Evaluation of an MRI-based Prostate Cancer Screening Program (VISIONING): 5-Year Follow-up Round (VISIONING III)
Recruiting · NCT07762911 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital, Basel, Switzerland
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Inclusion criteria
- "well-informed men" with the wish for prostate cancer screening:
- prostate biopsy naïve
- life expectancy \> 10 years
- Paticipant in the VISIONING study
Exclusion criteria
- 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)
- life expectancy \< 10 years
Where it is running
1 location listed.
- University Hospital Basel, Urology - Basel, Canton of Basel-City, Switzerland