Intermittent Hormonal Therapy With Leuprorelin and Flutamide in the Treatment of Stage D2 or TxNxM1b,c

What Was Tested

The trial (phase 2) is built around Leuprolide.

The results will be compared with those obtained after continuous hormonal therapy with complete androgen suppression.

It had two arms (groups): Continuous Therapy (active comparator) and Intermittent therapy (experimental).

The registry classes the interventions as drug.

More on the Plan

It will involve 314 preselected patients.

A minimum of 180 eligible patients are required for this study.

Selected patients will be randomized centrally in two parallel groups at study entry.

This phase 2B study will enable evaluation of a high number of patients by direct comparison with conventional administration.

Who Took Part

341 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: Metastatic cancer of the prostate requiring first-line therapy. ECOG performance status of no more than 2. Normal testosterone levels according to the central laboratory standards. Aspartate transaminase (AST) and alanine transaminase (ALT) \< 2.25-fold higher than the standard levels set by the central laboratory (except when liver metastases were present). Anticipated life expectancy greater than 9 months.

The full record lists 9 inclusion and 7 exclusion criteria; among the exclusions: subject has received prior hormonal (and neoadjuvant) treatment prompting medical castration (estrogens, hormone-releasing hormone agonists, androgens) or has undergone surgical castration; subject has undergone bilateral suprarenalectomy or hypophysectomy; subject had another cancer (except basiloma) with the past 5 years.

How the Study Was Run

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

Because people in this Leuprolide study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Leuprolide group and the comparison group ran side by side rather than switching.

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

It started in 1996-12 with completion listed for 2005-09.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Median Overall Survival (time frame: Randomization (Month 6) up to Week 396 after randomization). Median Progression-Free Survival (time frame: Randomization (Month 6) up to Week 396 after randomization).

It also tracked 2 secondary outcomes, for example European Organization for research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ) - C30.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Leuprolide in 341 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.