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

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.

NCT Number	NCT02955082
Lead Sponsor	Institute of Cancer Research, United Kingdom Collaborators: Royal Marsden NHS Foundation Trust, European Research Council, Imperial College Healthcare NHS Trust, Dartford and Gravesham NHS Foundation Trust, Maidstone & Tunbridge Wells NHS Trust, East and North Hertfordshire NHS Trust, Royal Free Hampstead NHS Trust, Buckinghamshire Healthcare NHS Trust, Barts & The London NHS Trust, Nottingham University Hospitals NHS Trust, Yeovil District Hospital NHS Foundation Trust, Northampton General Hospital NHS Trust
Conditions	Hormone Refractory Prostate Cancer
Enrollment	305 participants
Start Date	2017-05-25
Primary Completion	2026-12-31 (estimated)
Study Completion	2028-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-02-04