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MR/TRUS Fusion Guided Prostate Biopsy

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ClinicalTrials.gov Identifier: NCT04026763
Recruitment Status : Recruiting
First Posted : July 19, 2019
Last Update Posted : July 19, 2019
Sponsor:
Collaborator:
Philips Healthcare
Information provided by (Responsible Party):
Ardeshir R Rastinehad, Icahn School of Medicine at Mount Sinai

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
Prostate Disease Elevated Prostate Specific Antigen Family History of Prostate Cancer Positive Digital Rectal Exam Procedure: prostate biopsy Procedure: MR US Fusion Guided Prostate Biopsy Device: MR/TRUS Fusion Guided Prostate Biopsy Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 520 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: MR/TRUS Fusion Guided Prostate Biopsy- An Improved Way To Detect And Quantify Prostate Cancer
Actual Study Start Date : May 11, 2018
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


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 Name: Fusion Biopsy

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.




Primary Outcome Measures :
  1. Incidence of Prostate Cancer [ Time Frame: Day 0 - day of procedure ]
    Incidence of diagnosing subjects with prostate cancer with MR visible lesions


Secondary Outcome Measures :
  1. Incidence of adverse events [ Time Frame: 1 month ]
    the incidence of adverse events occurring after a targeted and ultrasound guided prostate biopsy

  2. Pirads score [ Time Frame: 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.

  3. Gleason score [ Time Frame: 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04026763


Contacts
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Contact: Ardeshir Rastinehad, DO 212-241-4812 art.rastinehad@mountsinai.org
Contact: Cynthia Knauer, RN, MS 212-241-0751 cynthia.knauer@mountsinai.org

Locations
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United States, New York
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 11101
Principal Investigator: Ardeshir Rastinehad         
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
Philips Healthcare
Investigators
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Principal Investigator: Ardeshir Rastinehad, DO Icahn School of Medicine at Mount Sinai

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Responsible Party: Ardeshir R Rastinehad, Associate Professor of Radiology and Urology, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT04026763     History of Changes
Other Study ID Numbers: GCO 15-0768
First Posted: July 19, 2019    Key Record Dates
Last Update Posted: July 19, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Ardeshir R Rastinehad, Icahn School of Medicine at Mount Sinai:
Targeted Prostate Biopsy

Additional relevant MeSH terms:
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Prostatic Neoplasms
Prostatic Diseases
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male