Effects of Triptorelin Pamoate 6-month When Given to Adult Chinese Participants With Advanced Cancer in the Prostate

What Was Tested

This registered phase 3 trial tested Triptorelin.

Participants will receive 1 injection of triptorelin pamoate 6-month formulation.

It had 1 arm (groups): one (experimental).

The registry classes the interventions as drug.

Who Took Part

The registry lists 195 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 capable of giving signed informed consent. Participant must be over 18 years of age, at the time of signing the informed consent. Has a histologically or cytologically confirmed adenocarcinoma, locally advanced or metastatic prostate cancer. Or participant has PSA recurrence after curative treatment and be a candidate for androgen deprivation therapy (ADT). Has expected survival time ≥12 months according to the investigator's assessment. Has Eastern Cooperative Oncology Group (ECOG) performance status score ≤1.

The full record lists 6 inclusion and 18 exclusion criteria; among the exclusions: risk of a serious complication in the case of tumour flare; presence of another neoplastic lesion or brain metastases; metastatic hormone-sensitive prostate cancer with high tumour burden.

How the Study Was Run

Design: 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 2022-11-17 with completion listed for 2024-08-20.

It ran at 36 sites in China (36).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Percentage of Participants Who Achieved Castrate Levels of Serum Testosterone on Day 29 (time frame: Day 29). Percentage of Participants Who Maintained the Castrate Levels From Week 8 to Week 24 (time frame: From Week 8 to Week 24).

It also tracked 11 secondary outcomes, for example Percent Change From Baseline in Prostate Specific Antigen (PSA) at Weeks 12 and 24, Time to Maximum Observed Plasma Concentration (Tmax) of Triptorelin Pamoate, Maximum Observed Plasma Concentration (Cmax) of Triptorelin Pamoate, Area Under the Plasma Concentration Time Curve From Time 0 to the Visit on Day 169 (AUC0-169) of Triptorelin Pamoate, Area Under the Plasma Concentration Time Curve From Time 0 to the Last Quantifiable Concentration (AUClast) of Triptorelin Pamoate and Time to Maximum Observed Plasma Concentration of Testosterone.

What This Means in Plain Language

Put simply, this is a phase 3 trial of Triptorelin in 195 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.