Early and Accurate Detection of Prostate Cancer in General Practice

Sponsor

Aarhus University Hospital (Other)

Overall Status

Enrolling by invitation

CT.gov ID

NCT03431753

Collaborator

Regional Hospital Holstebro (Other), University of Aarhus (Other), Central Denmark Region (Other), Karolinska Institutet (Other), Karolinska University Hospital (Other)

3,000

Enrollment

Location

Arm

Anticipated Duration (Months)

62.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer Prostate Neoplasm Prostate Adenocarcinoma	Diagnostic Test: PSA, STHLM3 and mpMRI for PC detection	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

3000 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

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

Actual Study Start Date :

Jan 1, 2018

Anticipated Primary Completion Date :

Dec 31, 2021

Anticipated Study Completion Date :

Dec 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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.

Arm

Intervention/Treatment

Experimental: 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.

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.

Outcome Measures

Primary Outcome Measures

Proportion of PC suspicious lesions detected by mpMRI based on the STHLM3 test vs. the prostate specific antigen test. [24 months]
Evaluation of the proportion of patients identified with PC suspicious lesions at mpMRI based on the STHLM3 vs. the prostate specific antigen test.

Secondary Outcome Measures

Proportion of PC diagnoses detected in the study population based on the STHLM3 test vs. the prostate specific antigen test. [24 months]
Evaluation of the proportion of total PCs and clinically significant PCs diagnosed with MR guided biopsy as a function of the primary tests.
Compare results from clinical study with current clinical practice. [24 months]
Comparison of the results from the clinical study with the number of prostate specific antigen tests, TRUS-biopsies, indolent and significant PCs detected by current clinical practice, using health register data from general practices not taking part in the trial.

Eligibility Criteria

Criteria

Ages Eligible for Study:

50 Years to 69 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	General Practice	Aarhus	Central Denmark Region	Denmark	8200

Sponsors and Collaborators

Aarhus University Hospital
Regional Hospital Holstebro
University of Aarhus
Central Denmark Region
Karolinska Institutet
Karolinska University Hospital

Investigators

Principal Investigator: Bodil G. Pedersen, MD, PhD, Department of Radiology, Aarhus University Hospital
Principal Investigator: Karina D. Sørensen, Professor, Dept. of Molecular Medicine (MOMA) at Aarhus University Hospital