A Study of Androgen Deprivation With Leuprolide, +/- Docetaxel for Clinically Asymptomatic Prostate Cancer Participants With a Rising Prostate Specific Antigen (PSA)

What Was Tested

This registered phase 3 trial tested Leuprolide.

The secondary objectives were: * To assess cancer specific survival; * To compare overall survival between the 2 treatment groups; * To evaluate patient-reported outcomes including quality of life, fatigue, and sexual functioning as measured by 3 different assessments.

It had two arms (groups): Docetaxel+Leuprolide+Bicalutamide (experimental) and Leuprolide+Bicalutamide (active comparator).

The registry classes the interventions as drug.

More on the Plan

The duration of the study per participant was to be at least 36 months, of which the treatment period was 18 months for all participants, followed by at least 18 months follow-up period.

Who Took Part

Enrollment: 413 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: Diagnosis of prostate adenocarcinoma pathologically confirmed. History of radical prostatectomy (pre-operative radiation therapy to the prostate or pelvis or salvage radiation after radical prostatectomy was allowed). Serum testosterone \>=100 nanogram per deciliter (ng/dL). Karnofsky performance status (KPS) \>=70 percent (%). Adequate organ function as defined by the following laboratory criteria:.

The full record lists 16 inclusion and 12 exclusion criteria; among the exclusions: uncontrolled serious active infection; anticipated duration of life \< 2 years; less than 5-year history of successful treatment for other cancers or concurrent active nonprostate cancer other than nonmelanoma dermatologic tumor.

How the Study Was Run

Design: randomized, parallel-group and open-label.

The participants were allocated by chance, so the Leuprolide group and the comparison group should start out alike.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Leuprolide study did not mask who received what.

It started in 2007-07 with completion listed for 2012-09.

It ran at 9 sites in United States (1), Belgium (1), Canada (1), Czechia (1), Germany (1) and Lithuania (1).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Median Progression-Free Survival (PFS) in Intent-to-treat (ITT) Population. Progression-Free Survival (PFS) Rate at Month 36 in ITT Population (time frame: Month 36). Median Progression-Free Survival (PFS) in Testosterone Specific Evaluable Population.

It also tracked 6 secondary outcomes, for example Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Total Score at End of Treatment (EOT), Change From Baseline in Functional Assessment of Cancer Therapy-Prostate (FACT-P) Trial Outcome Index (TOI) Score at EOT, Change From Baseline in Multidimensional Assessment of Fatigue (MAF) Index Score at EOT and Change From Baseline in Erectile Function Domain of International Index of Erectile Function (EF-IIEF) Total Score at EOT.

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Leuprolide in 413 people.

It ended early (terminated); results are posted on the registry, and this page does not restate them.

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