Evaluation of an MRI-based Prostate Cancer Screening Program (VISIONING): 5-Year Follow-up Round (VISIONING III)

Condition(s) studied

Investigational drug(s) / intervention(s)

MRI: Participants 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.

Study summary

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

Primary outcome measure(s)

• Detection rate of clinically significant prostate cancer at 5-year follow-up — From enrollment to the last examination at 4-5 weeks
  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.

Trial sites (1)

More University Hospital, Basel, Switzerland trials in Switzerland

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