Urology of Virginia Case Series
| Status: | Completed |
|---|---|
| Conditions: | Prostate Cancer, Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 40 - 79 |
| Updated: | 3/6/2019 |
| Start Date: | December 2016 |
| End Date: | February 2018 |
The investigational protocol describes a small case series designed to compare three imaging
modalities for use in visualizing prostate cancer.
The three modalities to be tested are: transrectal micro-ultrasound , and conventional
resolution transrectal ultrasound (LR-TRUS) (both as implemented on ExactVu, the
multi-frequency novel micro-ultrasound system under investigation), and multi-parametric MRI
(mpMRI).
These modalities will be used for guiding systematic (standard, random, extended sextant)
plus image-guided targeted prostate biopsies among men with known cancer and an indication
for prostate biopsy.
In the case of mpMRI, biopsy will be performed under micro-ultrasound guidance with the
radiology report used for targeting.
modalities for use in visualizing prostate cancer.
The three modalities to be tested are: transrectal micro-ultrasound , and conventional
resolution transrectal ultrasound (LR-TRUS) (both as implemented on ExactVu, the
multi-frequency novel micro-ultrasound system under investigation), and multi-parametric MRI
(mpMRI).
These modalities will be used for guiding systematic (standard, random, extended sextant)
plus image-guided targeted prostate biopsies among men with known cancer and an indication
for prostate biopsy.
In the case of mpMRI, biopsy will be performed under micro-ultrasound guidance with the
radiology report used for targeting.
This trial will enroll nine men with an indication for a prostate biopsy.
The primary objective of the study is to provide guidance to clinicians who will be using the
ExactVu system on the appearance of suspicious foci, and the difference between the
appearance of these foci in LR-TRUS, mpMRI and transrectal micro-ultrasound images.
The study is being conducted based on the hypothesis that a series of same-subject
comparisons will clearly demonstrate the differences in appearance between the modalities.
Procedures in the study are:
- obtain informed consent for the subject
- image the subject using mpMRI according to the PI-RADS v2 protocol, and obtain
radiologist's report
- perform biopsy procedure using micro-ultrasound (this may be conducted in a separate
subject visit)
- prepare biopsy specimens for pathology
- record all procedure details in a case report form, including pathology and mpMRI
reports
The primary endpoint will be a standardized description using keywords of each biopsy sample
region. These descriptions will be recorded during the blinded readings after the procedure
to avoid added procedure time and will be used to compare appearance between the modalities.
Secondary endpoints are the pathological result of each biopsy sample (Gleason Score and
percentage of cancer in sample), and risk score identified on imaging. Both of these values
are per-sample, with 12 systematic samples per subject plus any additional targeted samples
warranted by standard of care.
The primary objective of the study is to provide guidance to clinicians who will be using the
ExactVu system on the appearance of suspicious foci, and the difference between the
appearance of these foci in LR-TRUS, mpMRI and transrectal micro-ultrasound images.
The study is being conducted based on the hypothesis that a series of same-subject
comparisons will clearly demonstrate the differences in appearance between the modalities.
Procedures in the study are:
- obtain informed consent for the subject
- image the subject using mpMRI according to the PI-RADS v2 protocol, and obtain
radiologist's report
- perform biopsy procedure using micro-ultrasound (this may be conducted in a separate
subject visit)
- prepare biopsy specimens for pathology
- record all procedure details in a case report form, including pathology and mpMRI
reports
The primary endpoint will be a standardized description using keywords of each biopsy sample
region. These descriptions will be recorded during the blinded readings after the procedure
to avoid added procedure time and will be used to compare appearance between the modalities.
Secondary endpoints are the pathological result of each biopsy sample (Gleason Score and
percentage of cancer in sample), and risk score identified on imaging. Both of these values
are per-sample, with 12 systematic samples per subject plus any additional targeted samples
warranted by standard of care.
Inclusion Criteria:
1. All men ≥ 40 years age and <80 years of age with a history of prostate cancer and an
indication for a prostate biopsy will be offered inclusion in the study. Typical
indications for biopsy include abnormal PSA (prostate specific antigen) and/or
abnormal DRE (digital rectal exam) and/or history of prostate cancer.
2. PSA<50
3. Clinical stage < cT2c
Exclusion Criteria:
Patients will be excluded from being included in the investigation if any of the following
is true:
1. Men undergoing TRUS-guided prostate biopsy in the OR under anesthesia
2. Men with known prostate volume (from prior imaging) of > 60cc
3. Men with anorectal abnormalities preventing TRUS-guided prostate biopsy
4. Men who are unable to provide their own informed consent
5. Men who have contraindications to MRI or gadolinium chelate contrast
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