Prostate Adenocarcinoma, Prostate Cancer, Prostate Neoplasm
Conditions
Keywords
STHLM3-test, prostate cancer, MR-imaging, MR-targeted biopsy, MRI, Novel biomarkers, Genetic screening
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.
Interventions
DIAGNOSTIC_TESTPSA, 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.
Sponsors
Regional Hospital Holstebro
University of Aarhus
Central Denmark Region
Karolinska Institutet
Karolinska University Hospital
Aarhus University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
50 Years to 69 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Denmark
Outcome results
None listed