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Micro-Ultrasound for the Detection and Localization of Prostate Cancer Tumors in Patients Undergoing Radical Prostatectomy

Primary Purpose

Prostate Carcinoma

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Digital Image Analysis
Radical Prostatectomy
Transrectal Ultrasound
Sponsored by
Jonsson Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Prostate Carcinoma

Eligibility Criteria

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

Inclusion Criteria:

  • Standard-of-care mpMRI within the past 12 months
  • Biopsy-proven prostate cancer, Gleason grade >= 3+3
  • Maximum posterior-to-anterior prostate dimension of =< 6 cm
  • Scheduled to receive standard-of-care radical prostatectomy

Exclusion Criteria:

  • Maximum posterior-to-anterior prostate dimension greater than 6 cm
  • Prior radiation or focal treatment for prostate cancer
  • Inability to have a transrectal ultrasound scan
  • Prostate biopsy < 4 weeks prior to surgery

Sites / Locations

  • UCLA / Jonsson Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Diagnostic (TRUS)

Arm Description

Patients may undergo TRUS prior to standard-of-care radical prostatectomy. Following radical prostatectomy, removed glands are scanned and micro-US, standard of care mpMRI, and whole mount images are analyzed and compared.

Outcomes

Primary Outcome Measures

Identification of prostate cancer foci
Will be evaluated by comparing sensitivity and positive predictive value of multiparametric magnetic resonance imaging (mpMRI) and micro-ultrasound (US) for identification of prostate cancer (CaP) foci. Measurement tool = chi squared test

Secondary Outcome Measures

Contours of prostate cancer foci
evaluated by measuring the dice similarity coefficient (DSC) and Hausdorff distances (Hd) between micro-ultrasound (US) and whole mount (WM) tumor contours, and between mpMRI and WM tumor contours. The difference between tumor diameter and volume will be computed between WM and mpMRI, and between WM and US. All measures will then be used to compare accuracy of US versus mpMRI. Wilcoxon signed-rank tests: Signed rank tests are nonparametric matched pair tests, here mostly used to compare correlation of mpMRI and WM v. correlation of US and WM. Minimum and maximum input values will depend on the metric being tested; min and max output values will vary between zero and one. A higher output indicates less difference in performance between mpMRI and US. A lower score indicates that more a difference between mpMRI and US. Whether a lower score is a better outcome or worse outcome depends on which modality (mpMRI vs US) is more strongly correlated with WM.

Full Information

First Posted
February 19, 2020
Last Updated
October 4, 2023
Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
Exact Imaging, Phase One Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04299620
Brief Title
Micro-Ultrasound for the Detection and Localization of Prostate Cancer Tumors in Patients Undergoing Radical Prostatectomy
Official Title
Micro-Ultrasound to Whole Mount Image Correlation for Detection and Localization of Prostate Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 21, 2020 (Actual)
Primary Completion Date
June 14, 2022 (Actual)
Study Completion Date
September 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Jonsson Comprehensive Cancer Center
Collaborators
Exact Imaging, Phase One Foundation

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.
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This trial studies the ability of micro-ultrasound to detect and characterize prostate cancer tumors in patients undergoing radical prostatectomy (removal of the entire prostate and some of the tissue around it). Usually multiparametric magnetic resonance imaging is used for the detection and targeted therapy of prostate cancer, but its accuracy remains imperfect. Micro-ultrasound may be superior as it provides real-time tumor visualization which may simplify and improve prostate cancer targeted therapy. This may also reduce the need for and substantial costs of radical prostatectomy.
Detailed Description
PRIMARY OBJECTIVE: I. Determine if micro-ultrasound (US) can be used to identify prostate cancer foci with equivalent (non-inferior) performance relative to multiparametric magnetic resonance imaging (mpMRI). SECONDARY OBJECTIVE: I. Determine if micro-US can be used to contour prostate cancer foci with equivalent (non-inferior) accuracy to mpMRI. TERTIARY OBJECTIVE: I. Determine if ex vivo micro-US images have quality comparable to in vivo micro-US images. QUATERNARY OBJECTIVE: I. Determine if micro-US can be used to evaluate suspicion of extracapsular extension (ECE) with equivalent (non-inferior) accuracy to mpMRI. OUTLINE: Patients may undergo transrectal micro-ultrasound scan (TRUS) prior to standard-of-care radical prostatectomy. Following radical prostatectomy, removed glands are scanned and micro-US, standard of care mpMRI, and whole mount images are analyzed and compared.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Carcinoma

