Prostate CancerNCT02110667
Evaluation Of Transperineal Ultrasound For Image Guidance In The Treatment Of Prostate Cancer in Men Following Prostatectomy
An observational study of Prostate Cancer and Post-Prostatectomy, run by University of Vermont Medical Center at 1 site in United States.
Trial summary
This study is being done to find out if transperineal ultrasound (TPUS) can help define the prostate bed for radiation treatment planning and improve upon current methods of image guidance for the treatment of prostate cancer. Read more about this study
- Who is it for?
- Ages 18 to 100 years, men only
- Conditions the study is for
- Prostate Cancer, Post-Prostatectomy
- What is being tested?
- Transperineal Ultrasound
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2014to 31 Dec 2016
- Phase
- Observational
- 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 to 100 years
- Men only
- No healthy volunteers
- Adult, Older adult
Study population: University of Vermont Medical Center- Radiation Oncology Patient Prostate cancer w/ prostatectomy
Who may be able to join
- Male, over age 18
- Clinical diagnosis of prostate cancer
- Post- prostatectomy surgery
- Undergoing external beam radiation
Who cannot join
- Unable to tolerate transperineal ultrasound
Trial locations and contacts
1 site in 1 country.
United States1 site
Radiation Oncology, Fletcher Allen Healthcare
Burlington, Vermont, 05401
About this study
This study is being done to find out if transperineal ultrasound (TPUS) can help define the prostate bed for radiation treatment planning and improve upon current methods of image guidance for the treatment of prostate cancer. For the patient, TPUS involves the placement of an ultrasound probe on the perineum, the skin between the scrotum and anus, while they are lying on their back in the position they will receive their treatment. Image-guidance is required for the treatment of prostate cancer because the prostate bed shifts position depending on how full the bladder and rectum are. Image-guided radiation therapy has been done at Fletcher Allen Health Care for approximately three years. Most commonly, transabdominal ultrasound images are obtained every day and compared to an ultrasound that was done on the day of treatment planning. Adjustments in radiation field position can be done on a daily basis by comparing these images. Transperineal ultrasound has never been used for image-guidance. We completed two phases of an earlier study and have developed a TPUS device and process that allow us to get clear ultrasound pictures of the prostate gland, and now we would like to explore imaging the prostate bed left after radical prostatectomy.The TPUS has three potential advantages over the transabdominal method we currently use:
- Transabdominal ultrasound can be a challenge for some men. A full bladder helps us get clearer images, however it is difficult for some men with prostate cancer to comfortably keep a full bladder. It is also particularly difficult to get good images in larger men who have long distances from the skin surface to the prostate bed. TPUS is not dependent on a man having a full bladder and should be less dependent on the size of the man.
- TPUS images and the planning CT images can be acquired simultaneously. This is not possible with the abdominal probe because it gets in the way of the CT machine. Simultaneous imaging eliminates the possibility of the prostate bed shifting positions during the time between imaging studies.
- TPUS can be in place and acquire images during patient treatment (the abdominal probe gets in the way of the treatment machine) and may in the future allow us to watch the prostate bed during treatment. If we discover that we can accurately view the prostate bed in real time, TPUS may ultimately allow us to treat even smaller radiation fields and possibly decrease the risk of radiation complications.
Read more
Patients in this study will be treated for their prostate cancer with the standard image guidance technique used at Fletcher Allen Health Care: transabdominal ultrasound. In addition, one TPUS scan will be acquired at the time of the initial simulation.
To summarize, the two objectives of this study are:
- To determine if TPUS can acquire usable, clinically pertinent IGRT images of the prostate bed.
- To preliminarily compare TPUS images of the prostate bed to images obtained with CT and TAUS.
- Conditions
- Prostate Cancer, Post-Prostatectomy
- Being tested
- Transperineal Ultrasound
- Keywords
- Prostate cancer, Prostatectomy, Ultrasound, TPUS
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transperineal UltrasoundDevice
Also called Elekta, Ltd. probe
| Study group | Role | What they receive |
|---|---|---|
| Prostate cancer, post-prostatectomy | Not described Receives: Device: Transperineal Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
The concluding outcome measure will be "number of patients with image quality equivalent to or better than CT Imaging
On Day 1, patients will be simulated with transabdominal ultrasound, and a treatment plan will be made employing this ultrasound as a reference point for the daily scans to be performed throughout treatment. A transperineal ultrasound will take place on Day 1 as well. The treatments will begin about 4 weeks later and take place daily for approximately 8 weeks. 3 times (each about 2 weeks apart) throughout the 8 weeks, an additional transperineal ultrasound will be performed as well. A radiation oncologist (HJW) will qualitatively describe and compare the visibility of the prostate bed, bladder, rectum, and penile bulb based on CT, TPUS and TAUS images. The prostate bed for the purposes of this study will be defined as the wall of the base of the bladder that extends from the most posterior edge of the pubic symphysis posteriorly 5 cm. We have adapted a previously used scoring system for the purposes of this study.
