Dose Finding Study of BKM 120 in Combination With LH-RH Agonists and Bicalutamide in Men With Non Castrate Metastatic Prostate Cancer

What Was Tested

In this phase 1 trial, researchers set out to test Buserelin.

It had three arms (groups): one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as drug.

More on the Plan

Metastases are rare at the time of diagnosis but may occur after failure of local treatment (SEER).

Recommended treatment for non castrate metastatic prostate cancer (NCMPC) is castration by orchiectomy or medical castration by LH-RH (luteinizing hormone-releasing hormone) agonists alone and or combined androgen blockage with LH-RH agonists and anti androgen.

However, most patients showing an initial response to hormonal therapy for advanced prostate cancer will progress to a castration-resistant phase of the disease with a much poorer prognosis.

Understanding the mechanisms of resistance to AR and identifying directed new therapies is a real challenge in this situation.

Who Took Part

The registry lists 6 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: Signed Informed Consent Form (ICF) prior to screening. Male patients (≥ 18 years). WHO performance status ≤ 2. Histologically-confirmed adenocarcinoma of the prostate. Patients with non castrate metastatic prostate cancer, with radiological metastatic disease ; patients with metastatic disease is documented on a Pet-Scan to choline is also eligible.

The full record lists 19 inclusion and 26 exclusion criteria; among the exclusions: patients eligible for this study must not meet any of the following criteria:; patient has received previous treatment with pi3k and/or mtor inhibitors; ADT \> 3 months.

How the Study Was Run

The set-up was non-randomized, single-group and open-label.

Being open-label, the Buserelin 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 2014-10 with completion listed for 2017-11.

It ran at 1 site in France.

Its stated primary purpose is treatment.

What This Means in Plain Language

Put simply, this is a phase 1, non-randomized trial of Buserelin in 6 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 Buserelin compound page, all human trials.