Pharmacokinetics of Degarelix in Chinese Patients With Prostate Cancer

What Was Tested

The trial (phase 1) is built around Degarelix.

The purpose of this trial is to look at how much a new trial drug get into body, such as when the drug concentration in your body reaches peak and how high the peak value is.

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

The registry classes the interventions as drug.

Who Took Part

The registry lists 15 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: Has a histologically confirmed (Gleason graded) adenocarcinoma of the prostate (all stages), for which endocrine therapy (except for neoadjuvant hormonal therapy) is indicated. Has a Prostate-specific Antigen (PSA) level ≥2.0 ng/mL at Screening. Has a screening serum testosterone level \>150 ng/dL. Has an Eastern Cooperative Oncology Group (ECOG) score of ≤2.

The full record lists 4 inclusion and 5 exclusion criteria; among the exclusions: is considered to be candidate for curative therapy, i.e. radical prostatectomy or radiotherapy; is in need of neoadjuvant hormonal therapy; has a history of bilateral orchiectomy, adrenalectomy, or hypophysectomy.

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 2015-07 with completion listed for 2016-10-13.

It ran at 1 site in China.

Its stated primary purpose is basic science.

What Was Measured

The main thing measured (primary outcome): Maximum plasma concentration observed (Cmax) (time frame: Day 0 - 196). Time of Cmax after subcutaneous administration (Tmax) (time frame: Day 0 - 196). Maximum plasma concentration observed (Cmax) (time frame: Day 0 - 28).

It also tracked 1 secondary outcome, for example Plasma trough levels of degarelix.

What This Means in Plain Language

Put simply, this is a phase 1 trial of Degarelix in 15 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.