GP Extended Action Triptorelin

What Was Tested

In this phase 4 trial, researchers set out to test Goserelin and Triptorelin.

The study will also aim to answer whether both doctors and patients would prefer treatment with a 6-monthly injection rather than injections every 3 months.

It had two arms (groups): one (experimental) and Current 3-monthly LHRH agonist (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 27 actual participants took part.

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: Patients must give written (personally signed and dated) informed consent before completing any study related procedure. Patients must be 18 years old or over. Patients must have a documented diagnosis of locally advanced or metastatic prostate cancer suitable for hormonal treatment. Patients must be medically castrated with serum testosterone ≤ 0.5ng/mL. Patients must have received at least two injections of a 3- monthly LHRH agonist by the time of the screening tests.

The full record lists 10 inclusion and 10 exclusion criteria; among the exclusions: patients are, in the opinion of the investigator, unable to comply fully with the protocol and the study instructions; patients currently taking additional anti-androgen therapy as part of an active hormonal control therapy; patients scheduled to receive palliative radiotherapy during the course of the study.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The participants were allocated by chance, so the Goserelin group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Nothing was hidden in this open-label Goserelin study: the participants and staff both knew the treatment.

It started in 2012-08 with completion listed for 2014-02.

It ran at 35 sites in United Kingdom (35).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percentage of Participants Maintaining Biochemical Castration (time frame: 6 months).

It also tracked 6 secondary outcomes, for example Percentage of Participants Maintaining Biochemical Castration After 12 Months of Treatment, Change From Baseline in Quality of Life Using EuroQol 5 Dimensions 5 Levels [EQ-5D-5L] Questionnaire, Change From Baseline in Patient Satisfaction With Medication Using Treatment Satisfaction Questionnaire for Medication (TSQM Version II), Patient Satisfaction With Treatment and Percentage of Participants Who Changed Injection Frequency After Completion of the Study.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Goserelin and Triptorelin in 27 people.

Its size is small, so on its own it can only give an early look.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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