Micro-Ultrasound to Whole Mount Image Correlation for Detection and Localization of Prostate Cancer
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 86
- Locations
- 1
- Primary Endpoint
- Identification of prostate cancer foci
Study Overview
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:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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.
Intervention: Digital Image Analysis (Device)
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.
Intervention: Radical Prostatectomy (Procedure)
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.
Intervention: Transrectal Ultrasound (Procedure)
Outcomes
Primary Outcomes
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 Outcomes
- Contours of prostate cancer foci(Up to 3 years)