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A Multicentric, Multinational (China and Russia), Randomised, Open, Controlled Study of Immediate 9 Months Adjuvant Hormone Therapy With Triptorelin 11.25 mg Versus Active Surveillance After Radical Prostatectomy in High Risk Prostate Cancer Patients
The purpose of this study is to assess the benefit of immediate hormonal treatment after Radical Prostatectomy in Chinese and Russian patients with high risk prostate cancer. To reach this target, the trial will compare a group of patients treated with triptorelin at 8 weeks after the surgery and for a duration of 9 months (3 injections) versus another group (called "active surveillance group") who will be not receiving triptorelin. Both groups will be followed every 3 months to monitor any sign of disease progression during a minimum of 36 months
This trial is a phase IV (in Russia and China) as approved indication is locally advanced or metastatic prostate cancer in both countries.
Age
18 - No limit years
Sex
MALE
Healthy Volunteers
No
Chinese PLA General HospitalDepartment of UrologySite #156007
Beijing, China
Peiking University First Hospital Site #156011
Beijing, China
West China Hosspital, Sichuan UniversityDepartment of Urology Site #156008
Chengdu, China
The First Affiliated Hospital of the 3th Military Medical University of PLA (Southwest Hospital) Site # 156010
Chongqing, China
SUN YAT-SEN Cancer Center Department of Site #156009
Guangzhou, China
The third hospital affiliated to Sun Yat-sen University Site #156005
Guangzhou, China
The first hospital affiliated to medical school of Zhejiang university Site #156001
Hangzhou, China
Fudan University cancer hospital Site #156003
Shanghai, China
First Affiliated Hospital of the Fourth Military Medical University Site #156004
Xi'an, China
SIH Altaian Territorial Oncological Dispensary Site #643006
Barnaul, Russia
Start Date
December 11, 2012
Primary Completion Date
September 9, 2019
Completion Date
September 9, 2019
Last Updated
December 9, 2020
226
ACTUAL participants
Triptorelin 11.25 mg
DRUG
Lead Sponsor
Ipsen
NCT06842498
NCT04550494
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.
View ClinicalTrials.gov Terms and ConditionsNCT05691465