Clinical trial · Interventional
Evaluation of a MRI-based Prostate Cancer Screening Program
NCT03749993CI-TRIAL-00066606VISIONINGcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to evaluate the effort and resources (incl. costs) required to detect 20 clinically relevant prostate cancer (PCA) in a screening program based on bpMRI of the prostate.
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 |
|---|---|---|---|
| Screening | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Screening Arm
- description
- Screening
- interventionNames
- Other: Screening
Primary outcomes (1)
- measure
- Total costs of the MRI based prostate cancer screening
- timeFrame
- 24 months
- description
- Total costs of the program
Secondary outcomes (11)
- measure
- Comparison of costs of classical screening based on PSA and DRE
- timeFrame
- 24 months
- description
- Total costs per patient
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 46 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * well-informed men with the wish for prostate cancer screening * prostate biopsy naïve * life expectancy \> 10 years * men \> 50 years of age * men \> 45 years of age with a family history of prostate cancer * African-Americans \> 45 years of age Exclusion Criteria: * prostate biopsy performed prior to study * life expectancy \< 10 years * acute urinary tract infection * NIH-CPSI score 19 (leads to initiation of urologic diagnostics and treatment) * IPSS score 20 (leads to initiation of urologic diagnostics and treatment) Contraindications for MRI: * Heart pacemaker * Artificial heart valves (some types are eligible) * Cochlea implant * ICD * Metallic foreign bodies/devices/implants (neuro-stimulator, pain or insulin pump, etc.) * Severe claustrophobia
References
Publications (1)
- DERIVEDWetterauer C, Matthias M, Pueschel H, Deckart A, Bubendorf L, Mortezavi A, Arbelaez E, Jean Winkel D, Heye T, Boll DT, Merkle E, Hayoz S, Seifert HH, Rentsch CA. Opportunistic Prostate Cancer Screening with Biparametric Magnetic Resonance Imaging (VISIONING). Eur Urol Focus. 2024 Mar;10(2):332-338. doi: 10.1016/j.euf.2024.02.006. Epub 2024 Feb 23. PMID 38402105