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

• Decision aid randomisation: In men with localised prostate cancer, will the addition of a decision aid to standard information improve accrual to a randomised trial of radical prostatectomy versus brachytherapy?
• Treatment randomisation: Is it feasible to perform a phase III randomised controlled trial of brachytherapy versus radical prostatectomy in men with localised prostate cancer?

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