Neoadjuvant Degarelix With or Without Apalutamide (ARN-509) Followed by Radical Prostatectomy

What Was Tested

The trial (phase 2) is built around Degarelix.

There is no evidence yet of a survival impact of LHRH antagonist (LHRHa) +/- new-generation anti-androgens in this setting.

Thus novel studies are needed to assess this treatment combination.

It had two arms (groups): ARN-509 + degarelix (experimental) and placebo + degarelix (active comparator).

Treatment period of 12 weeks before RP + PLND.

Treatment period of 12 weeks before RP + PLND.

The registry classes the interventions as drug and other.

More on the Plan

PRIMARY OBJECTIVE: To assess the difference in antitumor effect between the treatment arms by measuring MRD following radical prostatectomy.

Who Took Part

90 actual participants took part.

It was open to men only aged from 18 years up to 80 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Before patient registration/randomization, written informed consent must be given according to ICH/GCP, and national/local regulations. Male aged 18 years or older (within 80 years). Histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features. Diagnosis of intermediate (at least 2 of the following factors: cT2b, biopsy GS 7, PSA 10-20ng/ml) or high-risk prostatic adenocarcinoma (clinical stage≥T2c and/or biopsy GS≥8 and/or PSA\>20ng/ml), cN0-cN1, cM0. Patient amenable for open or robotic radical prostatectomy + pelvic lymph node dissection.

The full record lists 14 inclusion and 12 exclusion criteria; among the exclusions: previous surgical/endoscopic treatments for prostatic disease; cm1 disease; any contraindication for pet or mr investigations.

How the Study Was Run

The set-up was randomized, parallel-group and quadruple-blind.

Because people in this Degarelix study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Degarelix.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2019-03-28 with completion listed for 2021-07-01.

It ran at 1 site in Belgium.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Minimal Residual Disease (MRD) (time frame: After 12 weeks of neoadjuvant therapy + RP + PLND).

It also tracked 26 secondary outcomes, for example Difference in proportions of pathological downstage, Complete pathological response rates, Difference in proportions of patients with pN1 disease, Proteins expression in prostatic tumour TMA's (tissue microarrays), Transcriptome analysis by microarray expression platform and Pathway profiling and Gene Set Enrichment Analyses.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Degarelix in 90 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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