion Criteria:\n\n* Patients with medical histories lacking data required to evaluate the study objectives'}, 'identificationModule': {'nctId': 'NCT01560858', 'briefTitle': 'Treatment Patterns Among Patients With Prostate Cancer Prior to Diagnosis of a Castration-resistant State', 'organization': {'class': 'INDUSTRY', 'fullName': 'Ipsen'}, 'officialTitle': 'A Retrospective Observational Study to Describe Treatment Patterns Among Patients With Prostate Cancer Prior to Diagnosis of a Castration-resistant State, in Routine Clinical Practice in Spain.', 'orgStudyIdInfo': {'id': 'A-92-52014-196'}}, 'contactsLocationsModule': {'locations': [{'city': 'Valencia', 'country': 'Spain', 'facility': 'Private practice, La Cañada, Paterna', 'geoPoint': {'lat': 39.47391, 'lon': -0.37966}}], 'overallOfficials': [{'name': 'Ipsen Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ipsen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ipsen', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}