Ignite Creation Date:
2025-12-25 @ 2:30 AM
Ignite Modification Date:
2025-12-30 @ 10:03 AM
Study NCT ID:
NCT01123434
Status:
COMPLETED
Last Update Posted:
2015-01-08
First Post:
2010-05-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Immediate Postoperative Adjuvant Hormonal Treatment in High Risk Localised or Locally Advanced Prostate Cancer 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': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-01', 'completionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-01-07', 'studyFirstSubmitDate': '2010-05-10', 'studyFirstSubmitQcDate': '2010-05-12', 'lastUpdatePostDateStruct': {'date': '2015-01-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the efficacy of immediate postoperative adjuvant hormonal treatment according to 2 year PSA recurrence rate in high risk localised or locally advanced Chinese prostate cancer patients.', 'timeFrame': 'Up to 2 years'}], 'secondaryOutcomes': [{'measure': 'To assess the quality of life（QoL）of the high risk localised or locally advanced Chinese prostate cancer patients with immediate postoperative adjuvant hormonal treatment.', 'timeFrame': 'Up to 2 years'}, {'measure': 'Get the information of immediate postoperative adjuvant hormonal treatment (including the regimen, dosage and duration).', 'timeFrame': 'Up to 2 years'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['prostate cancer', 'adjuvant', 'hormonal'], 'conditions': ['2 Years PSA Recurrence Rate']}, 'descriptionModule': {'briefSummary': 'The primary objective is to assess the efficacy of immediate postoperative adjuvant hormonal treatment according to 2 year PSA recurrence rate in high risk localised or locally advanced Chinese prostate cancer patients.The secondary objective is to assess the quality of life（QoL）of the high risk localised or locally advanced Chinese prostate cancer patients with immediate postoperative adjuvant hormonal treatment and get the information of immediate postoperative adjuvant hormonal treatment (including the regimen, dosage and duration).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients form urology surgery', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Localised with one of any high recurrence risk factors(Gleason score≥8 or preoperative serum PSA≥20ng/ml), or locally advanced(T≥pT3、N0M0 and any T、N（+）M0 ) Chinese prostate cancer patients confirmed histologically through radical prostatectomy either with laparoscopy or laparotomy within 1 month after surgery. Before the patient recruitment, the investigator has decided to prescribe immediate postoperative adjuvant hormonal treatment to the patient according to the Chinese routine practice.\n* Provision of written informed consent prior to any study specific procedures.\n\nExclusion Criteria:\n\n* Patients must not enter the study if any of the following exclusion criteria are fulfilled\n* Have used neoadjuvant hormonal treatment prior to the surgery.'}, 'identificationModule': {'nctId': 'NCT01123434', 'briefTitle': 'Immediate Postoperative Adjuvant Hormonal Treatment in High Risk Localised or Locally Advanced Prostate Cancer Patients.', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Non-interventional Study of Immediate Postoperative Adjuvant Hormonal Treatment in High Risk Localised or Locally Advanced Chinese Prostate Cancer Patients.', 'orgStudyIdInfo': {'id': 'NIS-OCN-DUM-2009/2'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'Localised with one of any high recurrence risk factors, or locally advanced Chinese prostate cancer patients confirmed histologically through radical prostatectomy either with laparoscopy or laparotomy within 1 month after surgery. Before the patient recruitment, the investigator has decided to prescribe immediate postoperative adjuvant hormonal treatment to the patient according to the Chinese routine practice.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Guangzhou', 'state': 'Guangdong', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Xi’an', 'state': 'Shanxi', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 35.99785, 'lon': 113.52486}}, {'city': 'Chengdu', 'state': 'Sichuan', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 30.66667, 'lon': 104.06667}}, {'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'city': 'Shanghai', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}, {'city': 'Tianjin', 'country': 'China', 'facility': 'Research Site', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'overallOfficials': [{'name': 'Karen Atkin', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AstraZeneca'}, {'name': 'Yanjing Zhang', 'role': 'STUDY_CHAIR', 'affiliation': 'AstraZeneca'}, {'name': 'Prof. Na', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Peking University Shougang Hospital'}, {'name': 'Prof. Ye', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tong Ji Hospital of Tongji Medical College of Huazhong University of Science and Technology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}