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The University of Southampton
Southampton Clinical Trials Unit

ProCAID

Title

An open label phase I/randomised, double blind phase II study in metastatic castration resistant Prostate Cancer of AZD5363 In combination with Docetaxel and prednisolone chemotherapy

Description

A phase I/II trial to determine if the addition of the AKT inhibitor AZD5363 to docetaxel and prednisolone (DP) prolongs progression free survival (PFS) in metastatic castration resistant prostate cancer (mCRPC) to a degree worthy of further investigation.

Objectives

Primary Endpoints:

Phase I:

Phase II:

Secondary Endpoints:

Phase I:

Phase II:

Trial Design

ProCAID will first comprise a dose-finding, single arm, open label phase I study exploring the combination of AZD5363 and Docetaxel and prednisolone chemotherapy (DP). This will be followed by a double-blind, randomised phase II study comparing DP + AZD5363 with DP + placebo. All patients will have chemotherapy naive mCRPC and will be suitable for treatment with palliative docetaxel. Patients may, but are not required to, have had prior second generation anti-hormonal therapies (e.g., abiraterone, enzalutamide).

Phase I:


Phase II:

Trial Status

Closed to recruitment - In Follow up

Population

Metastatic castration resistant prostate cancer (mCRPC) patients suitable to receive palliative docetaxel chemotherapy

Phase I: 3-18 patients

Phase II: 132 (66 per arm)

Contact Details

All trial enquiries should be sent to [email protected]

Publications

Overall Survival Update for Patients with Metastatic Castration-resistant Prostate Cancer Treated with Capivasertib and Docetaxel in the Phase 2 ProCAID Clinical Trial - Simon Crabb, Gareth Griffiths, Denise Dunkley, Nichola Downs, et al.

Other Media

Results publicaton on SCTU website

Results publication in Southern Daily Echo

Funder

CRUK logo

This trial was funded by Cancer Research UK (award reference no. C9317/A16029) with additional financial support from AstraZeneca UK Ltd.

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