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

NCT07762911 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2026-08-13

No results posted yet for this 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.

Conditions

Interventions

DIAGNOSTIC_TEST

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.

Sponsors & Collaborators

  • University Hospital, Basel, Switzerland

    lead OTHER

Study Design

Allocation
NA
Purpose
SCREENING
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
50 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-06-01
Primary Completion
2028-06-01
Completion
2028-06-01

Countries

  • Switzerland

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07762911 on ClinicalTrials.gov