BARCODE 1: The Use of Genetic Profiling to Guide Prostate Cancer Targeted Screening
Update for participants:
All research activities for this study were temporarily suspended during the peak of the COVID-19 pandemic in 2020. The study resumed in July 2020, however, due to the high level of interest we received about joining this study and the disruption from the pandemic (our nurses and doctors were busy helping out in other clinical areas) we have had some delays in feeding back the genetic profiling results to men who have sent samples to us. All efforts are being made to contact study participants as soon as possible and we will be notifying all men in writing about the outcome of their genetic profiling results. Please get in touch with the study team if you have any questions via either firstname.lastname@example.org or calling 0208 722 4483.
The BARCODE 1 study 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.
Men will be 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 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.
• 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.
• 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.
• 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, Apixaban, Dabigatran or other NOAC medications (Novel Oral Anti-Coagulant); poorly controlled diabetes or cardiovascular/respiratory disease, immunosuppressive medication or splenectomy).
• Men with body mass index (BMI) 40 and above.
• Men with BMI 35 and above plus 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.