Efficacy and Safety of Leuprolide Acetate [amount hidden] Depot in Treatment of Prostate Cancer

What Was Tested

This registered phase 3 trial tested Leuprolide.

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

The registry classes the interventions as drug.

More on the Plan

The study duration will be 6 months.

Thirty(30) patients will be screened per protocol and enrolled at selected centers to form the PK cohort.

The PK/PD analysis will be performed using plasma specimens from the first 20 of 30 patients enrolled in the study (and included in the PK/PD cohort).

Patients not belonging to the PK cohort will be screened and enrolled per protocol and will follow the same study schedule as those enrolled in the PK portion of the study, except they will provide only sparse PK sampling.

Who Took Part

163 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: Males ≥18 years of age. 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., aspartate aminotransferase, alanine aminotransferase) ≤2.5 times the ULN for the clinical laboratory at Screening.

The full record lists 8 inclusion and 30 exclusion criteria; among the exclusions: excruciating, severe pain from extensive osseous deposits, taking into account medical history, clinical observations, and symptoms (rationale: see rationale in criterion 1); previous orchiectomy, adrenalectomy, or hypophysectomy (no washout allowed) (rationale: these therapies could have altered a patient's androgenic hormonal response); previous cancer systemic therapy such as chemotherapy, immunotherapy (e.g., antibody therapies, tumor vaccines), biological response modifiers (e.g., cytokines).

How the Study Was Run

Design: single-group and open-label.

Everyone knew when Leuprolide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2011-09 with completion listed for 2013-05.

It ran at 25 sites in United States (25).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Percentage of Participants Achieving Chemical Castration (Defined as Testosterone Levels ≤ 0.5 ng/mL) at Days 28, 84, and 168 (time frame: 168 days).

It also tracked 6 secondary outcomes, for example Determination of Serum Luteinizing Hormone (LH), Follicle-stimulating Hormone (FSH), Prostate-specific Antigen (PSA) Concentrations, Determination of Leuprolide Cmax, Safety Endpoints and Determination of Leuprolide Tmax.

What This Means in Plain Language

Put simply, this is a phase 3 trial of Leuprolide in 163 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

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