Effect of Triptorelin (Decapeptyl®) [amount hidden] on Two Biomarkers in Patients With Advanced Prostate Cancer

What Was Tested

The trial (phase 3) is built around Triptorelin.

The purpose of this study is to evaluate the effect of an initial hormonal treatment gonadotrophin-releasing hormone (GnRH Agonist) on 2 biomarkers (PCA3 and TMPRSS2-ERG), in patients with histologically confirmed and advanced stages of prostate cancer.

Their characteristics, according to risk factors such as PSA and Gleason score will be determined at baseline and 1, 3 and 6 month post-treatment.

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

The registry classes the interventions as drug.

Who Took Part

Enrollment: 339 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: A histologically confirmed, locally advanced or metastatic prostate cancer, and naïve to androgen deprivation therapy, and a candidate for hormonal treatment. An estimated survival time of at least twelve months according to the investigator's assessment. A performance status score ≤ 2 according to the World Health Organisation (WHO) criteria.

The full record lists 3 inclusion and 4 exclusion criteria; among the exclusions: previous surgical castration; previous or has planned curative prostate cancer therapy (radiation/surgery); previous hormone therapy (gnrh analogues, estrogens or anti-androgens).

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 2009-11 with completion listed for 2011-11.

It ran at 59 sites in France (15), United Kingdom (11), Spain (8), Belgium (6), Denmark (4) and Netherlands (4).

Its stated primary purpose is diagnostic.

What Was Measured

Primary outcome: PCA3 Score Expressed as a Ratio of PCA3 mRNA (Messenger Ribonucleic Acid) Over PSA (Prostate Specific Antigen) mRNA (time frame: At month 6 post-treatment).

It also tracked 5 secondary outcomes, for example PCA3 Score Expressed as a Ratio of PCA3 mRNA Over PSA mRNA, TMPRSS2-ERG Score (Expressed as a Ratio of T2-ERG mRNA Over PSA mRNA), Proportion of Patients Medically Castrated (i.e. With Serum Testosterone Levels of <50 ng/dL), PSA Level and Safety, Assessed Through the Collection of Adverse Events (AEs).

What This Means in Plain Language

Put simply, this is a phase 3 trial of Triptorelin in 339 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.