Quality of life in men with locally advanced prostate cancer treated with leuprorelin and radiotherapy with or without zoledronic acid (TROG 03.04 RADAR): secondary endpoints from a randomised phase 3 factorial trial

What Was Tested

Researchers studied Leuprolide in this randomized controlled trial publication.

In this study, the researchers investigated whether these treatments had a detrimental effect on patient-reported-outcome (PRO) scores.

Who Took Part

PubMed indexes the participants as middle-aged adults and older adults, men only.

Study drug administration commenced at randomisation after which radiotherapy started within the fifth month in all groups.

Treatment allocation was open-label, and computer-generated randomisation, stratified by centre, baseline concentrations of PSA, clinical stage of the tumour, Gleason score, and use of a brachytherapy boost, was done by use of the minimisation technique.

How the Study Was Run

The researchers set it up as a randomized and open-label 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.

Everyone knew when Leuprolide was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.

The trial is ongoing and the primary endpoint, prostate-cancer-specific mortality, will be reported in 2014.

This study is the final report of PRO scores (a secondary endpoint).

Analysis was by intention to treat.

This trial is registered with ClinicalTrials.gov, number NCT00193856.

What Was Measured

In this study, the researchers investigated whether these treatments had a detrimental effect on patient-reported-outcome (PRO) scores.

Topics PubMed links to this paper include Adenocarcinoma, Androgen Antagonists, Antineoplastic Agents, Hormonal, Bone Density Conservation Agents, Brachytherapy, Diphosphonates and Imidazoles.

What This Means in Plain Language

The paper is a randomized and open-label study of Leuprolide.

Its findings take up roughly 9 sentences of the abstract and are left out here on purpose; the source paper is the place to read them.

The publication is from 2012 (The Lancet. Oncology), a journal based in England.

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