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MR/TRUS Fusion Guided Prostate Biopsy - An Improved Way to Detect and Quantify Prostate Cancer

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ClinicalTrials.gov Identifier: NCT04599218
Recruitment Status : Recruiting
First Posted : October 22, 2020
Last Update Posted : January 25, 2022
Sponsor:
Collaborator:
Philips Healthcare
Information provided by (Responsible Party):
Ardeshir Rastinehad, Northwell Health

Study Description
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Brief Summary:

This research study is designed to determine if targeted Magnetic Resonance Imaging (MRI) Ultrasound (US) fusion biopsy is better than the standard of care ultrasound guided biopsy alone in diagnosing subjects with clinically significant prostate cancer with MRI visible lesions. This study will consist of comparing the standard of care (ultrasound guided prostate biopsy) with the protocol biopsy which consists of an ultrasound guided prostate biopsy and a MRI/US fusion tracked prostate biopsy. There are two biopsy approaches we are testing.

Patients will have a choice to be enrolled into the transrectal (TRUS) or transperineal (TP) arms at their discretion.


Condition or disease Intervention/treatment Phase
Prostate Disease Elevated Prostate Specific Antigen Family History of Prostate Cancer Positive Digital Rectal Exam Prostate Cancer Other: Prostate Biopsy Other: MR US Fusion Guided Prostate Biopsy Device: MR/TRUS Fusion Guided Prostate Biopsy Not Applicable

Detailed Description:

The efficacy of targeting lesions for ultrasound-guided biopsy, surgery,or ablation may be limited by the visibility of a target during the procedure. The successful outcome of the intervention depends upon accurate device placement.

Historically, prostate cancer was diagnosed by finger guided trans-rectal prostate biopsies. However, with the advent of PSA screening and improvements in ultrasonography, ultrasound guided prostate biopsy has become the standard of care to screen and diagnose men with prostate cancer. A standard 12-14 core prostate biopsy is now common practice, detecting cancer in 27% to 44% of patients in patients with an elevated serum PSA.

Initially, prostate MR imaging was not considered for routine clinical practice. However, the addition of an endorectal-coil probe and a 3 Tesla magnet has improved its diagnostic utility. Currently, most mpMRI are done without the use of an endo-rectal coil at 3Tesla. The MRI is able to evaluate the entire prostate (transrectal ultrasound images are overlaid on a previously obtained prostate MRI, combined with an electromagnetic tracking system) prior to biopsy and allows the physician to target specific areas of the prostate that are suspicious for cancer. This contrasts with the typical US guided approach which samples regions of the prostate in a standard fashion.

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 in patients undergoing the transrectal (TR) or transperineal (TP) biopsy approaches. The researchers are interested in learning which procedure is more useful in obtaining a clearer picture of the prostate which will in turn provide a better way of finding abnormalities. Each patient will act as their own control.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1586 participants
Allocation: N/A
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 : August 21, 2020
Estimated Primary Completion Date : October 15, 2024
Estimated Study Completion Date : January 15, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Males with Prostate Cancer
Each participant will receive standard of care prostate biopsy as well as an ultrasound guided prostate biopsy and a MR/TRUS Fusion Guided prostate biopsy.
 Other: Prostate Biopsy
Standard of care
Other Names:
  • Transrectal (TRUS) Prostate Biopsy
  • Transperineal (TP) Prostate Biopsy
  • UroNav Fusion Biopsy
  • Targeted prostate biopsy

Other: MR US Fusion Guided Prostate Biopsy
Trans-rectal ultrasound (TRUS) guided fusion prostate biopsy (Arm 1) or a Transperineal Ultrasound guided fusion prostate biopsy (Arm 2). All patients will under go a standard ultrasound guided biopsy at the time of their targeted (fusion) 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.


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Prostate Cancer [ Time Frame: 1 Month ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  1. All patients must have a pre-operative MRI performed in accordance with Northwell/NIH MR Prostate imaging guidelines or equivalent.
  2. Age greater than 18 years.
  3. No serious concurrent medical illness that would preclude the patient from making a rational informed decision on participation.
  4. The ability to understand willingness to sign a written informed consent form, and to comply with the protocol. If in question, an ethics consult will be obtained.
  5. Ability to tolerate sedation and or general anesthesia if required.
  6. PSA >1.8 or Abnormal digital rectal exam or current recommendations or biopsy from the American Urological Association.
  7. Pre-Biopsy prostate MRI as described above, showing targetable lesions within 4 months of biopsy
  8. Able to tolerate an ultrasound guided biopsy.

Exclusion Criteria:

  1. Patients with an altered mental status that precludes understanding or consenting for the biopsy procedure will be excluded from this study
  2. Patients unlikely able to hold reasonably still on a procedure table for the length of the procedure
  3. Patients with pacemakers or automatic implantable cardiac defibrillators (contraindications to MRI)
  4. Patients with uncorrectable coagulopathies.
Contacts and Locations
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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): NCT04599218


Contacts
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Contact: Ardeshir R Rastinehad, DO 212-434-6580 Arastine@northwell.edu
Contact: Monica K Johnson, RN 516-734-8515 Mjohnson7@northwell.edu

Locations
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United States, New York
The Smith Institute for Urology Recruiting
Lake Success, New York, United States, 11042
Contact: Monica Johnson, RN    516-734-8515    Mjohnson7@northwell.edu   
The Smith Institute for Urology at Lenox Hill Recruiting
New York, New York, United States, 10022
Contact: Ardeshir Rastinehad, DO    212-434-6580    Arastine@northwell.edu   
Manhattan Eye, Ear, and Throat Hospital (MEETH) Recruiting
New York, New York, United States, 10065
Contact: Ardeshir Rastinehad, DO    212-434-6580    Arastine@northwell.edu   
Sponsors and Collaborators
Ardeshir Rastinehad
Philips Healthcare
More Information
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Responsible Party: Ardeshir Rastinehad, Associate Professor of Urology and Radiology, Vice Chair of Urology at Lenox Hill Hospital, System Director for Prostate Cancer, Northwell Health
ClinicalTrials.gov Identifier: NCT04599218    
Other Study ID Numbers: 20-0384
First Posted: October 22, 2020    Key Record Dates
Last Update Posted: January 25, 2022
Last Verified: January 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Ardeshir Rastinehad, Northwell Health:
Prostate Cancer
Prostate Biopsy
Prostate MRI
Targeted Prostate Biopsy
Fusion Biopsy
Additional relevant MeSH terms:
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Prostatic Neoplasms
Prostatic Diseases
Genital Neoplasms, Male
 Urogenital Neoplasms
Neoplasms by Site
Neoplasms