Leuprolide Acetate [amount hidden] Depot to Treat Prostate Cancer

What Was Tested

This registered phase 3 trial tested Leuprolide.

The registry classes the interventions as drug.

More on the Plan

These patients will belong to pre-defined study sites.

Who Took Part

The registry lists 120 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: Life expectancy of at least 1 year. World Health Organization/Eastern Cooperative Oncology Group (WHO/ECOG) performance status of 0, 1, or 2. Adequate renal function at screening as defined by serum creatinine \</= 1.6 times the ULN (upper limit of normal) 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 30 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

The set-up was non-randomized, single-group and open-label.

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 2005-09 with completion listed for 2007-11.

It ran at 28 sites in United States (15), Czechia (4), Hungary (2), Italy (2), Austria (1) and Germany (1).

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): to determine the proportion of patients maintaining castration levels of plasma testosterone from week 4 to study end. Safety: evaluation of the safety of the new formulation based on adverse events (AEs), local tolerability, vital signs, electrocardiograms (ECGs), and clinical parameters.

What This Means in Plain Language

Put simply, this is a phase 3, non-randomized trial of Leuprolide in 120 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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