Clinical trial · Interventional
Use of Multi-Parametric MRI With Prostate Biopsy for Cancer Diagnosis.
Comparative Analysis of Software-based MRI-Ultrasound Image Fusion Against Cognitive Targeting of Multi-Parametric MRI Findings With Prostate Biopsy
- 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)
This is a prospective single center trial to examine the rates of cancer diagnosis when using computerized software to target suspicious lesions within the prostate identified on mpMRI. The primary evaluation involves comparing the rate of cancer diagnosis when using software-based MRI-Ultrasound image fusion guided biopsy to sample mpMRI findings to the use of visual guided biopsy (cognitive or mental targeting) of the same target. The hypothesis being tested is that fusion guided biopsy will increase detection prostate cancer within mpMRI findings as compared to visual guided biopsy of these areas
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 |
|---|---|---|---|
| Targeted Biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Targeted Biopsy
- description
- Men being evaluated for prostate cancer based upon standard of care clinical parameters (e.g. elevated PSA levels, abnormal DRE, mpMRI) will be considered for enrollment. Men who have undergone prostate mpMRI that has revealed an area(s) of suspicion for prostate cancer are eligible for enrollment. All men enrolled in the study undergo fusion targeted biopsy, visual estimation biopsy, and systematic biopsy. As a result the study includes a single arm with direct comparison of biopsy techniques.
- interventionNames
- Procedure: Targeted Biopsy
Primary outcomes (1)
- measure
- Evaluation of rates of prostate cancer diagnosis
- timeFrame
- One week after biopsy
- description
- The primary endpoint of the study is the evaluation of the rates of prostate cancer diagnosis using software based MRI-TRUS imaging fusion targeting of mpMRI lesions as compared to cognitive co-registration and targeting of mpMRI lesions.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: * No previous diagnosis of adenocarcinoma of the prostate * No contraindication to prostate biopsy (e.g. coagulopathy, medical condition prohibiting abstinence from anti-platelet or anticoagulation therapies, anatomical considerations, anatomical considerations) * Active urinary tract infection Exclusion Criteria: * Prior pelvic radiotherapy * Prior androgen deprivation therapy * Evidence urinary tract infection or significant urinary retention * Prostate instrumentation (e.g. prostate biopsy, transurethral prostate procedure) within 2 months prior to mpMRI. * Contraindication to MRI (severe claustrophobia, indwelling metallic objects incompatible with MRI, pacemaker)
References
Publications (0)
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