BARCODE 2
Research type
Research Study
Full title
Targeting cancer care with the use of genetic profiling
IRAS ID
202638
Contact name
Rosalind Eeles
Contact email
Sponsor organisation
The Institute of Cancer Research
Eudract number
2016-000869-23
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
The BARCODE 2 study is a two staged open-label, single centre, and single treatment phase II study. The study will invite participants with metastatic castration resistant prostate cancer (mCRPC) who have progressed after treatment with docetaxel chemotherapy and enzalutamide or abiraterone to initially investigate whether they have a mutation in a gene that will likely have contributed to the development of their cancer. Knowledge of the inherited genetic status of DNA repair genes will be used to alter the treatment pathway for mCRPC patients. It is known that a mutation (error) in certain genes can cause or contribute to the development of cancer. Some of these genes are called ‘DNA repair genes’ as they help correct errors when DNA replicates itself. Errors in these genes then also lead to a higher risk of developing certain types of cancer, including breast, ovarian and prostate cancer. There is evidence that carriers of these mutations with other types of cancer, such as breast and ovarian cancer are more responsive to chemotherapy treatments that contain platinum, and emerging evidence suggests that this may also be the case for men with prostate cancer.
Participants will be identified for enrolment to the study by either being a known carrier of a mutation in a DNA repair gene having had a clinical genetic test prior to enrolment or by undergoing genetic testing (screening) within the study. The participants consent will be sought for this initial (genetic mutation confirmation) stage. Those with a mutation found will be asked to consent to the treatment stage of the study and offered carboplatin chemotherapy and will be assessed with imaging and prostate specific antigen (PSA) levels for response to treatment.
Participants will be followed until death to measure survival outcomes. This is a hypothesis generating study, to test the platinum sensitivity of prostate tumours that have developed due to a 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.
REC name
London - Chelsea Research Ethics Committee
REC reference
16/LO/1686
Date of REC Opinion
22 Nov 2016
REC opinion
Further Information Favourable Opinion