ClinicalTrials.gg
RecruitingNCT07762911Visioning IIIUpdated Aug 13, 2026

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

An interventional study of MRI in Prostate Cancer, sponsored by University Hospital, Basel, Switzerland. Recruiting at 1 site in Switzerland. Open to male participants aged 50 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-08-13.

Sponsored by University Hospital, Basel, Switzerland · Not applicable, Interventional, and Screening

From the registry’s dates

  • Started Jun 2026; still recruiting 5 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Not applicable
Ages
50 Years and older
Sex
Male
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 136 studies in Prostatic Neoplasms with a site in Switzerland — 40 open to participants now, 58 under way, 20 of them phase 3. Prostatic Neoplasms · Switzerland.

Planned enrollment
39th of 107
300 · median 140
Started
2026
with 12 others
No phase
23 of 136
8 open now
Primary completion
2028-06
later than 31 of 57 live
Registered
131st of 136
by date
Lead sponsor
7 of 136
University Hospital, Basel, Switzerland

Among the 136 studies in Prostatic Neoplasms with a site in Switzerland, this one is the 39th largest by planned enrollment of the 107 interventional ones that give a count, is one of 13 that started in 2026, is one of 23 with no phase, reaches primary completion later than 31 of the 57 other live ones, and was the 131st registered.

Prostatic Neoplasms

7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,579 are open to participants now.

Browse Prostatic Neoplasms studies →

Open to participants now

40 of the 136 studies in Prostatic Neoplasms with a site in Switzerland are open now. Recruiting first, the newest first:

34 more — sign in →

All 40 open studies →

A study can be open while its sites in Switzerland have not opened yet or have stopped. Only those recruiting at a site in Switzerland →

Who these studies take

Of the 1,228 Prostatic Neoplasms studies recruiting now, 927 (75%) set no upper age limit and 76 (6%) stop at 75 or younger; 67 take children under 18; 82 take healthy volunteers.

This study: 50 Years and older · male · healthy volunteers too.

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02

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.

Read the detailed description

This study (VISIONING III) is a prospective, single-center, longitudinal cohort follow-up of the previously completed VISIONING I and II prostate cancer screening phases. It evaluates the long-term safety, diagnostic performance, and negative predictive value of a biparametric MRI (bpMRI)-based opportunistic screening strategy for prostate cancer over a five-year interval. The primary objective is to determine the five-year incidence of clinically significant prostate cancer (csPCa, defined as ISUP grade group ≥2) in men who previously underwent bpMRI-based screening and either: had a negative bpMRI without biopsy indication, had a negative biopsy result, or were diagnosed with low-risk prostate cancer and managed with active surveillance. The central hypothesis is that a negative bpMRI-based screening result provides durable protection against the development of clinically significant prostate cancer over at least five years, demonstrating a high negative predictive value. Additionally, it is hypothesized that systematic re-evaluation after five years will identify a clinically meaningful proportion of previously undetected csPCa in men who meet predefined biopsy criteria. VISIONING III is a prospective, observational, longitudinal cohort study conducted at a single tertiary referral center. It represents the structured five-year follow-up of participants from the VISIONING I/II screening cohorts. No experimental intervention is introduced; all diagnostic procedures follow predefined clinical criteria aligned with current European Association of Urology (EAU) guidelines. The study includes two key timepoints: Baseline: prior bpMRI-based screening (already completed in VISIONING I/II) Follow-up: structured reassessment at approximately five years (VISIONING III). At follow-up, all participants undergo repeat bpMRI and serum PSA testing, including PSA density (PSAD) calculation. Follow-Up Procedures: Participants are reassessed using a standardized protocol: Imaging and Laboratory Testing. Repeat biparametric MRI (bpMRI), classified using PI-RADS (1-5). Serum PSA measurement: PSA density calculation (PSA divided by MRI-derived prostate volume). Biopsy Indications: Biopsy is performed only if predefined criteria are met: PI-RADS ≥4 lesion on bpMRI, or PSA density ≥0.15 ng/ml², or PSA >10 ng/ml, or Persistent or upgraded PI-RADS 3 lesion after 6 months. For PI-RADS 3 lesions: Repeat multiparametric MRI after 6 months. Biopsy only if lesion persists or upgrades. Primary Endpoint: Five-year ISUP ≥2 diagnosis-free survival after initial negative screening round. This measures the proportion of participants remaining free of clinically significant prostate cancer five years after baseline screening. Secondary Endpoints: Treatment-free survival. Time to radical prostatectomy, radiotherapy, focal therapy, or death. Stratified by baseline screening category. Biopsy-free and re-MRI-free survival. Time to any prostate biopsy or repeat MRI after baseline screening. Includes death as censoring event. Diagnostic yield of repeat screening. Detection rates of clinically significant and clinically non-significant prostate cancer. Diagnostic efficiency metrics. Number of MRIs and biopsies needed to detect one csPCa case. Comparison with first screening round (VISIONING I/II). Longitudinal biomarker and imaging changes. Changes in PSA, PSA density, PI-RADS scores over five years. mPredictive value of these changes for csPCa detection. Oncological safety outcomes. Metastasis-free survival. Prostate cancer-specific survival. Morphological prostate changes. Prostate volume, transition zone volume, and structural changes. Association with PSA, age, and cancer outcomes. Outcomes after definitive treatment. Clinical outcomes in participants undergoing surgery, radiotherapy, or focal therapy during follow-up. Independent Variables. Key predictors include: Baseline screening status. MRI-negative without biopsy. MRI-negative with negative biopsy. Low-risk prostate cancer under active surveillance. Repeat bpMRI findings. PI-RADS score (1-5). Lesion size, location, progression. PSA-related measures. PSA level and PSA density at follow-up. PSA kinetics compared to baseline. Biopsy-related variables. Biopsy performed (yes/no). Histopathological outcome (ISUP grade group 1-5). Study Population. Participants are drawn from the original VISIONING I/II cohort. Inclusion is limited to men who previously underwent bpMRI-based screening and did not receive definitive treatment for prostate cancer after the initial screening round (except those on active surveillance for low-risk disease). Study Rationale: Prostate cancer screening using bpMRI as a first-line diagnostic tool has shown promise in reducing unnecessary biopsies while maintaining high detection rates for clinically significant disease. However, long-term data on the durability of a negative bpMRI result are limited. This study addresses this gap by evaluating five-year outcomes, including delayed detection of csPCa, treatment-free survival, and the long-term negative predictive value of bpMRI in a real-world opportunistic screening setting. Additional Considerations: Study is observational and non-interventional. Conducted at a single tertiary center.

