Induction and Maintenance of Castration After Subcutaneous Injections of Triptorelin Pamoate in Patients With Prostate Cancer

What Was Tested

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

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

The registry classes the interventions as drug.

Who Took Part

126 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: Histologically proven locally advanced or metastatic prostate cancer who are suitable for androgen deprivation therapy. Male aged ≥18 years old. Screening testosterone level of \>125 ng/dL. Life expectancy of greater than 12 months in the judgement of the Investigator. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.

The full record lists 7 inclusion and 18 exclusion criteria; among the exclusions: prior hormonal therapy for prostate cancer; presence or history of any other malignancy except for non melanoma skin cancer adequately treated at least 2 years before study entry; painful local bone lesions or spinal lesions which may lead to compression.

How the Study Was Run

The set-up was single-group and open-label.

Everyone knew when Triptorelin was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

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

It started in 2013-01 with completion listed for 2013-10.

It ran at 12 sites in Bulgaria (4), Poland (3), Latvia (2), Romania (2) and France (1).

Its stated primary purpose is treatment.

What Was Measured

It also tracked 13 secondary outcomes, for example Probability of Testosterone <50 ng/dL, Time to Achieve Castration (Tcast), Plasma Triptorelin Levels (Cmin), Percentage Change in Prostate Specific Antigen (PSA) Levels From Baseline in All Subjects, Percentage of Subjects With Normal and Abnormal PSA Levels at Day 183 (End of Study Visit) and Clinically Apparent Tumor Progression.

What This Means in Plain Language

Put simply, this is a phase 3 trial of Triptorelin in 126 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.