Abstract
TPS378 Background: Blood-based biomarkers and magnetic resonance imaging followed by targeted biopsies have been suggested to improve detection of prostate cancer by increasing sensitivity to detect significant disease, decrease over-detection of low-risk cancers and avoid benign biopsies. The STHLM3-MRI projects aims to assess the value of combining blood-based risk prediction with bi-parametric MRI (bpMRI) in the prostate cancer diagnostic chain. Methods: The STHLM3MRI Main Study is a randomized, diagnostic study recruiting ≈10,000 Swedish men aged 50-74 for prostate cancer testing in a screen-by-invitation setting. The study design includes a first paired step (blood-test) followed by a randomized step (biopsy technique). Participants with elevated blood-test levels (PSA≥3ng/ml or Stockholm3 test≥11% risk of GG≥2 cancer) are recommended further work-up and randomized 2:3 to 12-core systematic biopsies (standard arm) or to bpMRI followed by MRI-targeted biopsies and systematic biopsies in men with PI-RADSv2 ≥3 lesions (experimental arm). Endpoints include number of detected prostate cancers, number of performed biopsy procedures and number of performed MRIs. The study is centralized to three biopsy sites, one radiology department and one pathology department. A data safety and monitoring board monitors study progress and participant safety. There are two pre-planned main analyses. First, we will report the first large randomized evidence comparing MRI-targeted biopsies and systematic biopsies for prostate cancer detection in a screen-by-invitation setting. Second, we will report a comparison of a diagnostic strategy including the Stockholm3 blood-test and MRI-targeted biopsies with standard practice using PSA and systematic biopsies. A third analysis will compare the use of the bloodtests PSA and Stockholm3 for risk-stratification of men undergoing MRI-targeted biopsy. 9 Oct 2019 the study had included 47% of planned participants (n = 4,701), aiming to close inclusion by March 2020 with first report during 2020. The study is registered at ClinicalTrials.gov: NCT03377881 and has regional ethical approval (2017-1280/31). Clinical trial information: NCT03377881.
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