Pilot Study to Evaluate the Effects of a Generic Goserelin Acetate in Patients With Prostate Cancer

What Was Tested

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

It had 1 arm (groups): Goserelin acetate Injection (experimental).

The registry classes the interventions as drug.

More on the Plan

A 12 week (84 day) single injection study in 12 patients with carcinoma of the prostate.

During the screening phase, all patients will come to the clinic for a screening visit (V1), during which the patient's eligibility will be evaluated and baseline assessments will be performed.

Eligible patients will sign the informed consent form at this visit.

Monitoring of the effects for approximate 4h after the injection will be performed.

Who Took Part

11 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: Be male at least 18 years of age. Have a life expectancy of at least 1 year. Have the ability to understand the requirements of the study and is willing to provide written informed consent. Agree to abide by the study restrictions and return for the required assessments. Only patients who can be discontinued safety from contra-indicated medications discussed in section 7.4 of the protocol can be included in the study.

The full record lists 7 inclusion and 18 exclusion criteria; among the exclusions: have brain metastases; have vertebral metastases with evidence of spinal cord compression; have renal impairment due to ureteric obstruction or a history of obstructive uropathy.

How the Study Was Run

Design: single-group and open-label.

Being open-label, the Goserelin 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 2017-02-21 with completion listed for 2017-12-06.

It ran at 7 sites in Canada (5) and Georgia (2).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): Changes in testosterone levels (time frame: 84 days).

It also tracked 2 secondary outcomes, for example Changes in PSA and # of treatment emergent adverse events occurring.

What This Means in Plain Language

Put simply, this is a early phase 1 trial of Goserelin in 11 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 Goserelin compound page, all human trials.