CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 339 enrolled
Drug / intervention
Triptorelin (Decapeptyl®)drug
Likely dose
Triptorelin (Decapeptyl®) 22.5mgfrom 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/NCT01020448
NCT01020448Phase 3Completed
CompareCT.gov

Prostate Cancer Antigen-3 (PCA-3) and TMPRSS2-ERG (T2-ERG) Score Changes During Initiation of Androgen Deprivation Therapy (ADT) With Triptorelin 22.5mg in Patients With Advanced Prostate Cancer (PCA): A Phase III, Single Arm Multicentre Study

Ipsen·interventional·Posted Nov 25, 2009·Updated Jan 30, 2019

In Brief

A Phase 3 clinical trial evaluating Triptorelin (Decapeptyl®) for Prostate Cancer. Completed, enrolled 339 participants across 59 sites in 10 countries.

Detailed Summary

The purpose of this study is to evaluate the effect of an initial hormonal treatment gonadotrophin-releasing hormone (GnRH Agonist) on 2 biomarkers (PCA3 and TMPRSS2-ERG), in patients with histologically confirmed and advanced stages of prostate cancer. Their characteristics, according to risk factors such as PSA and Gleason score will be determined at baseline and 1, 3 and 6 month post-treatment.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsProstate Cancer
CountriesBelgium, Denmark, France, Italy, Latvia, Lithuania, Netherlands, Romania, Spain, United Kingdom
Collaborators--

Timeline

Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedNov 25, 2009
Enrollment StartNov 1, 2009
Primary CompletionNov 1, 2011
Study CompletionJun 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 16.6 years ago

Interventions

Triptorelin (Decapeptyl®)drug

One intramuscular injection of triptorelin (Decapeptyl®) 22.5mg performed once all baseline procedures and assessments have been completed.