Overview

This trial is active, not recruiting.

Condition prostate cancer
Treatment triptorelin 11.25 mg
Phase phase 4
Sponsor Ipsen
Start date December 2012
End date June 2019
Trial size 226 participants
Trial identifier NCT01753297, A-38-52014-194

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

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
Triptorelin, powder and solvent for suspension (prolonged released form)
triptorelin 11.25 mg
Triptorelin, one injection every 3 months. A total of 3 injections (at baseline, 3 and 6 months)
(No Intervention)
Active surveillance after radical prostatectomy (RP)

Primary Outcomes

Measure
Biochemical Relapse-Free Survival (BRFS)
time frame: Every 3 months, up to 5 years

Secondary Outcomes

Measure
Event-Free Survival (EFS)
time frame: Every 3 months, up to 5 years
Overall Survival (OS)
time frame: Every 3 months, up to 5 years
Time to disease-specific mortality
time frame: Every 3 months, up to 5 years
PSA Doubling Time (PSADT)
time frame: Every 3 months, up to 5 years

Eligibility Criteria

Male participants at least 18 years old.

Inclusion Criteria: - Histopathologically confirmed adenocarcinoma of the prostate - Radical Prostatectomy with curative intent performed no more than 8 weeks before randomisation - High risk criteria of disease progression, defined as follows: Gleason score ≥8 on prostatectomy specimen, and/or Pre RP PSA level ≥20 ng/mL, and/or Primary tumour stage 3a (pT3a) (with any PSA level and any Gleason score) - Post-RP PSA levels ≤0.2 ng/mL at 6 weeks Exclusion Criteria: - Evidence of lymph nodes or distant metastasis - Positive margins - Evidence of any other malignant disease, not treated with a curative intent - Had surgical castration

Additional Information

Official title 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
Description This trial is a phase IV (in Russia and China) as approved indication is locally advanced or metastatic prostate cancer in both countries.
Trial information was received from ClinicalTrials.gov and was last updated in August 2016.
Information provided to ClinicalTrials.gov by Ipsen.