Prostate CarcinomaNCT03013413
Ultrasound-Based Imaging Using the Aixplorer System in Diagnosing Prostate Cancer in Patients Undergoing Biopsy
A study testing Shear Wave Elastography, Ultrasound Elasticity Imaging and Ultrasound-Guided Prostate Biopsy in people with Prostate Carcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.
Trial summary
This clinical trial studies an ultrasound-based imaging procedure called elastography using the Aixplorer system in diagnosing prostate cancer in patients undergoing biopsy. Ultrasound is a non-invasive imaging technique that uses high-frequency sound waves to produce images of internal structures. 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?
- Shear Wave Elastography, Ultrasound Elasticity Imaging and Ultrasound-Guided Prostate Biopsy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2011to May 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Be scheduled for a clinically indicated biopsy of the prostate
- Agree to an ultrasound examination using the Aixplorer system
- Sign an institutional review board (IRB) approved informed consent prior to any study procedures
Who cannot join
- Recent prostate biopsy within 90 days
Trial locations and contacts
1 site in 1 country.
United States1 site
Thomas Jefferson University
Philadelphia, Pennsylvania, 19107
About this study
Official title: Evaluation of the Aixplorer Ultrasound System for Evaluation of the Prostate
This clinical trial studies an ultrasound-based imaging procedure called elastography using the Aixplorer system in diagnosing prostate cancer in patients undergoing biopsy. Ultrasound is a non-invasive imaging technique that uses high-frequency sound waves to produce images of internal structures. Elastography uses ultrasound imaging techniques to examine the stiffness or elasticity of a tissue and may enhance the detection of prostate cancer. It is not yet known whether elastography imaging using the Aixplorer system works better than standard ultrasound imaging in detecting prostate cancer.
Read the detailed description
PRIMARY OBJECTIVES:
- To evaluate the detection of prostate cancer with elastography using the Aixplorer scanner.
SECONDARY OBJECTIVES:
- To obtain quantitative data on the elastic properties of normal and malignant tissue in the prostate of patients referred for ultrasound guided biopsy.
II. To compare the Gleason grade of prostate cancers detected with elastography to the Gleason grade of tumors detected by conventional systematic biopsy.
- Conditions
- Prostate Carcinoma
- Being tested
- Shear Wave Elastography, Ultrasound Elasticity Imaging, 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.
Shear Wave ElastographyProcedure or surgery
Also called Transient Elastography
Undergo ultrasound-based elastography imaging using the Aixplorer system
Ultrasound Elasticity ImagingProcedure or surgery
Undergo ultrasound-based elastography imaging using the Aixplorer system
Ultrasound-Guided Prostate BiopsyProcedure or surgery
Undergo standard of care ultrasound-guided prostate biopsy
| Study group | Role | What they receive |
|---|---|---|
| Diagnostic (elastography imaging using the Aixplorer system) | Experimental | Patients undergo ultrasound-based elastography imaging using the Aixplorer system followed by standard of care ultrasound-guided prostate biopsy over approximately 25 minutes. Receives: Procedure: Shear Wave Elastography; Procedure: Ultrasound Elasticity Imaging; Procedure: Ultrasound-Guided Prostate Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of diagnosis of prostate cancer using elastography using the Aixplorer scanner
Will focus on comparing the frequency of diagnosis of prostate cancer between conventional systematic biopsy and targeted biopsy based upon abnormalities in gray scale imaging, Doppler imaging, and elastography. The main parameter of interest will be the ratio of the detection frequency with targeted biopsy versus that with systematic biopsy. The analyses will be based on methods for matched data in cohort studies and will use the appropriate estimate and variance for the relative risk.
Measured: At the time of prostate biopsy
Secondary outcomes (1)
Gleason scores of the cores detected with targeted biopsy versus those of the cores of systematic biopsy
Analyses will be carried out via the Generalized Estimating Equations methods to account for clustering within patient (multiple cores per patient).
Measured: At the time of prostate biopsy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jan 2017 (estimated)
- Study startSep 2011
- Primary completionMay 2014
- Study completionMay 2014
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.
