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

  • STATUS
    Recruiting
  • End date
    Sep 1, 2027
  • participants needed
    4700
  • sponsor
    Institute of Cancer Research, United Kingdom
Updated on 11 March 2021
biopsy of prostate
prostate cancer screening

Summary

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.

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 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.

Details
Condition Malignant neoplasm of prostate, Prostatic disorder, Prostate Disorders, Prostate Cancer, Early, Recurrent, Prostate Cancer, prostate carcinoma, prostate cancers
Treatment Prostate Biopsy, MRI scan, Genetic SNP profiling, Prostate cancer screening
Clinical Study IdentifierNCT03857477
SponsorInstitute of Cancer Research, United Kingdom
Last Modified on11 March 2021

Eligibility

Yes No Not Sure

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
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