Prostate CancerNCT03035487
Urology of Virginia Case Series
A study testing Ultrasound guided prostate exam using SOC ultrasound system, mpMRI guided prostate examination using PI-RADS v2 and High-resolution micro-ultrasound guided prostate biopsy in people with Prostate Cancer and Cancer of the PROSTATE, run by Exact Imaging at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 79 years, men only
- Conditions the study is for
- Prostate Cancer, Cancer of the PROSTATE, Prostatic Neoplasm
- What is being tested?
- Ultrasound guided prostate exam using SOC ultrasound system, mpMRI guided prostate examination using PI-RADS v2 and High-resolution micro-ultrasound guided prostate biopsy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2016to Feb 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 79 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- PSA<50
- Clinical stage < cT2c
Who cannot join
- Patients will be excluded from being included in the investigation if any of the following is true:
- Men undergoing TRUS-guided prostate biopsy in the OR under anesthesia
- Men with known prostate volume (from prior imaging) of > 60cc
- Men with anorectal abnormalities preventing TRUS-guided prostate biopsy
- Men who are unable to provide their own informed consent
- Men who have contraindications to MRI or gadolinium chelate contrast
Trial locations and contacts
1 site in 1 country.
About this study
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).
Read more
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.
Read the 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.
- Conditions
- Prostate Cancer, Cancer of the PROSTATE, Prostatic Neoplasm
- Being tested
- Ultrasound guided prostate exam using SOC ultrasound system, mpMRI guided prostate examination using PI-RADS v2, High-resolution micro-ultrasound guided prostate biopsy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound guided prostate exam using SOC ultrasound systemDevice
mpMRI guided prostate examination using PI-RADS v2Device
mpMRI guided prostate examination using standard of care MRI system
High-resolution micro-ultrasound guided prostate biopsyDevice
Also called ExactVu micro-ultrasound imaging system
| Study group | Role | What they receive |
|---|---|---|
| Micro-ultrasound | Experimental | 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 Receives: Device: Ultrasound guided prostate exam using SOC ultrasound system; Device: mpMRI guided prostate examination using PI-RADS v2; Device: High-resolution micro-ultrasound guided prostate biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: For each patient, keywords will be assigned within one week following the patient's procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2017 (estimated)
- Study startDec 2016
- Primary completionDec 2016
- Study completionFeb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Exact Imaging
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03035487
- Sponsor's protocol ID
- 2016-UHR-001
- Status last verified
- Apr 2019
- First submitted
- 16 Jan 2017
- Last updated
- 15 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Urology of Virginia Case Series
- ClinicalTrials.gov ID
- NCT03035487
- Acronym / sponsor ID
- 2016-UHR-001
- Conditions
- Prostate Cancer, Cancer of the PROSTATE, Prostatic Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Exact ImagingIndustry (pharma, biotech, devices)
- Study start
- Dec 2016
- Primary completion
- Dec 2016 (actual)
- Study completion
- Feb 2018 (actual)
- First posted
- 30 Jan 2017 (estimated)
- Results
- Posted 4 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Micro-ultrasound | Experimental | Device: Ultrasound guided prostate exam using SOC ultrasound system, Device: mpMRI guided prostate examination using PI-RADS v2, Device: High-resolution micro-ultrasound guided prostate biopsyTransrectal 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 |
Who may qualify
- Ages
- 40 to 79 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
- PSA<50
- Clinical stage < cT2c
Key exclusion criteria (6 listed)
- Patients will be excluded from being included in the investigation if any of the following is true:
- Men undergoing TRUS-guided prostate biopsy in the OR under anesthesia
- Men with known prostate volume (from prior imaging) of > 60cc
- Men with anorectal abnormalities preventing TRUS-guided prostate biopsy
- Men who are unable to provide their own informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ultrasound guided prostate exam using SOC ultrasound system | Device | Micro-ultrasound |
| mpMRI guided prostate examination using PI-RADS v2mpMRI guided prostate examination using standard of care MRI system | Device | Micro-ultrasound |
| High-resolution micro-ultrasound guided prostate biopsyAlso: ExactVu micro-ultrasound imaging system | Device | Micro-ultrasound |
Primary outcome
Keyword Description of Each Biopsy Sample
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound guided prostate exam using SOC ultrasound system, mpMRI guided prostate examination using PI-RADS v2 and High-resolution micro-ultrasound guided prostate biopsy in people with Prostate Cancer and Cancer of the PROSTATE, run by Exact Imaging at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 4 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Keyword Description of Each Biopsy Sample (time frame: For each patient, keywords will be assigned within one week following the patient's procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 May 2019.