Clinical trial · Interventional
Real Time MRI Fused to Cone Beam CT Guided Biopsies of the Prostate.
Real Time MRI Fused to Cone Beam CT Guided Biopsies of the Prostate: The Safety and Feasibility of a Novel Method of 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)
The purpose of this study is to investigate a novel method of prostate biopsy using a computerized guidance system to accurately target lesions within the prostate. This method of prostate biopsy involves using a computerized technology that permits a lesion detected on MRI to be projected by a computer into 3 dimensions on a patient's CT scan. A CT guided biopsy can then be performed where a needle is advanced into the patient, where the computer has projected the image of the tumor that cannot normally be seen on CT. This is a randomized, cross over designed trial to compare this new method of prostate biopsy to the currently employed standard transrectal ultrasound guided prostate (TRUSP) biopsy technique.
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 |
|---|---|---|---|
| CT Fusion + Transrectal U/S Guided Prostate Biopsy | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- CT Fusion Biopsy + Transrectal U/S Guided Prostate Biopsy
- description
- All patients will receive both a CT fusion biopsy and a standard TRUSP biopsy. They will be randomized to which is received first, followed by receipt of the alternative procedure.
- interventionNames
- Procedure: CT Fusion + Transrectal U/S Guided Prostate Biopsy
- type
- OTHER
- label
- Transrectal U/S Guided Prostate Biopsy + CT Fusion Biopsy
- description
- All patients will receive both a CT fusion biopsy and a standard TRUSP biopsy. They will be randomized to which is received first, followed by receipt of the alternative procedure.
- interventionNames
- Procedure: CT Fusion + Transrectal U/S Guided Prostate Biopsy
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Participants will be eligible for enrollment if they have both of: 1. Lesion in the prostate on mpMRI that is highly likely to be clinically significant prostate cancer based on the PI-RADS version 2 score (PI-RADS score of 4 or 5). 2. A previous negative TRUSP biopsy or previous TRUSP biopsy showing atypical small acinar proliferation, high grade prostatic intraepithelial neoplasia or low volume Gleason 6 disease (low risk disease) all of which are incongruent with the high PI-RADS score of the mpMRI lesion. Exclusion Criteria: 1. Uncorrected coagulopathy. 2. Active, untreated urinary tract infection. 3. Inability to access the rectum in order to perform TRUSP biopsy.
References
Publications (0)
Data not yet available