Clinical Stage T2b or Less of Prostate CancerPhase 1/2USANCT01227642
Using Ultrasound Spectrum Analysis (USA) to Guide Dose Escalated Prostate Brachytherapy
A Phase 1/2 study testing An ultrasound-based technique to identify prostate cancer, pre-implant transrectal ultrasound images and planning and ultrasound-based cancer-specific images in people with Clinical Stage T2b or Less of Prostate Cancer and Prostate Brachytherapy, run by Beth Israel Medical Center at 1 site in United States.
Trial summary
In standard treatment, the seeds are placed throughout the prostate to treat the entire prostate. This is done because it was impossible to know where the cancer was located within the prostate. A new technique has been developed using the same ultrasound imaging that you probably had when you had your biopsy. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Clinical Stage T2b or Less of Prostate Cancer, Prostate Brachytherapy, Transrectal Prostate Ultrasound Treatment Planning
- What is being tested?
- An ultrasound-based technique to identify prostate cancer, pre-implant transrectal ultrasound images and planning and ultrasound-based cancer-specific images
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Aug 2014
- Phase
- Phase 1/2
- 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
- Clinical stage ≤ T2b according to the American Joint Commission on Cancer 6th Edition28
- PSA ≤ 10 ng/ml
- Gleason sum on biopsy ≤ 6
- Prostate volume ≤ 50 cc
- Willing to continue follow-up for at least two years.
Who cannot join
- No prior hormone therapy
- No prior radiotherapy
- No history of collagen vascular disease
- No history of inflammatory bowel disease
Trial locations and contacts
1 site in 1 country.
United States1 site
St.Luke's-Roosevelt Hospital Center
New York, New York, 10019
About this study
Official title: Phase I/II Evaluation of Cancer-Specific Imaging Using Ultrasound Spectrum Analysis (USA) to Guide Dose Escalated Prostate Brachytherapy
In standard treatment, the seeds are placed throughout the prostate to treat the entire prostate. This is done because it was impossible to know where the cancer was located within the prostate. A new technique has been developed using the same ultrasound imaging that you probably had when you had your biopsy. Using this technique, areas likely to contain prostate cancer can be identified.In this early study of 15 subjects, we will test if this method to plan your prostate seed implant is safe and can be done as part of regular care. Areas identified as suspicious for cancer will be treated with higher doses of radiation while those areas not demonstrating cancer will be treated to the standard minimum dose. The higher dose areas will receive two times the minimum dose the prostate usually receives. Because this technique is not perfect, those areas not identified as cancerous should be treated in case there is a cancer area that the technique did not identify. Subjects enrolled in this study will then be followed with this ultrasound technique over the next two years to monitor the changes to the cancerous areas and will undergo a biopsy two years after the procedure. Subjects will, of course, be monitored to assess the success of the technique and its side effects.
Read the detailed description
Prostate brachytherapy is an increasingly popular treatment for clinically localized prostate cancer.In properly selected patients, it is highly effective with biochemical (PSA) disease free survival rates of 80-87% at 5-10 years.However, the technique is currently limited by the inability to localize the cancer within the prostate. The multifocal nature of prostate cancer is well established. Because of the inability to know where within the prostate the cancer is located, radiation must be delivered throughout the gland. Although this blind approach leads to good results, it is clear that there are regions of the prostate and surrounding tissue that are overexposed to radiation while others are underexposed relative to their true need based on their tumor burden and their proximity to the tumor areas.Feleppa et al. at Riverside Research Institute (New York, NY), a non-profit ultrasound research center, have developed an ultrasound-based technique to identify cancer-containing areas within the prostate. This technique uses current ultrasound equipment already in use for prostate brachytherapy guidance. By extracting and processing the radiofrequency signal obtained from the ultrasound transducer in ways not done to create the standard B-mode ultrasound image, areas of cancer can be identified and displayed overlying the standard B-mode ultrasound image.In this study, we propose to obtain these ultrasound-based cancer-specific images of the prostate prior to the brachytherapy and use them to direct the dosimetry planning.The primary goal of this study is to demonstrate that this imaging modality can be incorporated into the treatment planning process for brachytherapy. Furthermore, we wish to demonstrate the improved dosimetry of the cancer-identified regions while maintaining the urethral dose guidelines noted above. We also wish to compare the differences in dose to the other adjacent normal structures (anterior rectum and right and left neurovascular bundles). Additionally, we seek to demonstrate, at a minimum, no increased toxicity with this approach and similar disease control rates. Of course, ultimately the goal will be to demonstrate a superior therapeutic ratio with this technique.
