Early and Accurate Detection of Prostate Cancer in General Practice

NCT ID: NCT03431753

Last Updated: 2021-05-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 3000 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-01
• Study Completion Date: 2021-12-31

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

PSA, STHLM3 and mpMRI for PC detection

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.

Group Type: EXPERIMENTAL

PSA, STHLM3 and mpMRI for PC detection

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Regional Hospital Holstebro

OTHER

Sponsor Role: collaborator

University of Aarhus

OTHER

Sponsor Role: collaborator

Central Denmark Region

OTHER

Sponsor Role: collaborator

Karolinska Institutet

OTHER

Sponsor Role: collaborator

Karolinska University Hospital

OTHER

Sponsor Role: collaborator

Aarhus University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bodil G. Pedersen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Department of Radiology, Aarhus University Hospital

Karina D. Sørensen, Professor

Role: PRINCIPAL_INVESTIGATOR

Dept. of Molecular Medicine (MOMA) at Aarhus University Hospital

Locations

General Practice

Aarhus, Central Jutland, Denmark

Countries

Denmark

Other Identifiers

PRIMA

Identifier Type: -

Identifier Source: org_study_id