About this trial
Prostate cancer remains one of the leading causes of cancer-related morbidity and mortality among men. While PSA-based screening has been associated with reduced prostate cancer mortality, it also results in substantial overdiagnosis and overtreatment of clinically insignificant disease. Biparametric magnetic resonance imaging (bpMRI) has emerged as a promising imaging modality to improve the detection of clinically significant prostate cancer while reducing unnecessary biopsies.
In this prospective follow-up study, men who previously participated in prostate cancer screening and had no evidence of malignancy at baseline will be invited to undergo repeat screening approximately five years later. The study aims to evaluate the longitudinal performance of repeat screening using PSA and MRI, determine the incidence of newly detected clinically significant prostate cancer after an initial negative screening, and assess changes in imaging and clinical findings over time. The results will provide evidence on the value and optimal interval of repeat prostate cancer screening in men with an initially negative evaluation.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
prostate biopsy naïve
life expectancy > 10 years
Paticipant in the VISIONING study
Disqualifiers
prostate volume > 80ml
acute urinary tract infection UTI
NIH-CPSI score over or equal to19
IPSS score over or equal to 20 (leads to initiation of urologic diagnostics and treatment)
Trial design
Single group
Treatments tested in this trial
MRI
Diagnostic testParticipants undergo biparametric magnetic resonance imaging (bpMRI) of the prostate as part of the study diagnostic pathway. MRI findings guide the recommendation for targeted biopsy or standard biopsy according to the study protocol and predefined clinical criteria.
Treatment groups
Trial outcomes
Primary outcomes
Detection rate of clinically significant prostate cancer at 5-year follow-up
Number of participants with previously negative or non-significant findings who are diagnosed with clinically significant prostate cancer at 5-year follow-up after repeat biparametric MRI (bpMRI) and subsequent biopsy if indicated.
Sponsors and contacts
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