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Research Article: Danish Prostate Cancer Consortium Study 1 (DPCC-1) protocol: Multicentre prospective validation of the urine-based three-microRNA biomarker model uCaP

Date Published: 2023-11-08

Abstract:
Introduction The primary objective of the Danish Prostate Cancer Consortium Study 1 (DPCC-1) is to provide validation for a novel urine-based microRNA biomarker, called uCaP, for a diagnosis of prostate cancer. Methods and analysis Eligible participants are biopsy naïve men aged ?18 years with prostate-specific antigen (PSA) levels ?3 ng/mL, who are referred to prostate MRI due to suspicion of PC at one of the following three major urology/uroradiology centers: Aarhus University Hospital, Herlev & Gentofte University Hospital, or Odense University Hospital, where MRI and targeted biopsy are implemented in clinical use. Exclusion criteria include previous diagnosis of urogenital cancer, contraindication to MRI, gender reassignment treatment or PSA level >20?ng/mL. The participants will be asked to donate a urine sample in connection with their MRI. The study is observational, uses a diagnostic accuracy testing setup and will integrate into the current diagnostic pathway. We will measure the levels of the three microRNAs in the uCaP model (miR-222–3?p, miR-24–3?p and miR-30c-5p) in extracellular vesicle-enriched cell-free urine samples, to assess if uCaP can improve specificity and retain sensitivity for International Society of Urological Pathology Grade Group ?2?PC, when used as a reflex test to PSA ?3?ng/mL. We hypothesise that uCaP can improve selection for prostate MRI and reduce the number of unnecessary scans and biopsies. Ethics and dissemination This study is approved by the Central Denmark Region Committee on Health Research Ethics (reference number: 1-10-72-85-22). All participants will provide written informed consent. Study results will be published in peer-reviewed journals and presented in scientific meetings. Trial registration number NCT05767307 at clinicaltrials.gov.

Introduction:
Prostate cancer (PC) accounts for approximately 20% of all cancers diagnosed among males in Denmark, with 4500 new cases each year, and numbers are expected to rise in the future due to the ageing population. 1 2 Historically, detection of PC has been based on symptoms, an elevated prostate-specific antigen (PSA) test and/or a suspect digital rectal examination (DRE) followed by a confirmation test by transrectal ultrasound guided biopsies. However, as of 2020, clinical guidelines in both Europe and USA recommend…

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