NCT03431753

Early and Accurate Detection of Prostate Cancer in General Practice

Early and Accurate Detection of Prostate Cancer in General Practice Using Novel Molecular Biomarkers and Multiparametric MR Imaging.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 3,000 (estimated)
• Sponsor: Aarhus University Hospital · Academic / Other
• Sex: Male
• Age: 50 Years – 69 Years
• Healthy volunteers: Accepted

Summary

Prostate cancer (PC) is the most common malignancy (4500 new cases/year) and the second leading cause of cancer-associated mortality (1200 deaths/year) among men in Denmark. PC is generally diagnosed on the basis of an elevated prostate specific antigen blood test followed by transrectal ultrasound (TRUS)-guided prostate biopsy. This study aims to test early detection of PC in general practice, using the STHLM3 model with superior specificity and sensitivity for clinically significant PC, combined with multiparametric magnetic resonance imaging (mpMRI) of the prostate and MR guided biopsy.

Detailed description

While early stage PC can be cured by surgery or radiation therapy, advanced PC is incurable and associated with high morbidity and mortality. Early detection is critical to save lives, but many newly diagnosed PCs are in reality non-aggressive and will not affect the patient's life or health, even if left untreated. There is an urgent need to replace current clinical practice with a more accurate diagnostic approach that can ensure early detection of aggressive PC while curable, reduce unnecessary prostate biopsies incl. risk of sepsis and reduce overdiagnosis/-treatment of indolent PC. New molecular biomarkers applied in general practice, serving as a pre-selection test for follow-up, and accurate and patient-friendly MR-imaging and MR-targeted biopsy at the hospital may help to solve these problems. In this study the investigators will assess the clinical utility of combining genetic risk testing and plasma protein markers (STHLM3 test) in general practice with mpMRI and MR-guided in bore biopsy (MRGB) for early PC detection in a biopsy naïve population.

Conditions

• Prostate Cancer
• Prostate Neoplasm
• Prostate Adenocarcinoma

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	PSA, STHLM3 and mpMRI for PC detection	Men who request a prostate specific antigen test from their general practitioner will be offered study participation. Men with increased PC risk as judged from the STHLM3 test and/or an elevated PSA test will be offered an mpMRI examination.

Timeline

• Start date: 2018-01-01
• Primary completion: 2021-12-31
• Completion: 2021-12-31
• First posted: 2018-02-13
• Last updated: 2021-05-04

Locations

1 site across 1 country: Denmark