Prostate CancerNCT01748890
A Pilot Trial of Sonoelastography for Planning Tumor-targeted Prostate Biopsy
A study testing Sonoelastography in people with Prostate Cancer, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
Prostate cancer is the most common cancer and the second-leading cause of cancer death amongst men in the United States. Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Sonoelastography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Dec 2012
- 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 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years of age or older.
- Serum PSA between 4 and 10 ng/mL.
- A diagnosis of prostate cancer based on extended (twelve core) random prostate biopsy within three months prior to study entry.
- Clinically localized prostate carcinoma i.e. TNM stage T2c or less.
- The patient has elected to undergo radical prostatectomy to treat the prostate carcinoma.
- The patient consents to undergo a diagnostic transrectal ultrasound of the prostate with elastography.
Who cannot join
- 1. Any contraindication to transrectal ultrasonography, including prior anorectal surgery, inflammatory bowel disease, rectal fistula, or fissure-in-ano.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Prostate cancer is the most common cancer and the second-leading cause of cancer death amongst men in the United States. Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness. It permits measurement of the elastic properties of tissue. These measurements can be transposed onto conventional anatomic ultrasound images, producing a colorized overlay that allows direct visualization of the anatomic distribution of tissue stiffness. In this study, we aim to determine whether prostate biopsies planned with sonoelastographic guidance would be more likely than random prostate biopsies to intersect with foci of carcinoma in the prostate gland, and to determine whether prostate biopsies planned with sonoelastographic guidance would be more likely than random prostate biopsies to yield histopathology representative of the final Gleason Score obtained at pathologic assessment of the resected prostate.
Read the detailed description
Background and Significance Prostate cancer is the most common cancer and the second-leading cause of cancer death amongst men in the United States. Initially, tumors biopsy guided by detected by conventional B-mode transrectal ultrasound (TRUS). Unfortunately, prostate cancer had a highly variable ultrasound echo pattern and may be indistinguishable from normal prostate, and the sonographic appearance of BPH overlaps with that of prostatic carcinoma, which limited the accuracy of conventional ultrasound, producing sensitivity and specificity for prostate carcinoma of only 40-50%. There is therefore an urgent need for better localization and more accurate biopsy of prostate cancer.
Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness. It permits measurement of the elastic properties of tissue. These measurements can be transposed onto conventional anatomic ultrasound images, producing a colorized overlay that allows direct visualization of the anatomic distribution of tissue stiffness.
Previously, several studies have reported that the feasibility of sonoelastography to distinguish between benign and malignant nodules and thereby guide biopsy. These assessments were based on the change in anatomic appearance of nodules after compression with a transrectal ultrasound probe. However, these reports did not specify the criteria used to determine that lesions seen by elastography were the same lesions seen by histopathology, did not assess whether biopsies planned with the assistance of sonoelastography would have intersected with the foci of prostate cancer, and did not address the histopathologic characteristics of areas of the prostate that were falsely positive at sonoelastography.
If sonoelastography were to more accurately delineate foci of tumor in the prostate than B mode ultrasound, and it could be used to guide biopsy, then there would be fewer missed cancers at biopsy. In addition, sonoelastography-guided biopsies may be more representative of the ultimate Gleason Score of the tumor.
Specific Aims:
Aim 1: To determine whether prostate biopsies planned with sonoelastographic guidance would be more likely than random prostate biopsies to intersect with foci of carcinoma in the prostate gland.
Aim 2: To determine whether prostate biopsies planned with sonoelastographic guidance would be more likely than random prostate biopsies to yield histopathology representative of the final Gleason Score obtained at pathologic assessment of the resected prostate.
- Conditions
- Prostate Cancer
- Being tested
- Sonoelastography
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SonoelastographyDevice
Also called Hitachi, HI VISION Preirus
Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness.
| Study group | Role | What they receive |
|---|---|---|
| Sonoelastography | Experimental | Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness. Receives: Device: Sonoelastography |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Number of Core Biopsies in These Targeted Regions
From elastography-prostatectomy pathology correlation, the following data will be obtained, 1) The number of planned core biopsies that would intersect foci of prostate carcinoma, 2) The Gleason Score that would be obtained, assuming that elastographically targeted biopsies sample the targeted region.
Measured: Participants will be followed until prostatectomy pathology is available (average 1 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2012 (estimated)
- Study startDec 2009
- Primary completionDec 2012
- Study completionDec 2012
Why it stopped: Insufficient recruitment
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.
