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.

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.

Study Overview

• Status: Unknown
• Conditions: Prostate Cancer; Prostate Adenocarcinoma; Prostate Neoplasm
• Intervention / Treatment: Diagnostic test: PSA, STHLM3 and mpMRI for PC detection

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 Type: Interventional
• Enrollment (Anticipated): 3000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Central Denmark Region
    • Aarhus, Central Denmark Region, Denmark, 8200
      • General Practice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 69 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of PC suspicious lesions detected by mpMRI based on the STHLM3 test vs. the prostate specific antigen test.	Evaluation of the proportion of patients identified with PC suspicious lesions at mpMRI based on the STHLM3 vs. the prostate specific antigen test.	24 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of PC diagnoses detected in the study population based on the STHLM3 test vs. the prostate specific antigen test.	Evaluation of the proportion of total PCs and clinically significant PCs diagnosed with MR guided biopsy as a function of the primary tests.	24 months
Compare results from clinical study with current clinical practice.	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.	24 months

Collaborators and Investigators

• Sponsor: Aarhus University Hospital
• Collaborators: Karolinska University Hospital; Karolinska Institutet; University of Aarhus; Central Denmark Region; Regional Hospital Holstebro
• 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

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 1, 2018
• Primary Completion (ANTICIPATED): December 31, 2021
• Study Completion (ANTICIPATED): December 31, 2021

Study Registration Dates

• First Submitted: December 21, 2017
• First Submitted That Met QC Criteria: February 12, 2018
• First Posted (ACTUAL): February 13, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 4, 2021
• Last Update Submitted That Met QC Criteria: May 3, 2021
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: MRI; prostate cancer; STHLM3-test; MR-imaging; MR-targeted biopsy; Novel biomarkers; Genetic screening
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: PRIMA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No