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

Primary Purpose

Prostate Disease, Elevated Prostate Specific Antigen, Family History of Prostate Cancer

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Prostate Biopsy
MR US Fusion Guided Prostate Biopsy
MR/TRUS Fusion Guided Prostate Biopsy
Sponsored by
Ardeshir Rastinehad
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Disease focused on measuring Prostate Cancer, Prostate Biopsy, Prostate MRI, Targeted Prostate Biopsy, Fusion Biopsy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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.

Sites / Locations

  • The Smith Institute for UrologyRecruiting
  • The Smith Institute for Urology at Lenox HillRecruiting
  • Manhattan Eye, Ear, and Throat Hospital (MEETH)Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Males with Prostate Cancer

Arm Description

Each participant will receive standard of care ultrasound guided prostate biopsy and a MR/TRUS Fusion Guided prostate biopsy.

Outcomes

Primary Outcome Measures

Incidence of Prostate Cancer
Incidence of diagnosing subjects with prostate cancer with MR visible lesions

Secondary Outcome Measures

Incidence of adverse events
the incidence of adverse events occurring after a targeted and ultrasound guided prostate biopsy
Pirads score
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
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.

Full Information

First Posted
October 16, 2020
Last Updated
January 27, 2023
Sponsor
Ardeshir Rastinehad
Collaborators
Philips Healthcare
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1. Study Identification

Unique Protocol Identification Number
NCT04599218
Brief Title
MR/TRUS Fusion Guided Prostate Biopsy - An Improved Way to Detect and Quantify Prostate Cancer
Official Title
MR/TRUS Fusion Guided Prostate Biopsy - An Improved Way to Detect and Quantify Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 21, 2020 (Actual)
Primary Completion Date
October 15, 2024 (Anticipated)
Study Completion Date
January 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ardeshir Rastinehad
Collaborators
Philips Healthcare

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.
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. The researchers are interested in learning which procedure is more useful in obtaining a diagnosis of prostate cancer which will in turn provide a better diagnosis rate. Each patient will act as their own control.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Disease, Elevated Prostate Specific Antigen, Family History of Prostate Cancer, Positive Digital Rectal Exam, Prostate Cancer
Keywords
Prostate Cancer, Prostate Biopsy, Prostate MRI, Targeted Prostate Biopsy, Fusion Biopsy

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1586 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Males with Prostate Cancer
Arm Type
Experimental
Arm Description
Each participant will receive standard of care ultrasound guided prostate biopsy and a MR/TRUS Fusion Guided prostate biopsy.
Intervention Type
Other
Intervention Name(s)
Prostate Biopsy
Other Intervention Name(s)
Transperineal (TP) Prostate Biopsy, UroNav Fusion Biopsy, Targeted prostate biopsy, Ultrasound guided Prostate Biopsy
Intervention Description
Standard of care
Intervention Type
Other
Intervention Name(s)
MR US Fusion Guided Prostate Biopsy
Other Intervention Name(s)
Fusion Biopsy
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
MR/TRUS Fusion Guided Prostate Biopsy
Intervention Description
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 Measure Information:
Title
Incidence of Prostate Cancer
Description
Incidence of diagnosing subjects with prostate cancer with MR visible lesions
Time Frame
1 Month
Secondary Outcome Measure Information:
Title
Incidence of adverse events
Description
the incidence of adverse events occurring after a targeted and ultrasound guided prostate biopsy
Time Frame
1 Month
Title
Pirads score
Description
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.
Time Frame
1 Month
Title
Gleason score
Description
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.
Time Frame
1 Month

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: All patients must have a pre-operative MRI performed in accordance with Northwell/NIH MR Prostate imaging guidelines or equivalent. 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 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 >1.8 or Abnormal digital rectal exam or current recommendations or biopsy from the American Urological Association. Pre-Biopsy prostate MRI as described above, showing targetable lesions within 4 months of biopsy Able to tolerate an 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 uncorrectable coagulopathies.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ardeshir R Rastinehad, DO
Phone
212-434-6580
Email
Arastine@northwell.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Cynthia Knauer, RN
Phone
646-874-4733
Email
cknauer1@northwell.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ardeshir Rastinehad, DO
Organizational Affiliation
Northwell Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Smith Institute for Urology
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cynthia Knauer, RN
Phone
646-874-4733
Email
cknauer1@northwell.edu
First Name & Middle Initial & Last Name & Degree
Peter Tricarico
Email
ptricarico1@northwell.edu
Facility Name
The Smith Institute for Urology at Lenox Hill
City
New York
State/Province
New York
ZIP/Postal Code
10022
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ardeshir Rastinehad, DO
Phone
212-434-6580
Email
Arastine@northwell.edu
Facility Name
Manhattan Eye, Ear, and Throat Hospital (MEETH)
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ardeshir Rastinehad, DO
Phone
212-434-6580
Email
Arastine@northwell.edu

12. IPD Sharing Statement

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

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