The BARCODE 1 Pilot Study

Study Overview
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Brief Summary
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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
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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.

Official Title
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The BARCODE 1 Pilot Study: The Use of Genetic Profiling to Guide Prostate Cancer Targeted Screening

Conditions
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Prostate Cancer

Intervention / Treatment
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* Genetic: Genetic SNP profiling
* Other: Prostate cancer screening
* Procedure: Prostate biopsy


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Stage 1<br>Caucasian men aged 55-69 to undergo genetic profiling. | Genetic: Genetic SNP profiling<br>* Genetic SNP profiling of known prostate cancer predisposition SNPs will be performed on DNA extracted from saliva samples.<br>|
| Stage 2<br>Men from Stage 1 identified as having a higher genetic risk score (top 10%) for prostate cancer. | Genetic: Genetic SNP profiling<br>* Genetic SNP profiling of known prostate cancer predisposition SNPs will be performed on DNA extracted from saliva samples.<br>Other: Prostate cancer screening<br>* 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.<br>Procedure: Prostate biopsy<br>* Prostate biopsy will be offered to men identified within the top 10% genetic risk score profile.<br>* Other names: TRUS Biopsy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association of SNP genetic risk score with prostate biopsy results. |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 |