Standardized imaging and biopsy criteria ensure internal consistency. No formal patient or public involvement in study design, though iterative improvements were informed by prior cohort feedback.

Participant burden was reduced by removing routine DRE and pre-biopsy questionnaires, based on prior phase experience. Expected Impact: The study aims to provide robust evidence on:

Long-term safety of bpMRI-first prostate cancer screening. Optimal follow-up strategies after negative MRI findings. Efficient use of MRI and biopsy in population-based opportunistic screening. Refinement of risk stratification using PSA, PSA density, and PI-RADS evolution

03

Conditions studied

  • Prostate Cancer

Browse trials for

Keywords

  • Prostate
  • Prostate Cancer
  • Prostate cancer screening
  • Prostate carcinoma
  • Prostate-specific antigen (PSA)
  • MRI-based screening
04

Who can participate

Ages eligible
50 Years and older
Sexes eligible
Male
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

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)
  • \< 10 years
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

05

Study design

Phase
Not applicable
Primary purpose
Screening
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
300 participants (estimated)

Study arms

  • Other
    MRI-Guided screening

    Diagnostic Test: MRI

Interventions

  • Diagnostic testMRI

    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.

06

What researchers measure

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

07

Study locations

1 of 1 sites recruiting
08

References and documents

Study documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2026 (actual). Primary completion is estimated for Jun 2028, 24 months after the start.

Of 1,098 non-industry interventional studies with no phase under Prostatic Neoplasms, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 87. This study's planned 24 months is below that.

Counting every sponsor, half of 1,155 studies reached it within 43 months; a quarter within 22 and three quarters within 86.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 8, 2026
First posted
Aug 13, 2026
StartActual
Jun 1, 2026
Primary completionEst.
Jun 1, 2028
CompletionEst.
Jun 1, 2028
Last update
Aug 13, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 13, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07762911
Responsible party
Sponsor
First posted
Aug 13, 2026
Start date
Jun 1, 2026
Primary completion
Jun 1, 2028 (estimated)
Completion
Jun 1, 2028 (estimated)
Last update
Aug 13, 2026

Study contacts

Cyrill Rentsch, Prof.
Contact
cyrill.rentsch@usb.ch
+41 61 32 87122
Viktor Alargkof, MD
Contact
viktor.alargkof@usb.ch
+4161328725

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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