Efficacy and Safety Study of a New Leuprolide Acetate [amount hidden] Depot to Treat Prostate Cancer Patients

What Was Tested

In this phase 3 trial, researchers set out to test Leuprolide.

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

The registry classes the interventions as drug.

Who Took Part

20 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: Life expectancy of at least 1 year;. WHO/ECOG performance status of 0, 1, or 2;. Adequate renal function at screening as defined by serum creatinine \<= 1.6 times the upper limit of normal (ULN) for the clinical laboratory;. Adequate and stable hepatic function as defined by bilirubin \<= 1.5 times the ULN and transaminases (i.e. SGOT, SGPT) \<= 2.5 times the ULN for the clinical laboratory at screening;. Signed written informed consent prior to inclusion in the study.

The full record lists 7 inclusion and 32 exclusion criteria; among the exclusions: evidence of brain metastases, in the opinion of the investigator, taking into account medical history, clinical observations and symptoms;; evidence of spinal cord compression, in the opinion of the investigator, taking into account medical history, clinical observations and symptoms;; evidence of severe urinary tract obstruction with threatening urinary retention, in the opinion of the investigator, taking into account medical history, clinical observations and symptoms;.

How the Study Was Run

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

Being open-label, the Leuprolide 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 2008-05 with completion listed for 2009-04.

It ran at 8 sites in United States (8).

Its stated primary purpose is supportive care.

What Was Measured

The main thing measured (primary outcome): Percent of successful patients achieving chemical castration (time frame: Days 28, 84, and 168).

It also tracked 10 secondary outcomes, for example WHO/ECOG performance status, Serum LH concentration (mIU/mL), Serum FSH concentration (mIU/mL), Serum PSA concentration (ng/mL), Frequency of bone pain and plasma testosterone concentration (ng/mL) in PK population.

What This Means in Plain Language

Put simply, this is a phase 3, non-randomized trial of Leuprolide in 20 people.

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

It ended early (terminated); no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Leuprolide compound page, all human trials.