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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexMale
Age50+
SponsorUniversity Hospital, Basel, Switzerland

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

prostate biopsy naïve

life expectancy > 10 years

Paticipant in the VISIONING study

Disqualifiers

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)

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

300 Participants
are divided into 1 treatment group
Group A: MRI-Guided screeningOther 1 intervention

Trial outcomes

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.

Time frame
From enrollment to the last examination at 4-5 weeks

Secondary outcomes

Other outcomes

Sponsors and contacts

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