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 diagnosis of prostate cancer (PC).

Methods and analysis:

DPCC-1 is a prospective multicenter study performed in Denmark. Eligible participants are biopsy naïve men aged ≥ 18 years, 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 Hospital, or Odense University Hospital, where MRI and targeted biopsy are already implemented in clinical use. Exclusion criteria include previously diagnosed with urogenital cancers, contraindication for MRI, gender reassignment treatment, or prostate specific antigen (PSA) level > 20 ng/ml. The participants will be asked to donate urine samples at a urological center in connection with their MRI scan. The study is observational, uses a reflex testing setup, and will integrate into the current diagnostic pathway.

We will measure the levels of the three microRNAs in uCaP (miR-222–3p, miR-24–3p, and miR-30c-5p) in extracellular vesicle (EV)-enriched cell-free urine samples and assess if uCaP can improve specificity in detecting ISUP Gleason Grade Group ≥2 PC using uCaP score vs. PSA or a combination of uCaP+PSA vs. PSA alone. This could improve the specificity from PSA alone, while retaining the same sensitivity, for selection of men who need a prostate MRI, potentially reducing the number of unnecessary scans and biopsies.

Funding

The Novo Nordisk foundation has awarded a grant of 7.3 Million DKK to support the completion of the project through Investigator Initiated Clinical Trials. Out of the total grant amount, 6.3 million DKK will be allocated to AUH for both recruitment and uCaP analyses.