Measured: One measurement will be done at the time of the initial simulation. The participants will then have 8 weeks of standard external beam radiation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2014 (estimated)
- Study startApr 2014
- Primary completionJan 2016
- Study completion31 Dec 2016
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.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Vermont Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, H. James Wallace, MD, University of Vermont Medical Center
- Investigators
- James Wallace, MD, Principal investigator, Fletcher Allen Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02110667
- Sponsor's protocol ID
- M14-170
- Status last verified
- May 2017
- First submitted
- 27 Mar 2014
- Last updated
- 3 May 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Of Transperineal Ultrasound For Image Guidance In The Treatment Of Prostate Cancer in Men Following Prostatectomy
- ClinicalTrials.gov ID
- NCT02110667
- Acronym / sponsor ID
- M14-170
- Conditions
- Prostate Cancer, Post-Prostatectomy
- Keywords
- Prostate cancer, Prostatectomy, Ultrasound, TPUS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of Vermont Medical CenterUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Jan 2016 (actual)
- Study completion
- 31 Dec 2016 (actual)
- First posted
- 10 Apr 2014 (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 study is being done to find out if transperineal ultrasound (TPUS) can help define the prostate bed for radiation treatment planning and improve upon current methods of image guidance for the treatment of prostate cancer. For the patient, TPUS involves the placement of an ultrasound probe on the perineum, the skin between the scrotum and anus, while they are lying on their back in the position they will receive their treatment. Image-guidance is required for the treatment of prostate cancer because the prostate bed shifts position depending on how full the bladder and rectum are. Image-guided radiation therapy has been done at Fletcher Allen Health Care for approximately three years. Most commonly, transabdominal ultrasound images are obtained every day and compared to an ultrasound that was done on the day of treatment planning. Adjustments in radiation field position can be done on a daily basis by comparing these images. Transperineal ultrasound has never been used for image-guidance. We completed two phases of an earlier study and have developed a TPUS device and process that allow us to get clear ultrasound pictures of the prostate gland, and now we would like to explore imaging the prostate bed left after radical prostatectomy.The TPUS has three potential advantages over the transabdominal method we currently use:
- Transabdominal ultrasound can be a challenge for some men. A full bladder helps us get clearer images, however it is difficult for some men with prostate cancer to comfortably keep a full bladder. It is also particularly difficult to get good images in larger men who have long distances from the skin surface to the prostate bed. TPUS is not dependent on a man having a full bladder and should be less dependent on the size of the man.
- TPUS images and the planning CT images can be acquired simultaneously. This is not possible with the abdominal probe because it gets in the way of the CT machine. Simultaneous imaging eliminates the possibility of the prostate bed shifting positions during the time between imaging studies.
- TPUS can be in place and acquire images during patient treatment (the abdominal probe gets in the way of the treatment machine) and may in the future allow us to watch the prostate bed during treatment. If we discover that we can accurately view the prostate bed in real time, TPUS may ultimately allow us to treat even smaller radiation fields and possibly decrease the risk of radiation complications.
Patients in this study will be treated for their prostate cancer with the standard image guidance technique used at Fletcher Allen Health Care: transabdominal ultrasound. In addition, one TPUS scan will be acquired at the time of the initial simulation.
To summarize, the two objectives of this study are:
- To determine if TPUS can acquire usable, clinically pertinent IGRT images of the prostate bed.
- To preliminarily compare TPUS images of the prostate bed to images obtained with CT and TAUS.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prostate cancer, post-prostatectomy | – | Device: Transperineal Ultrasound |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- University of Vermont Medical Center- Radiation Oncology Patient Prostate cancer w/ prostatectomy
Key inclusion criteria (4 listed)
- Male, over age 18
- Clinical diagnosis of prostate cancer
- Post- prostatectomy surgery
- Undergoing external beam radiation
Key exclusion criteria (1 listed)
- Unable to tolerate transperineal ultrasound
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 |
|---|---|---|
| Transperineal UltrasoundAlso: Elekta, Ltd. probe | Device | Prostate cancer, post-prostatectomy |
Primary outcome
The concluding outcome measure will be "number of patients with image quality equivalent to or better than CT Imaging
Time frame: One measurement will be done at the time of the initial simulation. The participants will then have 8 weeks of standard external beam radiation.
On Day 1, patients will be simulated with transabdominal ultrasound, and a treatment plan will be made employing this ultrasound as a reference point for the daily scans to be performed throughout treatment. A transperineal ultrasound will take place on Day 1 as well. The treatments will begin about 4 weeks later and take place daily for approximately 8 weeks. 3 times (each about 2 weeks apart) throughout the 8 weeks, an additional transperineal ultrasound will be performed as well. A radiation oncologist (HJW) will qualitatively describe and compare the visibility of the prostate bed, bladder, rectum, and penile bulb based on CT, TPUS and TAUS images. The prostate bed for the purposes of this study will be defined as the wall of the base of the bladder that extends from the most posterior edge of the pubic symphysis posteriorly 5 cm. We have adapted a previously used scoring system for the purposes of this study.
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 3 May 2017.
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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.
James Wallace, MD principal investigator
Fletcher Allen Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Post-Prostatectomy, run by University of Vermont 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 4 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 3 May 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?
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?
The concluding outcome measure will be "number of patients with image quality equivalent to or better than CT Imaging (time frame: One measurement will be done at the time of the initial simulation. The participants will then have 8 weeks of standard external beam radiation.). 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 3 May 2017.