The BARCODE 1 Study (Full Study): The Use of Genetic Profiling to Guide Prostate Cancer Targeted Screening.

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. A pilot of 300 men were recruited aiming to inform the feasibility and accessibility of the study approach. The full study is an extension of the pilot study aiming to recruit a total 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 were recruited via participating General Practices (GPs). The full study aims to recruit an additional 4700 participants. 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 sign a consent form and complete a questionnaire to confirm eligibility to participate. 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 470 men in total from the full study) will be invited for an MRI and a transperineal (TP) prostate biopsy under local anaesthetic (LA), plus further biological samples. Biopsy results will be correlated with the genetic score. The study also aims to determine the incidence and aggressiveness of prostate cancer in men within the top 10% of the genetic score. Furthermore, the association of MRI appearance and biological sample biomarker profile with prostate biopsy result in men at genetically higher prostate cancer risk undergoing targeted screening will also be determined.

Official Title
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The BARCODE 1 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: MRI Scan
* Procedure: Prostate biopsy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men aged 55 to 69 years. Caucasian ethnicity. 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 Ashkenazi Jewish (excluded as these groups have different genetic risk profiles from those being studied). Previous diagnosis of cancer with a life-expectancy of less than five years. Negative prostate biopsy within one year before recruitment. Previous diagnosis of prostate cancer. Co-morbidities making prostate biopsy risk unacceptable (anticoagulants or antiplatelet medication including Warfarin, Clopidogrel, Apixaban, Dabigatran or other NOAC medications (Novel Oral Anti-Coagulant); poorly controlled diabetes, cardiovascular/respiratory disease, immunosuppressive medication or splenectomy). Men with body mass index (BMI) 40 and above. Men with BMI 35 and above plus other co-morbidities. Contraindications to having an MRI (pacemakers, aneurysm clips, metallic cardiac valve/stent, Ventriculo-Peritoneal (VP) shunt, cochlear implant, neurotransmitter, metallic foreign bodies in eye(s), other metalwork, claustrophobia). Any significant psychological conditions that may be worsened or exacerbated by participation in the study.

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 SNP 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 will be offered an MRI scan, prostate biopsy and prostate cancer screening. | 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: MRI Scan<br>* MRI scan will be offered to men identified within the top 10% genetic risk score profile.<br>* Other names: MRI;Procedure: Prostate biopsy<br>* Transperineal prostate biopsy under local anaesthetic will be offered to men identified within the top 10% genetic risk score profile.<br>* Other names: Transperineal Biopsy (TP 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 population screening clinical environment. |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate Cancer