MR/TRUS Fusion Guided Prostate Biopsy

  • STATUS
    Recruiting
  • End date
    Dec 23, 2021
  • participants needed
    520
  • sponsor
    Icahn School of Medicine at Mount Sinai
Updated on 23 January 2021
anesthesia
cancer
MRI
prostate biopsy
transrectal ultrasound

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.

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.

Details
Condition Prostatic disorder, Prostate Disorders, Elevated Prostate Specific Antigen, Family History of Prostate Cancer, Positive Digital Rectal Exam
Treatment Prostate Biopsy, MR US Fusion Guided Prostate Biopsy, MR/TRUS Fusion Guided Prostate Biopsy
Clinical Study IdentifierNCT04026763
SponsorIcahn School of Medicine at Mount Sinai
Last Modified on23 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Are you male?
Do you have any of these conditions: Elevated Prostate Specific Antigen or Prostatic disorder or Family History of Prostate Cancer or Positive Digital Rectal Exam?
Do you have any of these conditions: Positive Digital Rectal Exam or Prostate Disorders or Elevated Prostate Specific Antigen or Prostatic disorder or Family History of Prostate Cancer?
All patients must have a pre-operative MRI performed in accordance with the MT Sinai/NIH MR prostate imaging guidelines
Age greater than 18 years
No serious concurrent medical illness that would preclude the patient from making a rational informed decision on participation
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
Ability to tolerate sedation and or general anesthesia if required
PSA >2.5 or Abnormal digital rectal exam or current recommendations for biopsy from the American Urological Association
Pre-biopsy prostate MRI as described above, showing targetable lesions within 4 months of biopsy
Able to tolerate a ultrasound guided biopsy

Exclusion Criteria

Patients with an altered mental status that precludes understanding or consenting for the biopsy procedure will be excluded from this study
Patients unlikely able to hold reasonably still on a procedure table for the length of the procedure
Patients with pacemakers or automatic implantable cardiac defibrillators (contraindications to MRI)
Patients with uncorrectable coagulopathies
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