Neoadjuvant Phase 2 Study Comparing the Effects of AR Inhibition With/Without SRC or MEK Inhibition in Prostate Cancer

What Was Tested

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

It had three arms (groups): AR inhibition only (active comparator), AR inhibition plus MEK inhibition (active comparator) and AR inhibition plus SRC inhibition (active comparator).

AR inhibition plus MEK inhibition Group 2: trametinib + degarelix + enzalutamide In Group 2, treatment with trametinib will begin on Day 29 (i.e. four weeks after initiation of androgen deprivation). Thus, trametinib will be administered for no less than two weeks and no more than four weeks.

AR inhibition plus SRC inhibition Group 3: dasatinib + degarelix + enzalutamide In Group 3, treatment with dasatinib will begin on Day 29 (i.e. four weeks after initiation of androgen deprivation). Thus, dasatinib will be administered for no less than two weeks and no more than four weeks.

The registry classes the interventions as drug.

More on the Plan

In addition, the researchers will use other medications in addition to hormone therapy in order to block some of the key biochemical steps that are thought to mediate treatment resistance.

Who Took Part

Enrollment: 45 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: Willing and able to give informed consent. Tumor accessible to biopsy. Age ≥ 18 years. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1. Estimated life expectancy of ≥ 6 months,.

The full record lists 17 inclusion and 42 exclusion criteria; among the exclusions: any non-adenocarcinoma histologic component,; any evidence of lymphatic or hematogenous metastases,; LVEF \< LLN.

How the Study Was Run

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

The participants were allocated by chance, so the Degarelix group and the comparison group should start out alike.

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

Being open-label, the Degarelix study did not mask who received what.

It started in 2014-09-23 with completion listed for 2024-09-23.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: N-cadherin and vimentin expression (time frame: Prostatectomy will occur during the 2 week "window" between 6 and 8 weeks after enrollment).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Degarelix in 45 people.

Its status is active not recruiting; no results are posted to the registry yet, so nothing here describes outcomes.

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