Clinical trial NCT04299620: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Prostate Carcinoma
Lead sponsor: Jonsson Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: Exact Imaging
name: Phase One Foundation
First posted: 2020-03-09
Enrollment: 86
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

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

Primary outcomes:
measure: Identification of prostate cancer foci
timeFrame: Up to 3 years
Secondary outcomes:
measure: Contours of prostate cancer foci
timeFrame: Up to 3 years
Other outcomes:
measure: Ex vivo and in vivo micro-US images
timeFrame: Up to 3 years
measure: Suspicion of extracapsular extension (ECE)
timeFrame: Up to 3 years
Locations:
city: Los Angeles
country: United States
facility: UCLA / Jonsson Comprehensive Cancer Center
state: California
Study officials:
affiliation: UCLA / Jonsson Comprehensive Cancer Center
name: Leonard S Marks
role: PRINCIPAL_INVESTIGATOR
References: