MRI/TRUS Fusion Guided Prostate Biopsy- An Improved Way to Detect and Quantify Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Core Needle TRUS Needle biopsy (Transrectal ultrasound)
Core Needle MRI/US image fusion guided needle biopsy
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer focused on measuring Prostate Cancer, Biopsy
Eligibility Criteria
Inclusion Criteria:
- All patients must have a pre-operative MRI performed in accordance with our NSHSLIJ/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 conscious sedation (if procedure to be performed with conscious sedation, and without general anesthesia).
- 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 2 months of biopsy
- Able to tolerate a TRUS 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.
- Inability to hold breath, if procedure will be performed with conscious sedation, and without general anesthesia.
- Patients with pacemakers or automatic implantable cardiac defibrillators (contraindications to MRI)
- Patients with uncorrectable coagulopathies.
Sites / Locations
- The Arthur Smith Institute for Urology
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Core Needle TRUS biopsy (Transrectal ultrasound)
Core Needle MRI/US fusion guided biopsy
Arm Description
Patient receiving core needle TRUS biopsy (Standard of care biopsy)
Patients receiving Standard of Care core needle TRUS biopsy will then receive the MRI / Ultrasound fusion core needle guided biopsy
Outcomes
Primary Outcome Measures
Number of prostate lesions
To determine if the number of prostate lesions identified by targeted (MR / US fusion biopsy) plus conventional biopsy is statitically greater than the number of lesions identified conventional biopsy alone. The number of positive lesions identified by both techniques will be compared.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01566045
Brief Title
MRI/TRUS Fusion Guided Prostate Biopsy- An Improved Way to Detect and Quantify Prostate Cancer
Official Title
MRI/TRUS Fusion Guided Prostate Biopsy- An Improved Way to Detect and Quantify Prostate Cancer. A Phase III Study
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Withdrawn
Study Start Date
May 2012 (undefined)
Primary Completion Date
April 2015 (Anticipated)
Study Completion Date
April 2015 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Philips Healthcare
4. Oversight
Data Monitoring Committee
Yes
5. 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.
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 with the addition of an endorectal-coil probe and a 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 12-14 core biopsies.
This study will consist of comparison of the standard of care (TRUS guided prostate biopsy) with the protocol biopsy which consists of a TRUS guided prostate biopsy and a MR/US fusion tracked prostate biopsy. 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 Cancer
Keywords
Prostate Cancer, Biopsy
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Core Needle TRUS biopsy (Transrectal ultrasound)
Arm Type
Active Comparator
Arm Description
Patient receiving core needle TRUS biopsy (Standard of care biopsy)
Arm Title
Core Needle MRI/US fusion guided biopsy
Arm Type
Experimental
Arm Description
Patients receiving Standard of Care core needle TRUS biopsy will then receive the MRI / Ultrasound fusion core needle guided biopsy
Intervention Type
Procedure
Intervention Name(s)
Core Needle TRUS Needle biopsy (Transrectal ultrasound)
Other Intervention Name(s)
Core Needle biopsy, TRUS needle biopsy (Transrectal ultrasound)
Intervention Description
Standard of care 12-core TRUS sextant needle biopsy of the medial and lateral margins of the right and left apex, mid-gland and base of the prostate
Intervention Type
Procedure
Intervention Name(s)
Core Needle MRI/US image fusion guided needle biopsy
Other Intervention Name(s)
Core Needle biopsy, MRI/US image fusion guided needle biopsy
Intervention Description
Directed prostate needle biopsies at MR-image identified targets in addition to the standard ultrasound 12-14 core biopsies
Primary Outcome Measure Information:
Title
Number of prostate lesions
Description
To determine if the number of prostate lesions identified by targeted (MR / US fusion biopsy) plus conventional biopsy is statitically greater than the number of lesions identified conventional biopsy alone. The number of positive lesions identified by both techniques will be compared.
Time Frame
Day 1
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
All patients must have a pre-operative MRI performed in accordance with our NSHSLIJ/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 conscious sedation (if procedure to be performed with conscious sedation, and without general anesthesia).
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 2 months of biopsy
Able to tolerate a TRUS 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.
Inability to hold breath, if procedure will be performed with conscious sedation, and without general anesthesia.
Patients with pacemakers or automatic implantable cardiac defibrillators (contraindications to MRI)
Patients with uncorrectable coagulopathies.
Facility Information:
Facility Name
The Arthur Smith Institute for Urology
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
12. IPD Sharing Statement
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MRI/TRUS Fusion Guided Prostate Biopsy- An Improved Way to Detect and Quantify Prostate Cancer
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