Cancer of the PROSTATE, Prostate Cancer, Prostatic Neoplasm
Conditions
Brief summary
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.
Detailed description
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.
Interventions
DEVICEUltrasound guided prostate exam using SOC ultrasound system
DEVICEmpMRI guided prostate examination using PI-RADS v2
mpMRI guided prostate examination using standard of care MRI system
DEVICEHigh-resolution micro-ultrasound guided prostate biopsy
Sponsors
Exact Imaging
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
40 Years to 79 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Keyword Description of Each Biopsy Sample | For each patient, keywords will be assigned within one week following the patient's procedure. | 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. Keywords will be derived from standard lexicons such as PI-RADS for MRI and PRI-MUS for Micro-Ultrasound. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Micro-ultrasound Transrectal micro-ultrasound guided prostate biopsy, where images will be compared with images from standard of care modalities:
* Low resolution transrectal ultrasound examination (LR-TRUS)
* Multi-parametric MRI (mpMRI) examination performed according to the PI-RADS v2 protocol
Ultrasound guided prostate exam using SOC ultrasound system
mpMRI guided prostate examination using PI-RADS v2: mpMRI guided prostate examination using standard of care MRI system
High-resolution micro-ultrasound guided prostate biopsy | 9 |
| Total | 9 |
Baseline characteristics
| Characteristic | Micro-ultrasound | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 6 Participants | — |
| Age, Categorical Between 18 and 65 years | 3 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 9 participants | — |
| Sex: Female, Male Female | 0 Participants | — |
| Sex: Female, Male Male | 9 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 0 / 9 |
| serious Total, serious adverse events | 0 / 9 |
Outcome results
Primary
Keyword Description of Each Biopsy Sample
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. Keywords will be derived from standard lexicons such as PI-RADS for MRI and PRI-MUS for Micro-Ultrasound.
Time frame: For each patient, keywords will be assigned within one week following the patient's procedure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Micro-ultrasound | Keyword Description of Each Biopsy Sample | 89 percentage significant cancers detected |