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

Autor:	Fredsøe J; Department of Molecular Medicine, Aarhus University Hospital, Aarhus, Denmark.; Department of Clinical Medicine, Aarhus University, Aarhus, Denmark., Glud E; Department of Molecular Medicine, Aarhus University Hospital, Aarhus, Denmark.; Department of Clinical Medicine, Aarhus University, Aarhus, Denmark., Boesen L; Department of Urological Research, Herlev & Gentofte University Hospital, Herlev, Denmark., Løgager V; Department of Radiology, Herlev & Gentofte University Hospital, Herlev, Denmark., Poulsen MH; Department of Urology, Odense University Hospital, Odense, Denmark.; Department of Clinical Research, University of Southern Denmark, Odense, Denmark., Pedersen BG; Department of Radiology, Aarhus University Hospital, Aarhus N, Denmark., Borre M; Department of Molecular Medicine, Aarhus University Hospital, Aarhus, Denmark.; Department of Urology, Aarhus University Hospital, Aarhus, Denmark., Sørensen KD; Department of Molecular Medicine, Aarhus University Hospital, Aarhus, Denmark kdso@clin.au.dk.; Department of Clinical Medicine, Aarhus University, Aarhus, Denmark.
Jazyk:	angličtina
Zdroj:	BMJ open [BMJ Open] 2023 Nov 08; Vol. 13 (11), pp. e077020. Date of Electronic Publication: 2023 Nov 08.
DOI:	10.1136/bmjopen-2023-077020
Abstrakt:	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. Competing Interests: Competing interests: JF and KDS are co-inventors on an issued patent (“A microRNA-based method for early detection of prostate cancer in urine samples” #US10400288B2, #EP3256602B1, #ES2749651T3) licensed to Qiagen. KDS is co-inventor on an issued patent (“Biomarkers for prostate cancer” #US10106854B2, #AU2013275761B2, #JP6242388B2) licensed to Qiagen and on an issued patent (“A microRNA-based method for assessing the prognosis of a prostate cancer patient” #US10358681B2, #EP3262186B1, #ES2724404T3, #JP6769979B2), licensed to Qiagen. (© Author(s) (or their employer(s)) 2023. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.)
Databáze:	MEDLINE
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