Clinical trial · Interventional
A Prospective Study to Evaluate MRI Guided Biopsy Compared With Transrectal Ultrasound Guided Biopsy of the Prostate in Men With Increased PSA Values
NCT01553838CI-TRIAL-00015414completedN/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 determine whether MRI guided prostate biopsy achieves higher prostate cancer detection rates compared with transrectal ultrasound guided prostate biopsy in patients with increased PSA values \> 4.0 ng/ml.
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 |
|---|---|---|---|
| MRI guided prostate biopsy and TRUS guided biopsy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Sequentially MRI guided and TRUS guided biopsy
- description
- Targeted MRI guided biopsy according to findings in a multiparametric MRI followed by transrectal guided biopsy
- interventionNames
- Device: MRI guided prostate biopsy and TRUS guided biopsy
Primary outcomes (1)
- measure
- Prostate cancer detection rate
- timeFrame
- 3 years
Secondary outcomes (1)
- measure
- Number of Participants with Adverse Events as a measure of Safety and Tolerability
- timeFrame
- 3 years
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * PSA \> 4.0 ng/ml * written informed consent * age \>18 Exclusion Criteria: * patients with prostate cancer * patients with prior prostate biopsy * patients with contraindications against MRI or biopsy
References
Publications (0)
Data not yet available
No reference posted for this study.