Phase IV Study to Evaluate Bone Mineral Density in No-bone Metastatic Prostate Cancer Treated With Degarelix

What Was Tested

This registered phase 4 trial tested Degarelix.

The aim of this phase IV interventional study is to evaluate variation in bone mineral density and lean and fat body composition in patients with prostate cancer without bone metastasis, treated with Degarelix.

These variations are evaluated at time 0 (before starting androgen deprivation therapy with Degarelix) and after 12 months of therapy by dual-energy X-ray absorptiometry (DXA scan).

It had 1 arm (groups): Degarelix (experimental).

The registry classes the interventions as drug.

More on the Plan

Whereas the consequences of initial GnRH agonist on BMD and body composition are well characterized, less is known regarding the effects of GnRH antagonists.

At the best of their knowledge the changes in body composition induced by Degarelix in prostate cancer patients has never been explored.

Dual-energy X-ray absorptiometry (DXA) is a reliable and accurate method to determine the changes in body composition in patients with prostate cancer (PCa) undergoing androgen deprivation therapy (ADT).

This study is designed to obtain explorative information on changes in bone mineral density, fat body mass and lean body mass by DXA scan after administration of Degarelix.

Who Took Part

35 planned participants were the target.

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: Male outpatients, aged 18 or older, willing and able to provide written informed consent;. Histological diagnosis of prostate carcinoma;. More than 6-month survival prospect;. No bone metastases as assessed by bone scintigraphy;. Eligibility to ADT with Degarelix in the opinion of the clinical investigator.

The full record lists 5 inclusion and 12 exclusion criteria; among the exclusions: patients with absolute or relative contraindication for prescription of degarelix. in particular:; hypersensitivity towards any component of firmagon®; patients with history of or risk factors for torsades de pointes.

How the Study Was Run

Design: single-group and open-label.

Being open-label, the Degarelix 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 2017-06-26 with completion listed for 2019-03.

It ran at 1 site in Italy.

Its stated primary purpose is other.

What Was Measured

The main thing measured (primary outcome): Changes in fat body mass (time frame: 12 months).

It also tracked 6 secondary outcomes, for example changes in bone mineral density, changes in lean body mass, changes in fasting serum lipids, changes in bone turn-over markers, changes in insulin sensitivity and changes in serum follicle stimulating hormone (FSH) levels.

What This Means in Plain Language

Put simply, this is a phase 4 trial of Degarelix in 35 people.

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

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.