MR/TRUS Fusion Guided Prostate Biopsy
Study Details
Study Description
Brief Summary
This study will determine if targeted (Magnetic Resonance (MR) / Ultrasound (US) fusion biopsy) plus conventional biopsy is superior to conventional biopsy alone in diagnosing subjects with prostate cancer.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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N/A |
Detailed Description
The efficacy of targeting lesions for surgery may be limited by the visibility of a target during the procedure. The successful outcome of surgical intervention depends upon accurate device placement, which may be very challenging in certain settings, such as when a kidney tumor only is visible for a brief moment during the transient arterial phase of a contrast injection, and soon disappearing on dynamic imaging.
Historically, prostate cancer was diagnosed by digitally guided trans-rectal prostate biopsies. With PSA (Prostate Specific Antigen) screening and improvements in ultrasonography, trans-rectal ultrasound (TRUS) guided prostate biopsy have become the standard of care to screen and diagnose localized prostate cancer. Standard US 12-14 core prostate biopsy is now common practice, detecting cancer in 27% to 44% of patients.
Prostate MR imaging at 3 Tesla magnet dramatically improves diagnostic utility dramatically but biopsies are difficult, time-consuming, and require specialized equipment, which increases the cost significantly.
To meet this challenge TRUS images are overlaid on a previously obtained prostate MRI, combined with an electromagnetic tracking system. The urologist then performs directed prostate biopsies at MR-identified targets in addition to the standard prostate biopsies.
This study will consist of comparison of the standard of care prostate biopsy with the protocol biopsy which consists of a US guided prostate biopsy and a MR/US fusion tracked prostate biopsy. Each patient will act as their own control.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Males with Prostate Cancer Each participant will receive standard of care prostate biopsy as well as a US guided prostate biopsy and a MR/TRUS Fusion Guided prostate biopsy guided prostate biopsy. |
Procedure: prostate biopsy
standard of care
Procedure: MR US Fusion Guided Prostate Biopsy
Trans-rectal ultrasound (TRUS) guided fusion prostate biopsy, Transperineal Ultrasound guided fusion prostate biopsy
Other Names:
Device: MR/TRUS Fusion Guided Prostate Biopsy
TRUS images are overlaid on a previously obtained prostate MRI, combined with an electromagnetic tracking system. The urologist then performs directed prostate biopsies at MR-identified targets in addition to the standard prostate biopsies.
|
Outcome Measures
Primary Outcome Measures
- Incidence of Prostate Cancer [Day 0 - day of procedure]
Incidence of diagnosing subjects with prostate cancer with MR visible lesions
Secondary Outcome Measures
- Incidence of adverse events [1 month]
the incidence of adverse events occurring after a targeted and ultrasound guided prostate biopsy
- Pirads score [1 month]
The Prostate Imaging Reporting and Data System (PIRADS) score classifies MRI lesions on a scale from 1 to 5, which reflects their level of suspicion from least to most. Higher score indicates more suspicion.
- Gleason score [1 month]
The Gleason Score ranges from 1-5 and describes how much the cancer from a biopsy looks like healthy tissue (lower score) or abnormal tissue (higher score). Sum of the gleason grade of the most predominant tumor pattern and a second gleason grade of the second most predominant pattern. Full score from 2 to 10, with higher score indicating more clinically significance.
Eligibility Criteria
Criteria
Inclusion Criteria:
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All patients must have a pre-operative MRI performed in accordance with the MT Sinai/NIH MR prostate imaging guidelines.
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Age greater than 18 years.
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No serious concurrent medical illness that would preclude the patient from making a rational informed decision on participation.
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The ability to understand and willingness to sign a written informed consent form, and to comply with the protocol. If in question, an ethics consult will be obtained.
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Ability to tolerate sedation and or general anesthesia if required.
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PSA >2.5 or Abnormal digital rectal exam or current recommendations for biopsy from the American Urological Association
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Pre-biopsy prostate MRI as described above, showing targetable lesions within 4 months of biopsy
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Able to tolerate a ultrasound guided biopsy
Exclusion Criteria:
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Patients with an altered mental status that precludes understanding or consenting for the biopsy procedure will be excluded from this study.
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Patients unlikely able to hold reasonably still on a procedure table for the length of the procedure.
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Patients with pacemakers or automatic implantable cardiac defibrillators (contraindications to MRI)
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Patients with uncorrectable coagulopathies.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Icahn School of Medicine at Mount Sinai | New York | New York | United States | 11101 |
Sponsors and Collaborators
- Icahn School of Medicine at Mount Sinai
- Philips Healthcare
Investigators
- Principal Investigator: Ardeshir Rastinehad, DO, Icahn School of Medicine at Mount Sinai
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- GCO 15-0768