Prostate CarcinomaNCT04299620
Micro-Ultrasound for the Detection and Localization of Prostate Cancer Tumors in Patients Undergoing Radical Prostatectomy
A study testing Digital Image Analysis, Radical Prostatectomy and Transrectal Ultrasound in people with Prostate Carcinoma, run by Jonsson Comprehensive Cancer Center at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Carcinoma
- What is being tested?
- Digital Image Analysis, Radical Prostatectomy and Transrectal Ultrasound
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Oct 2020to 1 Sep 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
UCLA / Jonsson Comprehensive Cancer Center
Los Angeles, California, 90095
About this study
Official title: Micro-Ultrasound to Whole Mount Image Correlation for Detection and Localization of Prostate Cancer
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.
Read the detailed description
PRIMARY OBJECTIVE:
- 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:
- Determine if micro-US can be used to contour prostate cancer foci with equivalent (non-inferior) accuracy to mpMRI.
TERTIARY OBJECTIVE:
- Determine if ex vivo micro-US images have quality comparable to in vivo micro-US images.
QUATERNARY OBJECTIVE:
- 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.
- Conditions
- Prostate Carcinoma
- Being tested
- Digital Image Analysis, Radical Prostatectomy, Transrectal Ultrasound
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Image AnalysisDevice
Analysis of images
Radical ProstatectomyProcedure or surgery
Also called Prostatovesiculectomy
Undergo standard of care radical prostatectomy
Transrectal UltrasoundProcedure or surgery
Also called endorectal ultrasound, ERUS (endorectal ultrasound), TRUS
Undergo transrectal ultrasound
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (TRUS) | Experimental | Patients may undergo 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. Receives: Device: Digital Image Analysis; Procedure: Radical Prostatectomy; Procedure: Transrectal Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of prostate cancer foci
Will be evaluated by comparing sensitivity and positive predictive value of multiparametric magnetic resonance imaging (mpMRI) and micro-ultrasound (US) for identification of prostate cancer (CaP) foci.
Measurement tool = chi squared test
Measured: Up to 3 years
Secondary outcomes (1)
Contours of prostate cancer foci
evaluated by measuring the dice similarity coefficient (DSC) and Hausdorff distances (Hd) between micro-ultrasound (US) and whole mount (WM) tumor contours, and between mpMRI and WM tumor contours. The difference between tumor diameter and volume will be computed between WM and mpMRI, and between WM and US. All measures will then be used to compare accuracy of US versus mpMRI.
Wilcoxon signed-rank tests:
Signed rank tests are nonparametric matched pair tests, here mostly used to compare correlation of mpMRI and WM v. correlation of US and WM. Minimum and maximum input values will depend on the metric being tested; min and max output values will vary between zero and one. A higher output indicates less difference in performance between mpMRI and US. A lower score indicates that more a difference between mpMRI and US. Whether a lower score is a better outcome or worse outcome depends on which modality (mpMRI vs US) is more strongly correlated with WM.
Measured: Up to 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2020
- Study start21 Oct 2020
- Primary completion14 Jun 2022
- Study completion1 Sep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CarcinomaStudies of the same condition, open and under way.
- More trials run by Jonsson Comprehensive Cancer CenterThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jonsson Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Exact Imaging, Phase One Foundation
- Responsible party
- Sponsor
- Investigators
- Leonard S Marks, Principal investigator, UCLA / Jonsson Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04299620
- Sponsor's protocol ID
- 19-001136
- Other IDs
- NCI-2019-05784, 19-001136
- Status last verified
- Oct 2022
- First submitted
- 19 Feb 2020
- Last updated
- 6 Oct 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Micro-Ultrasound to Whole Mount Image Correlation for Detection and Localization of Prostate Cancer
- ClinicalTrials.gov ID
- NCT04299620
- Acronym / sponsor ID
- 19-001136
- Conditions
- Prostate Carcinoma
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Jonsson Comprehensive Cancer CenterUniversity, hospital or other
- Collaborators
- Exact Imaging, Phase One Foundation
- Study start
- 21 Oct 2020 (actual)
- Primary completion
- 14 Jun 2022 (actual)
- Study completion
- 1 Sep 2025 (estimated)
- First posted
- 9 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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:
- Determine if micro-US can be used to contour prostate cancer foci with equivalent (non-inferior) accuracy to mpMRI.
TERTIARY OBJECTIVE:
- Determine if ex vivo micro-US images have quality comparable to in vivo micro-US images.
QUATERNARY OBJECTIVE:
- 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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (TRUS) | Experimental | Device: Digital Image Analysis, Procedure: Radical Prostatectomy, Procedure: Transrectal UltrasoundPatients may undergo 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
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 |
|---|---|---|
| Digital Image AnalysisAnalysis of images | Device | Diagnostic (TRUS) |
| Radical ProstatectomyAlso: ProstatovesiculectomyUndergo standard of care radical prostatectomy | Procedure or surgery | Diagnostic (TRUS) |
| Transrectal UltrasoundAlso: endorectal ultrasound, ERUS (endorectal ultrasound), TRUSUndergo transrectal ultrasound | Procedure or surgery | Diagnostic (TRUS) |
Primary outcome
Identification of prostate cancer foci
Time frame: Up to 3 years
Will be evaluated by comparing sensitivity and positive predictive value of multiparametric magnetic resonance imaging (mpMRI) and micro-ultrasound (US) for identification of prostate cancer (CaP) foci. Measurement tool = chi squared test
1 secondary outcome
Contours of prostate cancer foci
Time frame: Up to 3 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2023.
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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.
Leonard S Marks principal investigator
UCLA / Jonsson Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Image Analysis, Radical Prostatectomy and Transrectal Ultrasound in people with Prostate Carcinoma, run by Jonsson Comprehensive Cancer Center 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 4 inclusion and 4 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: under way, not looking for participants, as of the sponsor's last update on 6 Oct 2023. 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?
This study is still under way. Results are not available in the source record yet.
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?
Identification of prostate cancer foci (time frame: Up to 3 years). 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 6 Oct 2023.