Magnetic Resonance Imaging-Transrectal Ultrasound Fusion Image-Guided Prostate Biopsy Following Radical Prostatectomy in Patients With Prostate Cancer
Primary Purpose
Prostate Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
therapeutic conventional surgery
ultrasound-guided prostate biopsy
magnetic resonance imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- Subjects must have biopsy-proven prostate cancer, or prostate-specific antigen (PSA) >= 4 ng/ml or an abnormal digital rectal examination (DRE) if consented before prostate biopsy
- Subjects must have at least 2, preferably 3, pre-operative magnetic resonance imaging (MRI)-identified malignant or benign lesions that measure between 10 mm and 15 mm in diameter within the prostate
- Subjects must have decided to have their prostate surgically removed
Exclusion Criteria:
- Patients who do not give informed consent
- Patients with extracapsular extension of their prostate cancer
Sites / Locations
- USC Norris Comprehensive Cancer Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Diagnostic (MRI-TRUS fusion image-guided biopsy)
Arm Description
Patients undergo robotic radical prostatectomy, followed by 3 MRI-TRUS fusion image-guided prostate biopsies.
Outcomes
Primary Outcome Measures
Number of times the first biopsy needle is placed within 3.0 mm of the center lesion
A likelihood ratio test will be used to test for independence among lesions within a prostate (corresponding to a lack of systematic MRI-TRUS image distortion and implying that, overall, 1st biopsies to a lesion within one prostate are as likely to accurate as in another prostate).
Number of times the second biopsy needle is placed within 3.0 mm of the center lesion
A likelihood ratio test will be used to test for independence among lesions within a prostate (corresponding to a lack of systematic MRI-TRUS image distortion and implying that, overall, 1st biopsies to a lesion within one prostate are as likely to accurate as in another prostate).
Secondary Outcome Measures
Average distance of the first needle to the center of the lesion
A nested (random effects) analysis of variance (ANOVA) will be used to analyze the distance of the first needle from the center of the lesion. Standard error or 95% confidence interval will be calculated.
Average distance of the second needle from the first needle minus 2.0 mm
A nested (random effects) ANOVA will be used to analyze the distance of the first needle from the center of the lesion.
Average distance of the third needle from the first needle minus 2.0 mm
A nested (random effects) ANOVA will be used to analyze the distance of the first needle from the center of the lesion.
Full Information
NCT ID
NCT01764347
First Posted
December 21, 2012
Last Updated
January 27, 2014
Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT01764347
Brief Title
Magnetic Resonance Imaging-Transrectal Ultrasound Fusion Image-Guided Prostate Biopsy Following Radical Prostatectomy in Patients With Prostate Cancer
Official Title
Accuracy of Targeted Biopsies Using MRI-TRUS Fusion Guidance: Pilot Study on Ex Vivo Radical Prostatectomy Specimens
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
September 2012 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Southern California
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This pilot clinical trial studies magnetic resonance imaging (MRI)-transrectal ultrasound (TRUS) fusion image-guided prostate biopsy following radical prostatectomy in patients with prostate cancer. Diagnostic procedures, such as MRI-TRUS fusion image-guided prostate biopsy may help find and diagnose prostate cancer
Detailed Description
PRIMARY OBJECTIVES:
I. To evaluate accuracy of the new image-guided targeted needle biopsy using the ex-vivo human prostate as obtained from fresh radical prostatectomy specimens.
OUTLINE: Patients undergo robotic radical prostatectomy, followed by 3 MRI-TRUS fusion image-guided prostate biopsies.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diagnostic (MRI-TRUS fusion image-guided biopsy)
Arm Type
Experimental
Arm Description
Patients undergo robotic radical prostatectomy, followed by 3 MRI-TRUS fusion image-guided prostate biopsies.
Intervention Type
Procedure
Intervention Name(s)
therapeutic conventional surgery
Intervention Description
Undergo robotic radical prostatectomy
Intervention Type
Procedure
Intervention Name(s)
ultrasound-guided prostate biopsy
Intervention Description
Undergo MRI-TRUS fusion image-guided prostate biopsy
Intervention Type
Procedure
Intervention Name(s)
magnetic resonance imaging
Other Intervention Name(s)
MRI, NMR imaging, NMRI, nuclear magnetic resonance imaging
Intervention Description
Undergo MRI-TRUS fusion image-guided prostate biopsy
Primary Outcome Measure Information:
Title
Number of times the first biopsy needle is placed within 3.0 mm of the center lesion
Description
A likelihood ratio test will be used to test for independence among lesions within a prostate (corresponding to a lack of systematic MRI-TRUS image distortion and implying that, overall, 1st biopsies to a lesion within one prostate are as likely to accurate as in another prostate).
Time Frame
One month after last patient enrolled is taken off study
Title
Number of times the second biopsy needle is placed within 3.0 mm of the center lesion
Description
A likelihood ratio test will be used to test for independence among lesions within a prostate (corresponding to a lack of systematic MRI-TRUS image distortion and implying that, overall, 1st biopsies to a lesion within one prostate are as likely to accurate as in another prostate).
Time Frame
One month after last patient enrolled is take off study
Secondary Outcome Measure Information:
Title
Average distance of the first needle to the center of the lesion
Description
A nested (random effects) analysis of variance (ANOVA) will be used to analyze the distance of the first needle from the center of the lesion. Standard error or 95% confidence interval will be calculated.
Time Frame
One month after last patient enrolled is taken off study
Title
Average distance of the second needle from the first needle minus 2.0 mm
Description
A nested (random effects) ANOVA will be used to analyze the distance of the first needle from the center of the lesion.
Time Frame
One month after last patient enrolled is taken off study
Title
Average distance of the third needle from the first needle minus 2.0 mm
Description
A nested (random effects) ANOVA will be used to analyze the distance of the first needle from the center of the lesion.
Time Frame
One month after last patient enrolled is taken off study
10. Eligibility
Sex
Male
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects must have biopsy-proven prostate cancer, or prostate-specific antigen (PSA) >= 4 ng/ml or an abnormal digital rectal examination (DRE) if consented before prostate biopsy
Subjects must have at least 2, preferably 3, pre-operative magnetic resonance imaging (MRI)-identified malignant or benign lesions that measure between 10 mm and 15 mm in diameter within the prostate
Subjects must have decided to have their prostate surgically removed
Exclusion Criteria:
Patients who do not give informed consent
Patients with extracapsular extension of their prostate cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Osamu Ukimura
Organizational Affiliation
University of Southern California
Official's Role
Principal Investigator
Facility Information:
Facility Name
USC Norris Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Magnetic Resonance Imaging-Transrectal Ultrasound Fusion Image-Guided Prostate Biopsy Following Radical Prostatectomy in Patients With Prostate Cancer
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