- Conditions
- Clinical Stage T2b or Less of Prostate Cancer, Prostate Brachytherapy, Transrectal Prostate Ultrasound Treatment Planning
- Being tested
- An ultrasound-based technique to identify prostate cancer, pre-implant transrectal ultrasound images and planning, ultrasound-based cancer-specific images
- Keywords
- Prostate Cancer, Prostate brachytherapy, Ultrasound treatment planning
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
An ultrasound-based technique to identify prostate cancerOther
The technique uses current ultrasound equipment already in use for prostate brachytherapy guidance.By extracting and processing the radiofrequency signal obtained from the ultrasound transducer in ways not done to create the standard B-mode ultrasound image, areas of cancer can be identified and displayed overlying the standard B-mode ultrasound image. Comparing the results with this technique to the results of prostate biopsies demonstrates a high degree of accuracy with the area under the receiver-operator characteristic curve of 0.87, a result superior to any other imaging methods.
pre-implant transrectal ultrasound images and planningOther
an ultrasound-based technique to identify cancer-containing areas within the prostate.
ultrasound-based cancer-specific imagesOther
Also called The ultrasound unit used is the B+K Hawk 2102 with probe #8658.
ultrasound-based cancer-specific images of the prostate prior to the brachytherapy and use them to direct the dosimetry planning
| Study group | Role | What they receive |
|---|---|---|
| pre-implant transrectal ultrasound images and planning | Experimental | Transrectal ultrasound session will be performed at a separate session prior to the implant. Receives: Other: An ultrasound-based technique to identify prostate cancer; Other: pre-implant transrectal ultrasound images and planning; Other: ultrasound-based cancer-specific images |
What is being measured
The primary outcome is the main question the study is designed to answer.
modified B+K ultrasound-based tissue-type images
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 posted25 Oct 2010 (estimated)
- Study startFeb 2007
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Clinical Stage T2b or Less of 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beth Israel Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Riverside Research Institute
- Responsible party
- Sponsor
- Investigators
- Ronald Ennis, MD, Principal investigator, St. Luke's-Roosevelt Hospital Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01227642
- Sponsor's protocol ID
- 06-147
- Acronym
- USA
- Status last verified
- Mar 2016
- First submitted
- 22 Oct 2010
- Last updated
- 14 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ennis RD, Quinn SA, Trichter F, Ryemon S, Jain A, Saigal K, Chandrashekhar S, Romas NA, Feleppa EJ. Phase I/II prospective trial of cancer-specific imaging using ultrasound spectrum analysis tissue-type imaging to guide dose-painting prostate brachytherapy. Brachytherapy. 2015 Nov-Dec;14(6):801-8. doi: 10.1016/j.brachy.2015.06.011. Epub 2015 Jul 31.
PubMed 26235201
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Evaluation of Cancer-Specific Imaging Using Ultrasound Spectrum Analysis (USA) to Guide Dose Escalated Prostate Brachytherapy
- ClinicalTrials.gov ID
- NCT01227642
- Acronym / sponsor ID
- USA / 06-147
- Conditions
- Clinical Stage T2b or Less of Prostate Cancer, Prostate Brachytherapy, Transrectal Prostate Ultrasound Treatment Planning
- Keywords
- Prostate Cancer, Prostate brachytherapy, Ultrasound treatment planning
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Beth Israel Medical CenterUniversity, hospital or other
- Collaborators
- Riverside Research Institute
- Study start
- Feb 2007
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 25 Oct 2010 (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.
In standard treatment, the seeds are placed throughout the prostate to treat the entire prostate. This is done because it was impossible to know where the cancer was located within the prostate. A new technique has been developed using the same ultrasound imaging that you probably had when you had your biopsy. Using this technique, areas likely to contain prostate cancer can be identified.In this early study of 15 subjects, we will test if this method to plan your prostate seed implant is safe and can be done as part of regular care. Areas identified as suspicious for cancer will be treated with higher doses of radiation while those areas not demonstrating cancer will be treated to the standard minimum dose. The higher dose areas will receive two times the minimum dose the prostate usually receives. Because this technique is not perfect, those areas not identified as cancerous should be treated in case there is a cancer area that the technique did not identify. Subjects enrolled in this study will then be followed with this ultrasound technique over the next two years to monitor the changes to the cancerous areas and will undergo a biopsy two years after the procedure. Subjects will, of course, be monitored to assess the success of the technique and its side effects.
