Study of Olaparib (± Degarelix) Given to Men With Intermediate/High Risk Prostate Cancer Before Prostatectomy

What Was Tested

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

Despite recent advances in the treatment of Castrate-Resistant Prostate Cancer (CRPC), there remains an unmet medical need to identify and optimise additional treatment for those patients with early prostate cancer who are at greatest risk of relapse following first-line treatment with curative intent.

This is a phase I study investigating the feasibility and tolerability of a short course of neoadjuvant treatment with olaparib, either as a monotherapy or in combination with degarelix) given in the window-of-opportunity prior to radical prostatectomy in men with early, localised intermediate-/high- risk prostate cancer.

It had two arms (groups): Group A (experimental) and Group B (experimental).

Olaparib Monotherapy.

Olaparib in combination with degarelix.

The registry classes the interventions as drug.

Who Took Part

The registry lists 20 actual participants took part.

It was open to men only aged from 18 years up to 73 years.

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

Examples of who could join: Have given written informed consent to participate\*. Men aged 18 years or over. Patients suitable for radical prostatectomy. ECOG performance status of 0 or 1. Access to archived diagnostic tissue or consent to undergo repeat biopsy, if necessary.

The full record lists 23 inclusion and 22 exclusion criteria; among the exclusions: contraindication to olaparib or degarelix; history of hypersensitivity to active or inactive excipients of olaparib; patients with known hypersensitivity to the degarelix active substance or mannitol must not receive degarelix.

How the Study Was Run

It was run as a randomized, parallel-group and open-label study.

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

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

Nothing was hidden in this open-label Degarelix study: the participants and staff both knew the treatment.

It started in 2016-12 with completion listed for 2019-05.

It ran at 1 site in United Kingdom.

Its stated primary purpose is other.

What Was Measured

Primary outcome: Determination of PARP Inhibition (time frame: Two week olaparib therapy (alone or in combination with degarelix)).

It also tracked 3 secondary outcomes, for example Incidence and Severity of Adverse Events and Feasibility of treatment approach.

What This Means in Plain Language

Put simply, this is a phase 1, randomized trial of Degarelix in 20 people.

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

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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