Early versus delayed endocrine treatment of pN1-3 M0 prostate cancer without local treatment of the primary tumor: results of European Organisation for the Research and Treatment of Cancer 30846--a phase III study.

What Was Tested

This randomized controlled trial looks at Androgen Antagonists.

The timing of endocrine treatment for prostate cancer remains controversial.

The issue is addressed in protocol 30846 of the European Organisation for Research and Treatment of Cancer for patients with lymph node positive cancer without local treatment of the primary tumor.

Who Took Part

The study group was 302 patients.

The age groups tagged for this paper are adults, middle-aged adults and older adults, men only.

A total of 302 patients with metastatic regional lymph nodes who had not received local treatment for the primary tumor were included in the trial, of whom 234 were randomized to immediate vs delayed endocrine treatment.

How the Study Was Run

In design terms this was a randomized study.

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

The main end point of the trial was overall survival.

Analysis followed the intent to treat principle.

What Was Measured

Topics PubMed links to this paper include Androgen Antagonists, Antineoplastic Agents, Hormonal, Cyproterone Acetate, Goserelin, Lymphatic Metastasis, Prostatic Neoplasms and Survival Rate.

What This Means in Plain Language

The paper is a randomized study of Androgen Antagonists in 302 patients.

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

Results are reported in around 5 sentences of the abstract; we leave them to the paper itself rather than summarise them.

The publication is from 2004 (The Journal of urology), a journal based in United States.

More context: all human trials.