TY - JOUR
T1 - Danish Prostate Cancer Consortium Study 1 (DPCC-1) protocol
T2 - Multicentre prospective validation of the urine-based three-microRNA biomarker model uCaP
AU - Fredsøe, Jacob Hesselvig
AU - Glud, Eske Nøhr
AU - Boesen, Lars Ploug
AU - Løgager, Vibeke
AU - Poulsen, Mads Hvid
AU - Pedersen, Bodil Ginnerup
AU - Borre, Michael
AU - Sørensen, Karina Dalsgaard
PY - 2023/11
Y1 - 2023/11
N2 - 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.
AB - 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.
KW - Diagnostic radiology
KW - Magnetic resonance imaging
KW - ONCOLOGY
KW - Prostate disease
UR - http://www.scopus.com/inward/record.url?scp=85176413671&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2023-077020
DO - 10.1136/bmjopen-2023-077020
M3 - Journal article
C2 - 37940151
SN - 2044-6055
VL - 13
JO - BMJ Open
JF - BMJ Open
IS - 11
M1 - e077020
ER -