Early and Accurate Detection of Prostate Cancer in General Practice

Aarhus University Hospital

Status: Unknown

Conditions: Prostate Neoplasm; Prostate Adenocarcinoma; Prostate Cancer

Treatments: Diagnostic Test: PSA, STHLM3 and mpMRI for PC detection

Study type: Interventional

Funder types: Other

Identifiers

NCT03431753

PRIMA

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3,000 estimated patients

Sex: Male

Ages: 50 to 69 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• aged 50-69 years
• no previous pelvic cancer
• no previous prostate biopsy
• no previous elevated PSA results
• informed consent from the participant

Exclusion criteria

• palpable prostatae tumor by digital rectal examination
• previously diagnosed with/or treated for an urogenital cancer disease
• contraindications to 3 T MRI
• known severe renal impairment with estimated glomerular filtration rate <30 ml / min

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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3,000 participants in 1 patient group

PSA, STHLM3 and mpMRI for PC detection

Experimental group

Description:

mpMRI, and if suspect MR-targeted prostate biopsy, in men with increased PC risk as judged from the STHLM3 test and/or an elevated prostate specific antigen test.

Treatment:

Diagnostic Test: PSA, STHLM3 and mpMRI for PC detection