The BARCODE 2 Study - The Use of Genetic Profiling to Guide Prostate Cancer Treatment

Summary

Prostate cancer (PrCa) is one of the commonest cancer in men in the Western world. In the United Kingdom (UK), there were over 52,000 new cases diagnosed in 2016-2018 and a lifetime risk of 1 in 8. Research studies have identified several genetic changes that are thought to increase the risk of developing prostate cancer. Some of these genetic changes occur in deoxyribonucleic acid (DNA) repair genes. The BARCODE 2 trial is formed of two parts that aim to investigate how having genetic changes in DNA repair genes can affect response to carboplatin treatment in patients with metastatic castration resistant prostate cancer (mCRPC). In part 1 of the study, the investigators will invite men with mCRPC who have not had genetic testing before to join the study by initially undergoing genetic screening within the study. The DNA repair gene mutation carrier status of enrolled patients will be assessed using a gene panel. If a pathogenic mutation is confirmed in one of these genes, patients will be given the option to proceed to part 2 of the study. In part 2 of the study, men with mCRPC who are known to be carriers of a mutation in DNA repair gene(s) will be assessed for eligibility for treatment on the study with carboplatin chemotherapy. The aim of the study will be to determine how patients with mCRPC and a germline mutation in a DNA repair gene(s) respond to platinum chemotherapy. This study will help researchers to investigate platinum sensitivity of prostate tumours that have developed due to a germline mutation in a DNA repair gene. This study will provide data to use in a larger clinical trial of platinum chemotherapy based on patients' germline genetic signature and/or tumour genetic profile.

Conditions

• Hormone Refractory Prostate Cancer

Interventions

DRUG

Carboplatin

Intravenous carboplatin infusion every 3 weeks.

Sponsors & Collaborators

• Royal Marsden NHS Foundation Trust

  collaborator OTHER

• European Research Council

  collaborator OTHER

• Imperial College Healthcare NHS Trust

  collaborator OTHER

• Dartford and Gravesham NHS Foundation Trust

  collaborator UNKNOWN

• Maidstone & Tunbridge Wells NHS Trust

  collaborator OTHER

• East and North Hertfordshire NHS Trust

  collaborator OTHER_GOV

• Royal Free Hampstead NHS Trust

  collaborator OTHER

• Buckinghamshire Healthcare NHS Trust

  collaborator OTHER

• Barts & The London NHS Trust

  collaborator OTHER

• Nottingham University Hospitals NHS Trust

  collaborator OTHER

• Yeovil District Hospital NHS Foundation Trust

  collaborator OTHER

• Northampton General Hospital NHS Trust

  collaborator OTHER

• Institute of Cancer Research, United Kingdom

  lead OTHER

Principal Investigators

• Rosalind A Eeles, FRCP, FRFR · Institute of Cancer Research and Royal Marsden Hospital

Study Design

Allocation

NA

Purpose

TREATMENT

Masking

NONE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2017-05-25

Primary Completion

2026-12-31

Completion

2028-12-31

Countries

• United Kingdom

Study Locations