Clinical trial · Interventional
Prostate Cancer Detection Screening MRI Protocol
Prostate Cancer Detection Using a Quantitative Screening MRI Protocol
NCT04175730CI-TRIAL-00058996completedN/AResults postedClinicalTrials.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)
Whether a quantitative detection specfic magnetic resonance imaging (MRI) protocol improves prostate cancer (PCa) detection in biopsy naïve men is not adequately studied.
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Ultrasound | Device | — | UNRESOLVED |
| Ultrasound and MRI | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- MRI and Ultrasound
- description
- men with elevated PSA or abnormal DRE for which prostate biopsy is indicated and mpMRI positive for suspected prostate cancer followed by MRI/ultrasound fusion directed prostate needle biopsies
- interventionNames
- Device: Ultrasound and MRI
- type
- OTHER
- label
- Ultrasound
- description
- men with elevated PSA or abnormal DRE for which prostate biopsy is indicated and mpMRI negative for suspected prostate cancer followed by standard ultrasound guided prostate needle biospies
- interventionNames
- Device: Ultrasound
Primary outcomes (5)
- measure
- Number of Participants With Any Grade or High Grade (Gleason Score 7 or Higher) Prostate Cancer as Measured by Histopathology
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: * Adult men between 18 and 80 years of age * Suspected PCa as defined by elevated PSA ≥4 ng/mL and ≤20 ng/mL and/or abnormal DRE as determined by a physician * Ability to provide informed consent Exclusion Criteria: * Prior prostate biopsy * Prior diagnosis of PCa * MRI incompatible implanted medical devices or foreign bodies * Rectal anatomy incompatible with TRUS biopsy * Life expectancy \<10 years as determined by the treating urologist
References
Publications (0)
Data not yet available
No reference posted for this study.