Clinical trial NCT03431753: Early and Accurate Detection of Prostate Cancer in General Practice
Official title: Early and Accurate Detection of Prostate Cancer in General Practice Using Novel Molecular Biomarkers and Multiparametric MR Imaging.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Prostate Cancer
Prostate Neoplasm
Prostate Adenocarcinoma
Keywords: STHLM3-test
prostate cancer
MR-imaging
MR-targeted biopsy
MRI
Novel biomarkers
Genetic screening
Lead sponsor: University of Aarhus
Sponsor class: OTHER
Collaborators: name: Regional Hospital Holstebro
name: University of Aarhus
name: Central Denmark Region
name: Karolinska Institutet
name: Karolinska University Hospital
First posted: 2018-02-13
Enrollment: 3000
Sex: MALE
Minimum age (years): 50
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Proportion of PC suspicious lesions detected by mpMRI based on the STHLM3 test vs. the prostate specific antigen test.
timeFrame: 24 months
Secondary outcomes:
measure: Proportion of PC diagnoses detected in the study population based on the STHLM3 test vs. the prostate specific antigen test.
timeFrame: 24 months
measure: Compare results from clinical study with current clinical practice.
timeFrame: 24 months
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: General Practice
state: Central Denmark Region
Study officials:
affiliation: Department of Radiology, Aarhus University Hospital
name: Bodil G. Pedersen, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Dept. of Molecular Medicine (MOMA) at Aarhus University Hospital
name: Karina D. Sørensen, Professor
role: PRINCIPAL_INVESTIGATOR
References: