Prostate CancerNCT00824902
Evaluation Ultrasound Elasticity/Tissue Strain-Hardening Imaging for Prostate Cancer Patients Undergoing Radical Prostatectomy
A study testing Tissue Elastography Imaging in people with Prostate Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The primary objective is to perform a pilot trial evaluation of a novel prostate ultrasound imaging software utilizing tissue elasticity measurements to identify tumor foci among men who will undergo radical prostatectomy for localized prostate cancer. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- Tissue Elastography Imaging
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2008to Nov 2013
- 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 Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients selected for radical prostatectomy (any technique) at MDACC
- Histologic diagnosis of prostate cancer, clinical stage cT1c-cT3b
- Serum prostate specific antigen less than 30 ng/ml.
- Any Gleason score
- Total prostate volume of 20-60 cc, measured by outside ultrasound or clinical examination at MDACC.
- Group 1: high volume disease. At least 3 positive cores containing cancer on one side of the prostate Group 2: low volume disease. Less than 50% tumor length in a single positive core on one side of the prostate
Who cannot join
- Prior radiation therapy to the pelvis
- Prior hormonal therapy within 3 months (including LH/RH agonists, estrogens, testosterone receptor blockade, finasteride, dutasteride)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Pilot Trial Evaluation of Ultrasound Elasticity/Tissue Strain-Hardening Imaging for Prostate Cancer in Patients Undergoing Radical Prostatectomy
The primary objective is to perform a pilot trial evaluation of a novel prostate ultrasound imaging software utilizing tissue elasticity measurements to identify tumor foci among men who will undergo radical prostatectomy for localized prostate cancer.
As a secondary objective, investigators will compare elasticity measured tumor foci volume to the measured volume from radical prostatectomy pathologic examination.
Read the detailed description
Study Imaging:
As part of routine care, ultrasound scanning is commonly used to find the cancerous areas of the prostate before the prostate is surgically removed. The ultrasound images are in black, white, and gray, and the dark areas may show prostate cancer.
In this study, standard ultrasound scanning will still be done, but researchers want to test another form of diagnostic imaging called tissue elastography.
Tissue elastography uses the same machine and probe as the ultrasound. The probe is gently pushed through the rectum and into the prostate gland (similar to a digital rectal exam). The ultrasound machine will use a special elastography software that is designed to scan the prostate for differences in how hard the tissue is. Prostate cancer tissue may be harder than surrounding tissue, and the images produced by tissue elastography are designed to show these differences in hardness of tissue.
Screening:
Before you can join this study, the study staff will review the results of your most recent prostate ultrasound and biopsy. This is a "screening" procedure to help the doctor decide if you are eligible to take part in this study.
Study Procedures:
If you are found to be eligible to take part in this study, tissue elastography imaging will be performed during your routine ultrasound before prostate surgery. The probe, once inserted, will be gently pressed against the prostate a few times in order to perform the tissue elastography. The routine ultrasound part of the procedure should take about 10 minutes, and the elastography should take about 10-15 minutes.
Length of Study Participation:
Your active participation in this study will be over after the tissue elastography imaging. The routine ultrasound will be the main decision-making exam. However, if the tissue elastography imaging shows something different and possibly related to your care, your doctor will be informed.
After the prostate is removed and the tissue results are available, researchers will compare the tissue results with the tissue elastography images. You will not receive the results of the tissue elastography imaging, as the imaging is being used for research only.
This is an investigational study. The ultrasound machine and probe that are used for the tissue elastography in this study are FDA approved for ultrasound scanning. Performing tissue elastography for prostate cancer detection is investigational. At this time and for this purpose, tissue elastography is only being performed in research.
Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson.
- Conditions
- Prostate Cancer
- Being tested
- Tissue Elastography Imaging
- Keywords
- Prostate Cancer, Prostate, Radical Prostatectomy, Tissue Elastography, Tissue Elastography Imaging, Software Program Measuring Prostate Elasticity, Elasticity/Tissue Strain-Hardening Imaging, 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.
Tissue Elastography ImagingProcedure or surgery
Using special elastography software, probe pressed gently against prostate during routine ultrasound before prostate surgery, 10-15 minutes process.
| Study group | Role | What they receive |
|---|---|---|
| Tissue Elastography Imaging | Experimental | Using special elastography software, probe pressed gently against prostate during routine ultrasound before prostate surgery, 10-15 minutes process. Receives: Procedure: Tissue Elastography Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of diagnostic technique (using tissue elastography) for prostate cancer detection in men scheduled to undergo a radical prostatectomy
Pilot evaluation of novel prostate ultrasound imaging software utilizing tissue elasticity measurements to identify tumor foci among men who will undergo radical prostatectomy for localized prostate cancer. The methods of Bland and Altman (1986) used to assess whether the tumor volume estimated by the ultrasound imaging technique agrees with the tumor volume measured at pathology. An ultrasound based elasticity measurement technique will detect differences in prostate hardness by using sophisticated mathematical techniques to analyze ultrasound images obtained before and after small compressions of the prostate gland with the ultrasound probe, detecting differences in hardness by measuring relative displacements of portions of the gland. Elasticity images obtained during standard, medically-indicated prostate sonography.
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2009 (estimated)
- Study startDec 2008
- Primary completionNov 2013
- Study completionNov 2013
Why it stopped: Technical Issues
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- John W. Davis, MD, Principal investigator, UT MD Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00824902
- Sponsor's protocol ID
- 2007-0949
- Status last verified
- Dec 2013
- First submitted
- 15 Jan 2009
- Last updated
- 9 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Trial Evaluation of Ultrasound Elasticity/Tissue Strain-Hardening Imaging for Prostate Cancer in Patients Undergoing Radical Prostatectomy
- ClinicalTrials.gov ID
- NCT00824902
- Acronym / sponsor ID
- 2007-0949
- Conditions
- Prostate Cancer
- Keywords
- Prostate Cancer, Prostate, Radical Prostatectomy, Tissue Elastography, Tissue Elastography Imaging, Software Program Measuring Prostate Elasticity, Elasticity/Tissue Strain-Hardening Imaging, Ultrasound
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Technical Issues
- Enrolment
- 13 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Dec 2008
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 19 Jan 2009 (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.
The primary objective is to perform a pilot trial evaluation of a novel prostate ultrasound imaging software utilizing tissue elasticity measurements to identify tumor foci among men who will undergo radical prostatectomy for localized prostate cancer.
As a secondary objective, investigators will compare elasticity measured tumor foci volume to the measured volume from radical prostatectomy pathologic examination.
Detailed description
Study Imaging:
As part of routine care, ultrasound scanning is commonly used to find the cancerous areas of the prostate before the prostate is surgically removed. The ultrasound images are in black, white, and gray, and the dark areas may show prostate cancer.
In this study, standard ultrasound scanning will still be done, but researchers want to test another form of diagnostic imaging called tissue elastography.
Tissue elastography uses the same machine and probe as the ultrasound. The probe is gently pushed through the rectum and into the prostate gland (similar to a digital rectal exam). The ultrasound machine will use a special elastography software that is designed to scan the prostate for differences in how hard the tissue is. Prostate cancer tissue may be harder than surrounding tissue, and the images produced by tissue elastography are designed to show these differences in hardness of tissue.
Screening:
Before you can join this study, the study staff will review the results of your most recent prostate ultrasound and biopsy. This is a "screening" procedure to help the doctor decide if you are eligible to take part in this study.
Study Procedures:
If you are found to be eligible to take part in this study, tissue elastography imaging will be performed during your routine ultrasound before prostate surgery. The probe, once inserted, will be gently pressed against the prostate a few times in order to perform the tissue elastography. The routine ultrasound part of the procedure should take about 10 minutes, and the elastography should take about 10-15 minutes.
Length of Study Participation:
Your active participation in this study will be over after the tissue elastography imaging. The routine ultrasound will be the main decision-making exam. However, if the tissue elastography imaging shows something different and possibly related to your care, your doctor will be informed.
After the prostate is removed and the tissue results are available, researchers will compare the tissue results with the tissue elastography images. You will not receive the results of the tissue elastography imaging, as the imaging is being used for research only.
This is an investigational study. The ultrasound machine and probe that are used for the tissue elastography in this study are FDA approved for ultrasound scanning. Performing tissue elastography for prostate cancer detection is investigational. At this time and for this purpose, tissue elastography is only being performed in research.
Up to 60 patients will take part in this study. All will be enrolled at M. D. Anderson.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tissue Elastography Imaging | Experimental | Procedure: Tissue Elastography ImagingUsing special elastography software, probe pressed gently against prostate during routine ultrasound before prostate surgery, 10-15 minutes process. |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- Patients selected for radical prostatectomy (any technique) at MDACC
- Histologic diagnosis of prostate cancer, clinical stage cT1c-cT3b
- Serum prostate specific antigen less than 30 ng/ml.
- Any Gleason score
- Total prostate volume of 20-60 cc, measured by outside ultrasound or clinical examination at MDACC.
Key exclusion criteria (2 listed)
- Prior radiation therapy to the pelvis
- Prior hormonal therapy within 3 months (including LH/RH agonists, estrogens, testosterone receptor blockade, finasteride, dutasteride)
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 |
|---|---|---|
| Tissue Elastography ImagingUsing special elastography software, probe pressed gently against prostate during routine ultrasound before prostate surgery, 10-15 minutes process. | Procedure or surgery | Tissue Elastography Imaging |
Primary outcome
Evaluation of diagnostic technique (using tissue elastography) for prostate cancer detection in men scheduled to undergo a radical prostatectomy
Time frame: 2 Years
Pilot evaluation of novel prostate ultrasound imaging software utilizing tissue elasticity measurements to identify tumor foci among men who will undergo radical prostatectomy for localized prostate cancer. The methods of Bland and Altman (1986) used to assess whether the tumor volume estimated by the ultrasound imaging technique agrees with the tumor volume measured at pathology. An ultrasound based elasticity measurement technique will detect differences in prostate hardness by using sophisticated mathematical techniques to analyze ultrasound images obtained before and after small compressions of the prostate gland with the ultrasound probe, detecting differences in hardness by measuring relative displacements of portions of the gland. Elasticity images obtained during standard, medically-indicated prostate sonography.
Results and safety
The study was stopped early (reason given: Technical Issues). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2015.
- UT MD Anderson Cancer Center websiteLink 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.
John W. Davis, MD principal investigator
UT MD Anderson 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 Tissue Elastography Imaging in people with Prostate Cancer, run by M.D. Anderson 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 6 inclusion and 2 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 9 Jan 2015. 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 was stopped early (reason given: Technical Issues). Results are not available in the source record.
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?
Evaluation of diagnostic technique (using tissue elastography) for prostate cancer detection in men scheduled to undergo a radical prostatectomy (time frame: 2 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 9 Jan 2015.