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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prostate cancer, post-prostatectomy |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transperineal Ultrasound | Device |
|
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | One measurement will be done at the time of the initial simulation. The participants will then have 8 weeks of standard external beam radiation. |
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Inclusion Criteria:
Exclusion Criteria:
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University of Vermont Medical Center- Radiation Oncology Patient Prostate cancer w/ prostatectomy
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| Name | Affiliation | Role |
|---|---|---|
| James Wallace, MD | Fletcher Allen Healthcare | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Radiation Oncology, Fletcher Allen Healthcare | Burlington | Vermont | 05401 | United States |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |