A Study of Leuprolide to Treat Prostate Cancer

What Was Tested

This registered phase 3 trial tested Leuprolide.

It had two arms (groups): Leuprolide acetate - Formulation A (experimental) and Leuprolide acetate - Formulation B (experimental).

The registry classes the interventions as drug.

More on the Plan

A total of 300 male subjects were planned to be enrolled.

Subjects were to receive a total of 2 intramuscular (IM) injections of the same formulation, either Formulation A or Formulation B, administered 24 weeks apart.

The first 150 subjects were to receive Formulation A for both injections and the next 150 subjects were to receive Formulation B for both injections.

All analyses and summaries were to be conducted separately for subjects who received Formulation A or Formulation B.

Who Took Part

310 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: Voluntarily sign an IRB-approved informed consent form and any required privacy statement/authorization form. Pre-trial serum testosterone level \>150 ng/dL. Histologically-confirmed prostatic adenocarcinoma in Jewett Clinical Stage A2, B, C or D and TNM\* classification cT1b-4, N: any, M: any. Prostate cancer and general clinical status is sufficient to warrant at least 48 weeks of continuous androgen deprivation treatment, without concomitant antiandrogen treatment. Eastern Cooperative Oncology Group (ECOG) Performance status grades 0,1,or 2 at the time of pre-trial screening.

The full record lists 8 inclusion and 18 exclusion criteria; among the exclusions: requires additional treatment including radical prostatectomy, radiotherapy or cryotherapy of local disease; historical, clinical, or radiographic evidence of central nervous system metastases, including spinal cord metastasis; clinical evidence of urinary tract obstruction.

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 2008-02 with completion listed for 2009-08.

It ran at 63 sites in United States (63).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Percentage of Subjects With Suppression of Serum Testosterone (<=50 ng/dL) From Week 4 to Week 48 for Formulation A: Intent-to-treat (ITT) Population for the Primary Endpoint (time frame: Week 4 to Week 48). Adjusted Percentage of Subjects With Suppression of Serum Testosterone (<=50 ng/dL) From Week 4 to Week 48 for Formulation A: ITT Population for the Primary Endpoint Adjusted (time frame: Week 4 to Week 48). Percentage of Subjects With Suppression of Serum Testosterone (<=50 ng/dL) From Week 4 to Week 48 for Formulation B: ITT Population for the Primary Endpoint Preplanned (time frame: Week 4 to Week 48).

It also tracked 8 secondary outcomes, for example Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation A: ITT Population, Mean Testosterone Concentration (+/- Standard Error) at Each Visit for Formulation B: ITT Population, Mean (+/- Standard Error) Acute-on-chronic Changes in Testosterone From Pre-injection Levels for Formulation A: ITT Population, Mean (+/- Standard Error) Acute-on-chronic Changes in Testosterone From Pre-injection Levels for Formulation B: ITT Population, Mean (+/- Standard Error) Acute-on-chronic Changes in Luteinizing Hormone From Pre-injection Levels for Formulation A: ITT Population and Mean (+/- Standard Error) Acute-on-chronic Changes in Luteinizing Hormone From Pre-injection Levels for Formulation B: ITT Population.

What This Means in Plain Language

Put simply, this is a phase 3, non-randomized trial of Leuprolide in 310 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.