The use of flutamide in hormone-refractory metastatic prostate cancer.

What Was Tested

The paper reports a study of Leuprolide and Flutamide, published as a randomized controlled trial.

In a recent intergroup study under the auspices of the National Cancer Institute, 603 eligible patients with newly diagnosed disseminated adenocarcinoma of the prostate were prospectively randomized in a double-blinded clinical trial to receive either a gonadotropin-releasing hormone analogue (leuprolide) and a nonsteroidal antiandrogen (flutamide) or leuprolide and placebo.

Of the 603 eligible patients, 300 were in the leuprolide and placebo arm and 303 were in the leuprolide and flutamide arm.

Who Took Part

According to the abstract, 603 patients were involved.

PubMed tags the participants as men only.

At the time of disease progression, the code was broken: Those patients in the placebo arm were given the opportunity to receive flutamide, and the patients in the flutamide arm were treated at their physician's discretion.

How the Study Was Run

In design terms this was a randomized, double-blind and placebo-controlled study.

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.

Blinding on both sides kept the patients and researchers unaware of who received Leuprolide.

Some patients received a placebo instead of Leuprolide, giving a reference point.

What Was Measured

PubMed files the paper under topics including Adenocarcinoma, Antineoplastic Combined Chemotherapy Protocols, Flutamide, Leuprolide, Neoplasm Metastasis, Prostatic Neoplasms and Regression Analysis.

What This Means in Plain Language

The paper is a randomized, double-blind and placebo-controlled study of Leuprolide and Flutamide in 603 patients.

With several hundred people or more, it is a fairly large study for this kind of research.

The publication is from 1993 (Cancer), a journal based in United States.

More context: the related Leuprolide library page, all human trials.