Effects of Triptorelin When Given Every 6-months Under the Skin to Adult Males With Cancer in the Prostate

What Was Tested

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

It had 1 arm (groups): Triptorelin embonate (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 147 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: Participant is male and must be 18 years of age inclusive, at the time of signing the informed consent. Has Eastern Cooperative Oncology Group (ECOG) performance status score of 0 to 1. Has a life expectancy of \>18 months. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.

The full record lists 8 inclusion and 15 exclusion criteria; among the exclusions: presence of another neoplastic lesion or brain metastases; metastatic hormone-sensitive prostate cancer with high tumour burden; metastatic castration-resistant prostate cancer.

How the Study Was Run

The set-up was 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 2022-08-30 with completion listed for 2024-07-08.

It ran at 39 sites in France (11), Spain (8), Germany (5), Belgium (4), Lithuania (4) and Netherlands (4).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percentage of Participants Who Maintained Castrate Levels of Serum Testosterone During the Study (time frame: Up to Day 337).

It also tracked 6 secondary outcomes, for example Percentage of Participants Castrated on Days 29, 85, 141, 169, 253, 309 and 337, Percentage of Participants Castrated on Days 3 and 7 After Each Injection Administered on Days 1 and 169, Percent Change From Baseline in Prostate Specific Antigen (PSA) at Days 169 and 337 and Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and TEAEs of Local Intolerance.

What This Means in Plain Language

Put simply, this is a phase 3 trial of Triptorelin in 147 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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