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The University of Southampton
Southampton Clinical Trials Unit

SABRE 1 Trial

Trial Name

SABRE 1 - Surgery And Brachytherapy: a Randomised Evaluation.

Description

A randomised feasibility study of brachytherapy and surgery in good risk prostate cancer.

Objectives

Primary Objective

Design

SABRE 1 is a multi-centre randomised controlled trial for men with localised prostate cancer. It has two separate randomisations. The first is a comparison of standard patient information versus standard information plus a decision aid (Decision Aid Randomisation). The second randomisation is between radical prostatectomy and brachytherapy (Treatment Randomisation) to determine feasibility of future trials. Stopping rules will be used to assess the effect of the decision aid on accrual into the treatment randomisation. If there is a significant positive effect demonstrated, all patients will be offered the decision aid for the treatment randomisation.

Status

Complete

Population

400 men with suspected clinically localised prostate cancer on the basis of an abnormal Digital Rectal Examination (DRE) or an elevated age-specific PSA and who are fit and suitable for either brachytherapy or radical prostatectomy.

Publication

SABRE 1 (Surgery Against Brachytherapy - a Randomised Evaluation): feasibility randomised controlled trial (RCT) of brachytherapy vs radical prostatectomy in low-intermediate risk clinically localised prostate cancer.

Contact details

All Trial enquiries should be addressed to ctu@soton.ac.uk

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