CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 226 enrolled
Drug / intervention
Triptorelin 11.25 mgdrug
Likely dose
Triptorelin 11.25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01753297
NCT01753297Phase 4Completed

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

Ipsen·interventional·Posted Dec 20, 2012·Updated Dec 9, 2020

In Brief

A Phase 4 clinical trial evaluating Triptorelin 11.25 mg for Prostate Cancer. Completed, enrolled 226 participants across 18 sites in 2 countries.

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesChina, Russia
Collaborators--

Timeline

Phase 4CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedDec 20, 2012
Enrollment StartDec 11, 2012
Primary CompletionSep 9, 2019
TodayJul 2, 2026
Enrollment to primary: 6.7 yearsPosted 13.5 years ago

Interventions

Triptorelin 11.25 mgdrug

Triptorelin, one injection every 3 months. A total of 3 injections (at baseline, 3 and 6 months)