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

Condition: Prostate Cancer

Study Type: Observational

Clinical Trials Identifier NCT 8-digits: NCT03857477

Sponsor: Institute of Cancer Research, United Kingdom

Phase:

Eligibility:

• Age: minimum 55 Years maximum 69 Years
• Gender: Male

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.

View trial on ClinicalTrials.gov