- More trials run by Massachusetts General HospitalThe 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
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anthony Samir, Massachusetts General Hospital
- Investigators
- Anthony E. Samir, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01748890
- Sponsor's protocol ID
- 09-395
- Status last verified
- Oct 2017
- First submitted
- 31 Oct 2012
- Last updated
- 20 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial of Sonoelastography for Planning Tumor-targeted Prostate Biopsy
- ClinicalTrials.gov ID
- NCT01748890
- Acronym / sponsor ID
- 09-395
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient recruitment
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 13 Dec 2012 (estimated)
- Results
- Posted 20 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prostate cancer is the most common cancer and the second-leading cause of cancer death amongst men in the United States. Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness. It permits measurement of the elastic properties of tissue. These measurements can be transposed onto conventional anatomic ultrasound images, producing a colorized overlay that allows direct visualization of the anatomic distribution of tissue stiffness. In this study, we aim to determine whether prostate biopsies planned with sonoelastographic guidance would be more likely than random prostate biopsies to intersect with foci of carcinoma in the prostate gland, and to determine whether prostate biopsies planned with sonoelastographic guidance would be more likely than random prostate biopsies to yield histopathology representative of the final Gleason Score obtained at pathologic assessment of the resected prostate.
Detailed description
Background and Significance Prostate cancer is the most common cancer and the second-leading cause of cancer death amongst men in the United States. Initially, tumors biopsy guided by detected by conventional B-mode transrectal ultrasound (TRUS). Unfortunately, prostate cancer had a highly variable ultrasound echo pattern and may be indistinguishable from normal prostate, and the sonographic appearance of BPH overlaps with that of prostatic carcinoma, which limited the accuracy of conventional ultrasound, producing sensitivity and specificity for prostate carcinoma of only 40-50%. There is therefore an urgent need for better localization and more accurate biopsy of prostate cancer.
Sonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness. It permits measurement of the elastic properties of tissue. These measurements can be transposed onto conventional anatomic ultrasound images, producing a colorized overlay that allows direct visualization of the anatomic distribution of tissue stiffness.
Previously, several studies have reported that the feasibility of sonoelastography to distinguish between benign and malignant nodules and thereby guide biopsy. These assessments were based on the change in anatomic appearance of nodules after compression with a transrectal ultrasound probe. However, these reports did not specify the criteria used to determine that lesions seen by elastography were the same lesions seen by histopathology, did not assess whether biopsies planned with the assistance of sonoelastography would have intersected with the foci of prostate cancer, and did not address the histopathologic characteristics of areas of the prostate that were falsely positive at sonoelastography.
If sonoelastography were to more accurately delineate foci of tumor in the prostate than B mode ultrasound, and it could be used to guide biopsy, then there would be fewer missed cancers at biopsy. In addition, sonoelastography-guided biopsies may be more representative of the ultimate Gleason Score of the tumor.
Specific Aims:
Aim 1: To determine whether prostate biopsies planned with sonoelastographic guidance would be more likely than random prostate biopsies to intersect with foci of carcinoma in the prostate gland.
Aim 2: To determine whether prostate biopsies planned with sonoelastographic guidance would be more likely than random prostate biopsies to yield histopathology representative of the final Gleason Score obtained at pathologic assessment of the resected prostate.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sonoelastography | Experimental | Device: SonoelastographySonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years of age or older.
- Serum PSA between 4 and 10 ng/mL.
- A diagnosis of prostate cancer based on extended (twelve core) random prostate biopsy within three months prior to study entry.
- Clinically localized prostate carcinoma i.e. TNM stage T2c or less.
- The patient has elected to undergo radical prostatectomy to treat the prostate carcinoma.
Key exclusion criteria (1 listed)
- 1. Any contraindication to transrectal ultrasonography, including prior anorectal surgery, inflammatory bowel disease, rectal fistula, or fissure-in-ano.
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 |
|---|---|---|
| SonoelastographyAlso: Hitachi, HI VISION PreirusSonoelastography is an imaging technology predicated on reproducible differences in the backscattered ultrasound signal produced by compression of tissues of varying stiffness. | Device | Sonoelastography |
Primary outcome
The Number of Core Biopsies in These Targeted Regions
Time frame: Participants will be followed until prostatectomy pathology is available (average 1 week)
From elastography-prostatectomy pathology correlation, the following data will be obtained, 1) The number of planned core biopsies that would intersect foci of prostate carcinoma, 2) The Gleason Score that would be obtained, assuming that elastographically targeted biopsies sample the targeted region.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Oct 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Anthony E. Samir, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sonoelastography in people with Prostate Cancer, run by Massachusetts General Hospital 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 6 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: stopped early, as of the sponsor's last update on 20 Oct 2017. 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 20 May 2014). 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?
The Number of Core Biopsies in These Targeted Regions (time frame: Participants will be followed until prostatectomy pathology is available (average 1 week)). 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 20 Oct 2017.