Prostate Cancer
Conditions
Brief summary
BARCODE 1 is a screening study designed to investigate the role of genetic profiling for targeting population prostate cancer screening. This study forms a pilot of 300 men, with the view to continue to a future study of 5000 men.
Detailed description
The BARCODE 1 study aims to evaluate genetic profiling using the known 170 prostate cancer (PrCa) risk single-nucleotide polymorphisms (SNPs) as a means of offering targeted screening for PrCa in men at a genetically higher risk. Initially, 300 men will be recruited via participating General Practices (GPs). Men aged 55-69 years who are likely to be eligible for the study will be identified by GPs from medical records. Participants will be contacted via invitation letters from GPs and if interested in the study will be asked to fill in a questionnaire to confirm eligibility to participate. This questionnaire can be completed in hard copy and men will also be given the option to fill in an online version. If eligible, men will then be sent a DNA collection saliva kit. DNA from saliva will be analysed with SNP profiling for the known 170 clinically relevant SNPs. Men with a genetic risk equivalent to the top 10% of the population distribution (approximately 30 men in total) will be invited for a transrectal ultrasound (TRUS) prostate biopsy, plus further biological samples. Biopsy results will be correlated with the genetic score. Prostate-specific antigen (PSA) and other biomarkers will be integrated into results to assess combined effects of genetic score and markers.
Interventions
GENETICGenetic SNP profiling
Genetic SNP profiling of known prostate cancer predisposition SNPs will be performed on DNA extracted from saliva samples.
OTHERProstate cancer screening
Prostate cancer screening in the form of PSA testing will be offered to all men who have a benign biopsy result for five years in order to track development of cancer in the future.
PROCEDUREProstate biopsy
Prostate biopsy will be offered to men identified within the top 10% genetic risk score profile.
Sponsors
Institute of Cancer Research, United Kingdom
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
55 Years to 69 Years
Healthy volunteers
Yes
Inclusion criteria
* Men aged 55-69 years * Caucasian ethnicity * World Health Organisation (WHO) performance status 0-2 * 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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Association of SNP genetic risk score with prostate biopsy results. | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Incidence and aggressiveness of PrCa in men within the top 10% of the genetic score. | 5 years |
| Association of the biomarker profile with genetic score and biopsy results. | 5 years |
| Use of genetic profiling to target prostate cancer screening in a clinical environment. | 5 years |
Countries
United Kingdom
Outcome results
None listed