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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04299620
Recruitment Status : Recruiting
First Posted : March 9, 2020
Last Update Posted : October 27, 2021
Sponsor:
Collaborators:
Exact Imaging
Phase One Foundation
Information provided by (Responsible Party):
Jonsson Comprehensive Cancer Center

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.

Condition or disease Intervention/treatment Phase
Prostate Carcinoma Device: Digital Image Analysis Procedure: Radical Prostatectomy Procedure: Transrectal Ultrasound Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Micro-Ultrasound to Whole Mount Image Correlation for Detection and Localization of Prostate Cancer
Actual Study Start Date : October 21, 2020
Estimated Primary Completion Date : September 1, 2022
Estimated Study Completion Date : September 1, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Diagnostic (TRUS)
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.
Device: Digital Image Analysis
Analysis of images

Procedure: Radical Prostatectomy
Undergo standard of care radical prostatectomy
Other Name: Prostatovesiculectomy

Procedure: Transrectal Ultrasound
Undergo transrectal ultrasound
Other Names:
  • endorectal ultrasound
  • ERUS (endorectal ultrasound)
  • TRUS




Primary Outcome Measures :
  1. Identification of prostate cancer foci [ Time Frame: Up to 3 years ]

    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 :
  1. Contours of prostate cancer foci [ Time Frame: Up to 3 years ]

    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.



Other Outcome Measures:
  1. Ex vivo and in vivo micro-US images [ Time Frame: Up to 3 years ]
    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).

  2. Suspicion of extracapsular extension (ECE) [ Time Frame: Up to 3 years ]

    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)




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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:

  • 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

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): NCT04299620


Contacts
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Contact: Merdie Delfin 310 794-3566 mdelfin@mednet.ucla.edu

Locations
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United States, California
UCLA / Jonsson Comprehensive Cancer Center Recruiting
Los Angeles, California, United States, 90095
Contact: Merdie Delfin    310-794-3566    mdelfin@mednet.ucla.edu   
Principal Investigator: Leonard S. Marks         
Sponsors and Collaborators
Jonsson Comprehensive Cancer Center
Exact Imaging
Phase One Foundation
Investigators
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Principal Investigator: Leonard S Marks UCLA / Jonsson Comprehensive Cancer Center
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Responsible Party: Jonsson Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT04299620    
Other Study ID Numbers: 19-001136
NCI-2019-05784 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) )
19-001136 ( Other Identifier: UCLA / Jonsson Comprehensive Cancer Center )
First Posted: March 9, 2020    Key Record Dates
Last Update Posted: October 27, 2021
Last Verified: October 2021

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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.: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases