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The University of Southampton
Southampton Clinical Trials Unit

SAKK 08/11 Trial

Trial Name

SAKK 08/11 - Orteronel maintenance therapy in patients with metastatic castration resistant prostate cancer and non-progressive disease after first-line docetaxel therapy: A multicenter randomized double-blind placebo-controlled phase III trial.

Description

An international phase III randomised placebo controlled trial, using orteronel as maintenance therapy following first line treatment with docetaxel for men with metastatic prostate cancer. This trial is looking to recruit 192 patients in the UK and Switzerland & Germany.

Objectives

To determine the impact of maintenance orteronel on disease progression and quality of life.

Design

Multicenter, randomized, double-blind, placebo-controlled, phase III trial for patients with metastatic castration resistant prostate cancer who have achieved disease stabilisation after first line docetaxel chemotherapy. Eligible patients will be randomised to receive either 300 mg orteronel BID with Best supportive care (arm A) or placebo with Best supportive care (arm B).

Status

Complete

Population

192 men with metastatic castration resistant prostate cancer who have achieved disease stabilisation after first line docetaxel chemotherapy.

Publication

Orteronel switch maintenance therapy in metastatic castration resistant prostate cancer after first-line docetaxel: a multicenter, randomized, double-blind, placebo-controlled trial (SAKK 08/11)

Contact details

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

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