Prostate Cancer
Conditions
Brief summary
The goal of this study is to use a clinical micro-ultrasound to systematically image the prostate before biopsy or surgery. The images from the ultrasound system will be saved and compared to other imaging modalities and pathology in order to develop better tools.
Interventions
DEVICEExactVu
clinical micro-ultrasound, imaging Device, Manufacturer; Exact Imaging
Sponsors
Stanford University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 89 Years
Healthy volunteers
No
Inclusion criteria
* Scheduled for MR-US fusion prostate biopsy or radical prostatectomy * Agree to consent to the study
Exclusion criteria
* Does not agree to consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Micro-Ultrasound Detection of High Grade Prostate Cancer (Gleason Score ≥7) vs. Surgical Pathology | From date of micro ultrasound exam until the date of Prostate biopsy data are obtained (average of 7 days) | Evaluate the ability of micro-ultrasound to identify high grade prostate cancer foci (Gleason score ≥7) in comparison to final surgical pathology result (prostatectomy or biopsy) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prostate Cancer Border Identification Post-Prostatectomy | 3 years | Evaluate the ability of micro-ultrasound to identify the borders of prostate cancer foci in comparison to final surgical pathology result in men after prostatectomy. |
| Micro-Ultrasound Detection of Low Grade Prostate Cancer (Gleason Score 6) | 1 year and 10 months | Evaluate the ability of micro-ultrasound to detect low grade prostate cancer foci (Gleason score 6) |
| Prostate Cancer Detection: Micro-Ultrasound vs. mpMRI Comparison | 1 year and 10 months | Comparison of prostate cancer detection between micro-ultrasound and multiparametric magnetic resonance imaging (mpMRI). |
| Measuring Correlation Between Prostatectomy Pathology and Imaging Correlation | 3 years | Perform a detailed pathologic and imaging correlation between findings on micro-ultrasound, MRI and final surgical histopathology in men who undergo prostatectomy |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORGeoffrey Sonn
Stanford Universiy
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| ExactVu Imaging EV29L transducer will be inserted in the subject's rectum. Cine sweeps will be performed to save images of:
1. The entire prostate from posterior to anterior (may require 2 sweeps to cover base and apex)
2. The peripheral zone using the highest zoom setting (30mm depth) on the system (may require 2 sweeps to cover base and apex). Analysis of these images will be performed after surgery but before prostatectomy
ExactVu: clinical micro-ultrasound, imaging Device, Manufacturer; Exact Imaging | 95 |
| Total | 95 |
Baseline characteristics
| Characteristic | ExactVu Imaging |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 50 Participants |
| Age, Categorical Between 18 and 65 years | 45 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 85 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 5 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 13 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 14 Participants |
| Race (NIH/OMB) White | 62 Participants |
| Region of Enrollment United States | 95 participants |
| Sex: Female, Male Female | 0 Participants |
| Sex: Female, Male Male | 95 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 95 |
| other Total, other adverse events | 0 / 95 |
| serious Total, serious adverse events | 0 / 95 |
Outcome results
Primary
Micro-Ultrasound Detection of High Grade Prostate Cancer (Gleason Score ≥7) vs. Surgical Pathology
Evaluate the ability of micro-ultrasound to identify high grade prostate cancer foci (Gleason score ≥7) in comparison to final surgical pathology result (prostatectomy or biopsy)
Time frame: From date of micro ultrasound exam until the date of Prostate biopsy data are obtained (average of 7 days)
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ExactVu Imaging | Micro-Ultrasound Detection of High Grade Prostate Cancer (Gleason Score ≥7) vs. Surgical Pathology | Sensitivity (All Lesions) | 38 participants |
| ExactVu Imaging | Micro-Ultrasound Detection of High Grade Prostate Cancer (Gleason Score ≥7) vs. Surgical Pathology | Sensitivity (Excluding Anterior Lesions) | 50 participants |
Secondary
Measuring Correlation Between Prostatectomy Pathology and Imaging Correlation
Perform a detailed pathologic and imaging correlation between findings on micro-ultrasound, MRI and final surgical histopathology in men who undergo prostatectomy
Time frame: 3 years
Secondary
Micro-Ultrasound Detection of Low Grade Prostate Cancer (Gleason Score 6)
Evaluate the ability of micro-ultrasound to detect low grade prostate cancer foci (Gleason score 6)
Time frame: 1 year and 10 months
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| ExactVu Imaging | Micro-Ultrasound Detection of Low Grade Prostate Cancer (Gleason Score 6) | Inter-Reader Agreement | 22 percentage of agreement |
| ExactVu Imaging | Micro-Ultrasound Detection of Low Grade Prostate Cancer (Gleason Score 6) | Positive Percent Agreement for Low-Grade Cancers (Gleason Score 6) | 25.5 percentage of agreement |
Secondary
Prostate Cancer Border Identification Post-Prostatectomy
Evaluate the ability of micro-ultrasound to identify the borders of prostate cancer foci in comparison to final surgical pathology result in men after prostatectomy.
Time frame: 3 years
Secondary
Prostate Cancer Detection: Micro-Ultrasound vs. mpMRI Comparison
Comparison of prostate cancer detection between micro-ultrasound and multiparametric magnetic resonance imaging (mpMRI).
Time frame: 1 year and 10 months
Population: This analysis includes all participants evaluated for prostate cancer detection using micro-ultrasound (MUS) and multiparametric MRI (mpMRI). Metrics include sensitivity and inter-reader agreement (κ values), reported as percentages for consistency
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ExactVu Imaging | Prostate Cancer Detection: Micro-Ultrasound vs. mpMRI Comparison | Average Micro-Ultrasound Sensitivity | 66 percentage of agreement | Standard Error 6.25 |
| ExactVu Imaging | Prostate Cancer Detection: Micro-Ultrasound vs. mpMRI Comparison | Average mpMRI Sensitivity | 90 percentage of agreement | Standard Error 3.97 |
| ExactVu Imaging | Prostate Cancer Detection: Micro-Ultrasound vs. mpMRI Comparison | Average Micro-Ultrasound Inter-Reader Agreement (κ) | 30 percentage of agreement | Standard Error 6.08 |
| ExactVu Imaging | Prostate Cancer Detection: Micro-Ultrasound vs. mpMRI Comparison | Average mpMRI Inter-Reader Agreement (κ) | 50 percentage of agreement | Standard Error 6.63 |