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Diagnostic (TRUS)
Arm Type
Experimental
Arm Description
Patients may undergo TRUS prior to standard-of-care radical prostatectomy. Following radical prostatectomy, removed glands are scanned and micro-US, standard of care mpMRI, and whole mount images are analyzed and compared.
Intervention Type
Device
Intervention Name(s)
Digital Image Analysis
Intervention Description
Analysis of images
Intervention Type
Procedure
Intervention Name(s)
Radical Prostatectomy
Other Intervention Name(s)
Prostatovesiculectomy
Intervention Description
Undergo standard of care radical prostatectomy
Intervention Type
Procedure
Intervention Name(s)
Transrectal Ultrasound
Other Intervention Name(s)
endorectal ultrasound, ERUS (endorectal ultrasound), TRUS
Intervention Description
Undergo transrectal ultrasound
Primary Outcome Measure Information:
Title
Identification of prostate cancer foci
Description
Will be evaluated by comparing sensitivity and positive predictive value of multiparametric magnetic resonance imaging (mpMRI) and micro-ultrasound (US) for identification of prostate cancer (CaP) foci. Measurement tool = chi squared test
Time Frame
Up to 3 years
Secondary Outcome Measure Information:
Title
Contours of prostate cancer foci
Description
evaluated by measuring the dice similarity coefficient (DSC) and Hausdorff distances (Hd) between micro-ultrasound (US) and whole mount (WM) tumor contours, and between mpMRI and WM tumor contours. The difference between tumor diameter and volume will be computed between WM and mpMRI, and between WM and US. All measures will then be used to compare accuracy of US versus mpMRI. Wilcoxon signed-rank tests: Signed rank tests are nonparametric matched pair tests, here mostly used to compare correlation of mpMRI and WM v. correlation of US and WM. Minimum and maximum input values will depend on the metric being tested; min and max output values will vary between zero and one. A higher output indicates less difference in performance between mpMRI and US. A lower score indicates that more a difference between mpMRI and US. Whether a lower score is a better outcome or worse outcome depends on which modality (mpMRI vs US) is more strongly correlated with WM.
Time Frame
Up to 3 years
Other Pre-specified Outcome Measures:
Title
Ex vivo and in vivo micro-US images
Description
Differences in in vivo versus ex vivo image quality will be evaluated by testing for systematic differences in tumor contouring accuracy. The measures will be identical to those listed under "secondary outcome measures" above, but for comparison between ex vivo micro ultrasound and in vivo micro ultrasound (instead of MRI).
Time Frame
Up to 3 years
Title
Suspicion of extracapsular extension (ECE)
Description
Micro ultrasound and mpMRI ECE suspicion scores will be compared for ECE-positive tumors. Micro ultrasound and mpMRI ECE suspicion scores will also be compared for ECE-negative tumors. Measurement tool(s) = Wilcoxon signed-rank test and one-sided non-inferiority t-test. Notes on the use of Wilcoxon signed-rank tests: (see outcome 2 description above)
Time Frame
Up to 3 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Standard-of-care mpMRI within the past 12 months Biopsy-proven prostate cancer, Gleason grade >= 3+3 Maximum posterior-to-anterior prostate dimension of =< 6 cm Scheduled to receive standard-of-care radical prostatectomy Exclusion Criteria: Maximum posterior-to-anterior prostate dimension greater than 6 cm Prior radiation or focal treatment for prostate cancer Inability to have a transrectal ultrasound scan Prostate biopsy < 4 weeks prior to surgery
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Leonard S Marks
Organizational Affiliation
UCLA / Jonsson Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
UCLA / Jonsson Comprehensive Cancer Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States

12. IPD Sharing Statement

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Micro-Ultrasound for the Detection and Localization of Prostate Cancer Tumors in Patients Undergoing Radical Prostatectomy

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