Detailed description
Prostate brachytherapy is an increasingly popular treatment for clinically localized prostate cancer.In properly selected patients, it is highly effective with biochemical (PSA) disease free survival rates of 80-87% at 5-10 years.However, the technique is currently limited by the inability to localize the cancer within the prostate. The multifocal nature of prostate cancer is well established. Because of the inability to know where within the prostate the cancer is located, radiation must be delivered throughout the gland. Although this blind approach leads to good results, it is clear that there are regions of the prostate and surrounding tissue that are overexposed to radiation while others are underexposed relative to their true need based on their tumor burden and their proximity to the tumor areas.Feleppa et al. at Riverside Research Institute (New York, NY), a non-profit ultrasound research center, have developed an ultrasound-based technique to identify cancer-containing areas within the prostate. This technique uses current ultrasound equipment already in use for prostate brachytherapy guidance. By extracting and processing the radiofrequency signal obtained from the ultrasound transducer in ways not done to create the standard B-mode ultrasound image, areas of cancer can be identified and displayed overlying the standard B-mode ultrasound image.In this study, we propose to obtain these ultrasound-based cancer-specific images of the prostate prior to the brachytherapy and use them to direct the dosimetry planning.The primary goal of this study is to demonstrate that this imaging modality can be incorporated into the treatment planning process for brachytherapy. Furthermore, we wish to demonstrate the improved dosimetry of the cancer-identified regions while maintaining the urethral dose guidelines noted above. We also wish to compare the differences in dose to the other adjacent normal structures (anterior rectum and right and left neurovascular bundles). Additionally, we seek to demonstrate, at a minimum, no increased toxicity with this approach and similar disease control rates. Of course, ultimately the goal will be to demonstrate a superior therapeutic ratio with this technique.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pre-implant transrectal ultrasound images and planning | Experimental | Other: An ultrasound-based technique to identify prostate cancer, Other: pre-implant transrectal ultrasound images and planning, Other: ultrasound-based cancer-specific imagesTransrectal ultrasound session will be performed at a separate session prior to the implant. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Clinical stage ≤ T2b according to the American Joint Commission on Cancer 6th Edition28
- PSA ≤ 10 ng/ml
- Gleason sum on biopsy ≤ 6
- Prostate volume ≤ 50 cc
- Willing to continue follow-up for at least two years.
Key exclusion criteria (4 listed)
- No prior hormone therapy
- No prior radiotherapy
- No history of collagen vascular disease
- No history of inflammatory bowel disease
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 |
|---|---|---|
| An ultrasound-based technique to identify prostate cancerThe technique uses current ultrasound equipment already in use for prostate brachytherapy guidance.By extracting and processing the radiofrequency signal obtained from the ultrasound transducer in ways not done to create the standard B-mode ultrasound image, areas of cancer can be identified and displayed overlying the standard B-mode ultrasound image. Comparing the results with this technique to the results of prostate biopsies demonstrates a high degree of accuracy with the area under the receiver-operator characteristic curve of 0.87, a result superior to any other imaging methods. | Other | pre-implant transrectal ultrasound images and planning |
| pre-implant transrectal ultrasound images and planningan ultrasound-based technique to identify cancer-containing areas within the prostate. | Other | pre-implant transrectal ultrasound images and planning |
| ultrasound-based cancer-specific imagesAlso: The ultrasound unit used is the B+K Hawk 2102 with probe #8658.ultrasound-based cancer-specific images of the prostate prior to the brachytherapy and use them to direct the dosimetry planning | Other | pre-implant transrectal ultrasound images and planning |
Primary outcome
modified B+K ultrasound-based tissue-type images
Time frame: 2 years
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 14 Mar 2016.
- Results publication: PubMed 26235201Ennis RD, Quinn SA, Trichter F, Ryemon S, Jain A, Saigal K, Chandrashekhar S, Romas NA, Feleppa EJ. Phase I/II prospective trial of cancer-specific imaging using ultrasound spectrum analysis tissue-type imaging to guide dose-painting prostate brachytherapy. Brachytherapy. 2015 Nov-Dec;14(6):801-8. doi: 10.1016/j.brachy.2015.06.011. Epub 2015 Jul 31.
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.
Ronald Ennis, MD principal investigator
St. Luke's-Roosevelt Hospital Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing An ultrasound-based technique to identify prostate cancer, pre-implant transrectal ultrasound images and planning and ultrasound-based cancer-specific images in people with Clinical Stage T2b or Less of Prostate Cancer and Prostate Brachytherapy, run by Beth Israel Medical 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 5 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: finished, as of the sponsor's last update on 14 Mar 2016. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
modified B+K ultrasound-based tissue-type images (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01227642, which also lists 1 linked publication.
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 14 Mar 2016.