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.
Project Responsibility: Professor, Consultant, DMSc Michael Borr
The MolBio-PSMA study
in the study, we establish a biobank, with the main objective to study biomarkers in circulating blood in a cohort with optimal staging with PSMA-PET/CT.
Among others, we study patients with newly diagnosed prostate cancer and primary staging with PSMA PET/CT and study the correlation between circulating tumor-DNA, mutation-profile and other biomarkers against whole-body tumor burden, disease stage, treatment outcome etc.
The aim is to develop new non-invasive biomarkers for diagnosis, prognosis and risk-evaluation of prostate cancer patients that can hopefully guide treatment choice for the individual patient.
The study is performed in close collaboration between Department of Nuclear Medicine and PET-Centre, Department of Urology and Department of Molecular Medicine (MOMA).
Primary responsibility: MD, PhD Mads Ryø Jochumsen, Department of Nuclear Medicine and PET-Centre, Aarhus University Hospital