Micro-Ultrasound for the Detection and Localization of Prostate Cancer Tumors in Patients Undergoing Radical Prostatectomy
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|ClinicalTrials.gov Identifier: NCT04299620|
Recruitment Status : Recruiting
First Posted : March 9, 2020
Last Update Posted : October 27, 2021
|Condition or disease||Intervention/treatment||Phase|
|Prostate Carcinoma||Device: Digital Image Analysis Procedure: Radical Prostatectomy Procedure: Transrectal Ultrasound||Not Applicable|
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).
I. Determine if micro-US can be used to contour prostate cancer foci with equivalent (non-inferior) accuracy to mpMRI.
I. Determine if ex vivo micro-US images have quality comparable to in vivo micro-US images.
I. Determine if micro-US can be used to evaluate suspicion of extracapsular extension (ECE) with equivalent (non-inferior) accuracy to mpMRI.
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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
- 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
- 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.
- 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).
- 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)
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
|Contact: Merdie Delfin||310 email@example.com|
|United States, California|
|UCLA / Jonsson Comprehensive Cancer Center||Recruiting|
|Los Angeles, California, United States, 90095|
|Contact: Merdie Delfin 310-794-3566 firstname.lastname@example.org|
|Principal Investigator: Leonard S. Marks|
|Principal Investigator:||Leonard S Marks||UCLA / Jonsson Comprehensive Cancer Center|