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

NCT07762911 | Recruiting

• 1 other identifier: Visioning III
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Prostate Cancer

Keywords

Prostate; Prostate Cancer; Prostate cancer screening; Prostate carcinoma; Prostate-specific antigen (PSA); MRI-based screening

Outcome Measures

Primary Outcomes (1)

• 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.

  From enrollment to the last examination at 4-5 weeks

Study Arms (1)

MRI-Guided screening

OTHER

Diagnostic Test: MRI

Interventions

MRI DIAGNOSTIC_TEST

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.

MRI-Guided screening

Eligibility Criteria

• Age: 50 Years+
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• "well-informed men" with the wish for prostate cancer screening:
• prostate biopsy naïve
• life expectancy \> 10 years
• Paticipant in the VISIONING study

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

University Hospital Basel, Urology

Basel, Canton of Basel-City, 4031, Switzerland

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Central Study Contacts

Cyrill Rentsch, Prof.

CONTACT

+41 61 32 87122; cyrill.rentsch@usb.ch

Viktor Alargkof, MD

CONTACT

+4161328725; viktor.alargkof@usb.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2026
• First Posted: August 13, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: August 13, 2026

Record last verified: 2026-08

Locations

CH (1)