- 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
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ethan Halpern, MD, Principal investigator, Thomas Jefferson University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03013413
- Sponsor's protocol ID
- 11D.349
- Other IDs
- JT 1614
- Status last verified
- May 2025
- First submitted
- 4 Jan 2017
- Last updated
- 2 May 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Aixplorer Ultrasound System for Evaluation of the Prostate
- ClinicalTrials.gov ID
- NCT03013413
- Acronym / sponsor ID
- 11D.349
- Conditions
- Prostate Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 6 Jan 2017 (estimated)
- 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 clinical trial studies an ultrasound-based imaging procedure called elastography using the Aixplorer system in diagnosing prostate cancer in patients undergoing biopsy. Ultrasound is a non-invasive imaging technique that uses high-frequency sound waves to produce images of internal structures. Elastography uses ultrasound imaging techniques to examine the stiffness or elasticity of a tissue and may enhance the detection of prostate cancer. It is not yet known whether elastography imaging using the Aixplorer system works better than standard ultrasound imaging in detecting prostate cancer.
Detailed description
PRIMARY OBJECTIVES:
- To evaluate the detection of prostate cancer with elastography using the Aixplorer scanner.
SECONDARY OBJECTIVES:
- To obtain quantitative data on the elastic properties of normal and malignant tissue in the prostate of patients referred for ultrasound guided biopsy.
II. To compare the Gleason grade of prostate cancers detected with elastography to the Gleason grade of tumors detected by conventional systematic biopsy.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diagnostic (elastography imaging using the Aixplorer system) | Experimental | Procedure: Shear Wave Elastography, Procedure: Ultrasound Elasticity Imaging, Procedure: Ultrasound-Guided Prostate BiopsyPatients undergo ultrasound-based elastography imaging using the Aixplorer system followed by standard of care ultrasound-guided prostate biopsy over approximately 25 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Be scheduled for a clinically indicated biopsy of the prostate
- Agree to an ultrasound examination using the Aixplorer system
- Sign an institutional review board (IRB) approved informed consent prior to any study procedures
Key exclusion criteria (1 listed)
- Recent prostate biopsy within 90 days
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 |
|---|---|---|
| Shear Wave ElastographyAlso: Transient ElastographyUndergo ultrasound-based elastography imaging using the Aixplorer system | Procedure or surgery | Diagnostic (elastography imaging using the Aixplorer system) |
| Ultrasound Elasticity ImagingUndergo ultrasound-based elastography imaging using the Aixplorer system | Procedure or surgery | Diagnostic (elastography imaging using the Aixplorer system) |
| Ultrasound-Guided Prostate BiopsyUndergo standard of care ultrasound-guided prostate biopsy | Procedure or surgery | Diagnostic (elastography imaging using the Aixplorer system) |
Primary outcome
Frequency of diagnosis of prostate cancer using elastography using the Aixplorer scanner
Time frame: At the time of prostate biopsy
Will focus on comparing the frequency of diagnosis of prostate cancer between conventional systematic biopsy and targeted biopsy based upon abnormalities in gray scale imaging, Doppler imaging, and elastography. The main parameter of interest will be the ratio of the detection frequency with targeted biopsy versus that with systematic biopsy. The analyses will be based on methods for matched data in cohort studies and will use the appropriate estimate and variance for the relative risk.
1 secondary outcome
Gleason scores of the cores detected with targeted biopsy versus those of the cores of systematic biopsy
Time frame: At the time of prostate biopsy
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2025.
- Sidney Kimmel Cancer CenterLink provided by the sponsor.
- Thomas Jefferson University HospitalLink provided by the sponsor.
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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.
Ethan Halpern, MD principal investigator
Thomas Jefferson University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shear Wave Elastography, Ultrasound Elasticity Imaging and Ultrasound-Guided Prostate Biopsy in people with Prostate Carcinoma, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University 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 1 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 2 May 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Frequency of diagnosis of prostate cancer using elastography using the Aixplorer scanner (time frame: At the time of prostate biopsy). 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 2 May 2025.