Study to Assess the Non-inferiority of Pamorelin® [amount hidden] SC Injected Versus Pamorelin® [amount hidden] IM Injected in Patients Suffering From Advanced Prostate Cancer (PAMOJECT)

What Was Tested

In this phase 2 trial, researchers set out to test Triptorelin.

Triptorelin is a substitute for a natural hormone produced in the body called Gonadotrophin-releasing hormone (GnRH).

GnRH is a hormone secreted by hypothalamus (a gland located in brain) and controls the production of sex hormones (eg testosterone in men) in other organs in the body.

It had two arms (groups): 1 (experimental) and 2 (active comparator).

The registry classes the interventions as drug.

Who Took Part

The registry lists 25 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: Histological proven prostate cancer, locally advanced or metastatic and scheduled to receive hormonal deprivation therapy. Life expectancy of more than 9 months. Documented testosterone levels of ≥ 125 ng/dl measured by any laboratory or on site within the previous 6 months.

The full record lists 3 inclusion and 5 exclusion criteria; among the exclusions: has a history of hypersensitivity to the investigational medicinal product or drugs with a similar chemical structure; has previously received a gnrh analogue, estrogens or a steroidal anti -androgen within the last year preceding the study; concomitant anti-coagulation treatment.

How the Study Was Run

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

Random assignment meant chance, not the researchers, decided who got Triptorelin and who got the comparison, which limits bias.

The Triptorelin group and the comparison group ran side by side rather than switching.

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.

It started in 2007-02 with completion listed for 2008-02.

It ran at 15 sites in Netherlands (15).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percentage of patients achieving a plasma testosterone level ≤ [amount hidden]/dl ([amount hidden]/l).

It also tracked 3 secondary outcomes, for example Patient acceptability of the injection; the pain experienced during injection, scored by means of a Visual Analogue Scale (VAS) and Care giver acceptability of the administration of the injection by means of a Visual Analogue Scale (VAS).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Triptorelin in 25 people.

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

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

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