- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01545154
The Use of Transperineal Ultrasound for Radiation Therapy Treatment Planning and Image Guidance in the Treatment of Prostate Cancer
Phase II Study of The Use of Transperineal Ultrasound for Radiation Therapy Treatment Planning and Image Guidance in the Treatment of Prostate Cancer
This study is being done to find out if transperineal ultrasound (TPUS) can help define the prostate gland 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 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. The investigators completed an earlier study and have developed a TPUS device and process that allow us to get clear ultrasound pictures of the prostate gland. The TPUS has three potential advantages over the transabdominal method the investigators 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 gland. 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 gland 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 gland during treatment. If the investigators discover that they can accurately view the prostate gland 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 techniques used at Fletcher Allen Health Care: transabdominal ultrasound and/or X-ray imaging of gold marker seeds that have been placed the prostate gland. In addition to standard care, all men in this study will have TPUS and CT scans done a total of four times over 12 weeks to compare these methods of prostate localization over the course of radiation treatments. Some men may choose to take part in an additional study that will also include MRI of the pelvis to compare with the TPUS and CT. Because the prostate gland can be more clearly defined on MRI, some institutions (not Fletcher Allen) routinely have patients with prostate cancer get MRI scans for treatment planning. This has not been proven to improve the care of men with prostate cancer and it is possible that TPUS will provide similarly clear images. The potential advantages to TPUS imaging for prostate localization over MRI include the fact that it is done at the same time as the CT for treatment planning (so eliminates the possibility of movement of the prostate gland from the time of the MRI to the time of the CT) and can be done at a much lower cost.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Vermont
-
Burlington, Vermont, United States, 05401
- Fletcher Allen Health Care
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Clinical diagnosis of prostate cancer
Exclusion Criteria:
- Prostatectomy
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Prostate Cancer
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ESTIMATE)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHRMS M12-073
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Prostate Cancer
-
Roswell Park Cancer InstituteRecruitingObesity | Overweight | Cancer Survivor | Prostate Adenocarcinoma | Stage I Prostate Cancer | Stage II Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate Cancer | Stage IVA Prostate Cancer | Stage IVB Prostate Cancer | Stage A Prostate Cancer | Stage... and other conditionsUnited States
-
Sidney Kimmel Cancer Center at Thomas Jefferson...Regeneron Pharmaceuticals; Prostate Cancer FoundationWithdrawnStage III Prostate Cancer | Stage IV Prostate Cancer | Stage IVA Prostate Cancer | Stage IVB Prostate Cancer | Stage IIIA Prostate Cancer | Stage IIIB Prostate Cancer | Stage IIIC Prostate Cancer
-
Jonsson Comprehensive Cancer CenterNational Cancer Institute (NCI)CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Ryan Kohlbrenner, MDRadiological Society of North AmericaCompletedProstate Adenocarcinoma | Stage IV Prostate Cancer AJCC v8 | Prostate Carcinoma | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IVA Prostate Cancer AJCC v8 | Stage...United States
-
University of Southern CaliforniaNational Cancer Institute (NCI); SanofiTerminatedDiarrhea | Recurrent Prostate Cancer | Hormone-resistant Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Jonsson Comprehensive Cancer CenterProgenics Pharmaceuticals, Inc.TerminatedRandomized Trial of PSMA PET Scan Before Definitive Radiation Therapy for Prostate Cancer (PSMA-dRT)Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IIA Prostate Cancer AJCC v8 | Stage IIB Prostate Cancer AJCC v8 | Stage I Prostate...United States
-
Ohio State University Comprehensive Cancer CenterRiverside Methodist HospitalCompletedStage I Prostate Cancer | Stage III Prostate Cancer | Stage IV Prostate Cancer | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
University of California, IrvineCompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
-
Mayo ClinicNational Cancer Institute (NCI)WithdrawnStage I Prostate Cancer AJCC v8 | Stage II Prostate Cancer AJCC v8 | Stage IIIA Prostate Cancer AJCC v8 | Stage IIIB Prostate Cancer AJCC v8 | Stage IIC Prostate Cancer AJCC v8 | Stage III Prostate Cancer AJCC v8 | Stage IIIC Prostate Cancer AJCC v8 | Stage IIA Prostate Cancer AJCC v8 | Stage IIB Prostate...United States
-
Barbara Ann Karmanos Cancer InstituteGenentech, Inc.CompletedRecurrent Prostate Cancer | Stage I Prostate Cancer | Stage III Prostate Cancer | Adenocarcinoma of the Prostate | Stage IIA Prostate Cancer | Stage IIB Prostate CancerUnited States
Clinical Trials on Transperineal Ultrasound
-
Kaohsiung Medical University Chung-Ho Memorial...CompletedUrodynamic Stress Incontinence
-
Linkoeping UniversityCompletedObesity | Pregnancy
-
Bezmialem Vakif UniversityCompleted
-
St. Olavs HospitalNot yet recruitingChildbirth Problems | Pelvic Floor Dyssynergia | Pelvic Floor; RuptureNorway
-
Sanliurfa Mehmet Akif Inan Education and Research...CompletedIntrapartum Transperineal UltrasoundTurkey
-
Sehit Prof. Dr. Ilhan Varank Sancaktepe Training...Active, not recruitingProgression | Ultrasound Therapy; Complications | Labour;Obstructed | Delivery Problem for FetusTurkey
-
Kaplan Medical CenterCompletedChorioamnionitis | Fever | Pregnancy Related | Labor ComplicationIsrael
-
Cairo UniversityCompletedAnal Sphincter Tear Complicating DeliveryEgypt
-
Alexandria UniversityCompleted
-
Aljazeera HospitalKasr El Aini HospitalUnknown