Study to Evaluate a Subcutaneous Four Months Sustained-release Formulation of Triptorelin in Patients With Prostate Cancer

What Was Tested

In this phase 3 trial, researchers set out to test Triptorelin.

To identify the proportion of patients remaining medically castrated (testosterone level \< 50 ng/dL) on Day 240 following two administrations of a 4-month sustained-release (SR) formulation of triptorelin.

The registry classes the interventions as drug.

Who Took Part

100 planned participants were the target.

It was open to men only aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Patient must be 18 years old or over. Patient must have a histologically-confirmed diagnosis of locally advanced or metastatic prostate cancer or presenting a relapse after curative treatment which is amenable to androgen deprivation therapy. Patient must have an estimated survival time of greater than 8 months according to the investigator's assessment.

The full record lists 4 inclusion and 4 exclusion criteria; among the exclusions: patient who underwent a previous surgical castration; prostate cancer therapy within 2 months of baseline visit; patient with testosterone level below 150 ng/dl at screening.

How the Study Was Run

The set-up was non-randomized, single-group and open-label.

Being open-label, the Triptorelin study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2006-11 with completion listed for 2007-10.

It ran at 31 sites in France (12), Belgium (5), Poland (4), Latvia (3), Lithuania (3) and Ukraine (2).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Proportion of patients with testosterone serum levels maintained below the castration threshold of 50 ng/dL (time frame: Day 240).

It also tracked 6 secondary outcomes, for example Proportion of patients with testosterone serum levels maintained below the castration threshold of 50 ng/dL, Proportion of patients with testosterone serum levels maintained below the castration threshold of 20 ng/dL, Time to achieve castration in days post treatment (Tlag), Time to escape from castration (Texit), Tlag and Texit confirmed by two consecutive measurements taken 1 week apart and Duration of castration in days (Tcast) Changes in PSA levels.

What This Means in Plain Language

Put simply, this is a phase 3, non-randomized trial of Triptorelin in 100 people.

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Triptorelin compound page, all human trials.