Clinical trial · Observational
Detection Rate of Prostate Cancer in Men Undergoing MRI
A Retrospective Observational Study to Assess Prostate Cancer Detection Rate in Men Undergoing Magnetic Resonance Imaging: Comparison Between Subjects With Previous Negative Biopsy and Biopsy Naive Men
- 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)
To assess prostate cancer (PCa) detection rate in men undergoing magnetic resonance imaging (MRI) before planning prostate biopsy. Results will be stratified considering men with/without previous negative prostate biopsy. Secondary objective will be to compute the negative predictive value of MRI in subject with no lesion detected at imaging or no cancer confirmed at biopsy, considering a follow-up of at least 2 years.
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 |
|---|---|---|---|
| Prostatic Neoplasm | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| multiparametric MRI | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Group A (previous negative biopsy)
- description
- Men with clinical suspicion of PCa, previous negative prostate biopsy who underwent prostate MRI
- interventionNames
- Diagnostic Test: multiparametric MRI
- label
- Group B (biopsy naive)
- description
- Men with clinical suspicion of PCa, no previous negative prostate biopsy who underwent prostate MRI
- interventionNames
- Diagnostic Test: multiparametric MRI
Primary outcomes (1)
- measure
- PCa detection rate
- timeFrame
- 24 months
- description
- Number of men with positive prostate biopsy over the number of men with a positive MRI
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 50 Years
Show eligibility criteria text
Inclusion Criteria: * age 50 and life expectancy greater than 10 years * PSA values persistently greater than 4 ng/ml * multiparametric MRI of the prostate between nov-2014 and nov-2016 * MRI with endorectal coil Exclusion Criteria: * previous history of PCa
References
Publications (0)
Data not yet available