GENPROS aims to observe the treatment outcomes in patients with rare germline genetic mutations in prostate cancer predisposition genes 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 open worldwide with sites currently open at 23 different hospitals within the UK and four international sites in US, Israel, Lithuania and Norway, with other international sites in set up. GENPROS is aiming to recruit individuals with a pathogenic variant in a gene thought to predispose to prostate cancer (e.g. BRCA1, BRCA2, HOXB13, ATM, MSH6, MSH2, MLH1, PMS2 and other listed genes) and controls recruited from individuals who have tested negative for pathogenic variants in the listed genes.
Eligibility
Inclusion criteria:
- 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
Exclusion criteria:
- 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