GENPROS aims to observe the outcomes in patients with rare germline genetic mutations including BRCA1, BRCA2, HOXB13 and MMR gene mutation carriers following prostate cancer (PrCa) diagnosis and treatment.
Men with prostate cancer and a germline genetic mutation in a gene predisposing to PrCa will be recruited to this study in order to observe outcomes.
The primary endpoint is to establish Cause Specific Survival (CSS) for men with PrCa and a germline mutation in a prostate cancer predisposition gene and to investigate whether they have a shorter Cause Specific Survival (CSS).
A sample of participants’ prostate tumour will be requested to investigate new biomarkers in this population using biochemistry, proteomic, metabolomic and microarray approaches. A sample of DNA will also be collected to look for associations of other genetic variants with PrCa outcome.
The study is currently open at 23 different hospitals within the UK and is aiming to open at a number of international sites later in 2017. GENPROS is aiming to recruit men 265 with a BRCA1 or BRCA2 mutation and 765 controls (who have tested negative for BRCA1/2 mutations) worldwide. Recruitment to the MMR cohort will commence in 2018.
- Men diagnosed with PrCa are eligible for the study if they are either:
- known carriers of germline mutations associated with PrCa risk
- known non-carriers of mutations in the genes above
- patients under 18 years of age
- patients who are unable to give informed consent
- patients who cannot be traced (<6 months’ follow-up) or whose clinical data are not available
- patients whose genetic status is unknown