Ignite Creation Date:
2025-12-24 @ 3:01 PM
Ignite Modification Date:
2026-02-19 @ 4:16 AM
Study NCT ID:
NCT00540059
Status:
COMPLETED
Last Update Posted:
2007-10-05
First Post:
2007-10-03
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of QoL, Tolerability and Use of Zoladex 10,8 SafeSystem for Advanced PCa - German IPEP Trial
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': 'DEFINED_POPULATION'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1950}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-08', 'lastUpdateSubmitDate': '2007-10-04', 'studyFirstSubmitDate': '2007-10-03', 'studyFirstSubmitQcDate': '2007-10-04', 'lastUpdatePostDateStruct': {'date': '2007-10-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-10-05', 'type': 'ESTIMATED'}}, 'conditionsModule': {'keywords': ['Prostate carcinoma', 'LHRH', 'Zoladex'], 'conditions': ['Prostate Carcinoma']}, 'descriptionModule': {'briefSummary': 'Purpose of this study is the evaluation of QoL, tolerability and use of Zoladex 10,8 SafeSystem for advanced PCa under naturalistic conditions'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with PCa, who will be treated with Zoladex 10,8 SafeSystem based on the current SPC'}, 'identificationModule': {'nctId': 'NCT00540059', 'briefTitle': 'Evaluation of QoL, Tolerability and Use of Zoladex 10,8 SafeSystem for Advanced PCa - German IPEP Trial', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'Quality Assurance Project in Patients With Advanced Prostate Carcinoma - Evaluation of Tolerability, Quality of Life and Usage of Zoladex 10,8 SafeSystem', 'orgStudyIdInfo': {'id': 'Zx-002'}}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'H Brasch', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}}}}