Degarelix Neo-Adjuvant Radical Prostatectomy Trial

What Was Tested

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

To assess the effect of neo-adjuvant GnRH antagonist, degarelix, versus LHRH agonist on intratumoral levels of androgens.

It had three arms (groups): Degarelix (experimental), Degarelix + Casodex (experimental) and LHRH Agonist + Casodex (active comparator).

Degarelix Alone.

Degarelix and Casodex.

LHRH Agonist and Casodex.

The registry classes the interventions as drug.

Who Took Part

The registry lists 35 actual participants took part.

It was open to men only aged from 18 years up to 75 years.

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

Examples of who could join: Men \>18 and =\< 75 years of age. Willing and able to provide informed consent, either alone or with the aid of a translator. Histologically confirmed prostate cancer as determined by transrectal ultrasound (TRUS) guided prostate biopsy performed within 6 months of study enrolment. Gleason Score \>= 7and/or prostate cancer that is clinical stage T2 disease. Candidates for open radical prostatectomy considered surgically resectable by urologic evaluation.

The full record lists 7 inclusion and 15 exclusion criteria; among the exclusions: history of receiving radiation to the pelvic area; history of bilateral orchiectomy, adrenalectomy, or hypophysectomy; history of severe untreated asthma, anaphylactic reactions, or severe urticaria and/or angioedema.

How the Study Was Run

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

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.

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

It started in 2012-08 with completion listed for 2014-12.

It ran at 2 sites in Canada (2).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Intratumoral androgen levels (time frame: Week 12).

It also tracked 1 secondary outcome, for example Prostate tumour morphology related to androgen withdrawal after neo-adjuvant therapy.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Degarelix in 35 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.