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BARCODE 1: The Use of Genetic Profiling to Guide Prostate Cancer Targeted Screening

The BARCODE 1 study has been developed to investigate the role of genetic profiling for targeting population screening. This study forms a pilot of 300 men, with the view to continue to a future study of 5000 men.

The primary aim of this study is to determine the association of biopsy result with genetic risk score in men having targeted prostate screening based on single nucleotide polymorphism (SNP) risk profiling. 

Men will be recruited from GP practices, a genetic profile of their prostate cancer risk preformed and prostate biopsy offered to those in top 10% of the risk profile. The secondary aim of this study is to determine the incidence and aggressiveness of prostate cancer (PrCa) in men within the top 10% of the genetic score.

Additional blood, urine, saliva and tissue samples will be taken for research purposes in order to investigate new biomarkers in this population using biochemistry, proteomic, metabolomic and microarray approaches.

Samples will be collected from urine for further studies to correlate these with SNP profile, but biopsy decisions will not be made on these results. The tertiary aim of this study is to determine the association of biological sample biomarker profile with prostate biopsy result in men at genetically higher PrCa risk undergoing targeted PrCa screening.

Inclusion criteria:

  • Men aged 55-69 years
  • Caucasian ethnicity
  • World Health Organisation (WHO) performance status 0-2 as assessed and documented by study doctor
  • Absence of any psychological, familial, sociological or geographical situation potentially hampering compliance with the study protocol and follow-up schedule

Exclusion criteria

  • Non-Caucasian ethnicity (including Mixed race or Jewish)
  • Previous diagnosis of cancer with a life-expectancy of less than five years
  • Prostate biopsy in the past year
  • Previous diagnosis of prostate cancer
  • Co-morbidities making prostate biopsy risk unacceptable (anticoagulants or antiplatelet medication like Warfarin or Clopidogrel, poorly controlled diabetes or cardiovascular disease)