Clinical trial · Interventional
Evaluation of an MRI-based Prostate Cancer Screening Program (VISIONING): 5-Year Follow-up Round (VISIONING III)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MRI | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- MRI-Guided screening
- interventionNames
- Diagnostic Test: MRI
Primary outcomes (1)
- measure
- Detection rate of clinically significant prostate cancer at 5-year follow-up
- timeFrame
- From enrollment to the last examination at 4-5 weeks
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available