Intramuscular Injections of Degarelix Administered in 1-Month Dosing Regimens in Patients With Prostate Cancer

What Was Tested

The trial (phase 2) is built around Degarelix.

It had three arms (groups): Degarelix - Cohort 1 (experimental), Degarelix - Cohort 2 (experimental) and Degarelix - Cohort 3 (experimental).

(gonadotrophin-releasing hormone (GnRH) receptor blocker).

(gonadotrophin-releasing hormone (GnRH) receptor blocker).

(gonadotrophin-releasing hormone (GnRH) receptor blocker).

The registry classes the interventions as drug.

Who Took Part

The registry lists 76 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 adenocarcinoma of the prostate, for which endocrine therapy is indicated. Has a current tumour, nodule and metastasis (TNM) staging within 12 weeks prior to treatment start and, if clinically indicated a bone scan. Has a PSA level meeting one of these criteria:. For treatment-naïve patients: Screening PSA level should be ≥2 ng/mL. For patients with recurrence after radiotherapy or cryotherapy: Patients should have a serum PSA (two measurements) to be \>2 ng/mL higher than a previously confirmed PSA nadir.

The full record lists 9 inclusion and 8 exclusion criteria; among the exclusions: has had previous or is currently under hormonal management of prostate cancer; is considered to be a candidate for curative therapy i.e. radical prostatectomy or radiotherapy during the trial period; has a history of bilateral orchiectomy, adrenalectomy, or hypophysectomy.

How the Study Was Run

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

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.

The Degarelix group and the comparison group ran side by side rather than switching.

Being open-label, the Degarelix study did not mask who received what.

It started in 2012-01 with completion listed for 2012-11.

It ran at 15 sites in United States (9) and Canada (6).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Plasma degarelix PK profile (blood sample analysis): measured by (Cmax, AUC, Tmax) (time frame: Day 0-28 and at Day 112-140). Trough plasma levels (blood sample analysis) (time frame: Day 28, 56, 84, 112, 140, 168 and 196).

It also tracked 11 secondary outcomes, for example Proportion of patients with testosterone ≤0.5 ng/mL, Serum levels of testosterone and PSA, Percentage change in PSA levels, Changes in patient-reported injection site pain (VAS scores over time), Incidence and severity of investigator-evaluated injection site reactions and Cumulative probabilities of suppressing testosterone to castrate level (≤0.5 ng/mL) by visit.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Degarelix in 76 people.

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.