Early and Accurate Detection of Prostate Cancer in General Practice
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|ClinicalTrials.gov Identifier: NCT03431753|
Recruitment Status : Enrolling by invitation
First Posted : February 13, 2018
Last Update Posted : November 5, 2020
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||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||3000 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Early and Accurate Detection of Prostate Cancer in General Practice Using Novel Molecular Biomarkers and Multiparametric MR Imaging.|
|Actual Study Start Date :||January 1, 2018|
|Estimated Primary Completion Date :||December 31, 2020|
|Estimated Study Completion Date :||December 31, 2022|
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.
- Proportion of PC suspicious lesions detected by mpMRI based on the STHLM3 test vs. the prostate specific antigen test. [ Time Frame: 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.
- Proportion of PC diagnoses detected in the study population based on the STHLM3 test vs. the prostate specific antigen test. [ Time Frame: 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. [ Time Frame: 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03431753
|Aarhus, Central Denmark Region, Denmark, 8200|
|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|