CMT-07-08: The PROstate Bed Evaluation Study
October 13, 2015 updated by: Varian, a Siemens Healthineers Company
The Probe Study - The PROstate Bed Evaluation - A Study to Record the Implant Experience, Transponder Stability and Tracking Data of the Calypso 4D Localization Study in the Prostate Bed
This is an observational study to collect placement and tracking data for patients who have the Calypso transponders implanted into the peri-prostatic tissue.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Use of Real-time tracking using Calypso Electromagnetic Beacons in the prostatic bed of patients receiving radiotherapy following radical prostatectomy.
Study Type
Observational
Enrollment (Actual)
12
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Scottsdale, Arizona, United States, 85251
- 21C Oncology - Scottsdale
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Missouri
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St. Louis, Missouri, United States, 63141
- Metropolitan Uro-Rad
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Non-Probability Sample
Study Population
Patients with cancer of the peri-prostatic tissue or prostate bed
Description
Inclusion Criteria:
- Patients with recurrence of prostate cancer following radical prostatectomy for prostate adenocarcinoma
- Patients with initially undetectable PSA following prostatectomy for prostate adenocarcinoma with subsequent PSA relapse
- Patients being planned for radiation therapy
- Patient is being planned for implant with Calypso Transponders in the prostate bed
- No evidence of distant metastases
- Age ≥ 18 years
- Informed consent
Exclusion Criteria:
- The patient has received other investigational therapy in the last 60 days
- The patient has previously been implanted with permanent beacon transponders
- The patient has a prosthetic implant in the pelvic region that contain metal or conductive materials
- The patient has any other medical or other condition that would, in the investigator's opinion, make them a poor candidate for the study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
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stability of Beacons in prostatic bed
Patients implanted with the Calypso transponders following radical prostatectomy for prostate cancer will be followed for observation of transponder stability.
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Observation of transponder stability and placement in the prostatic bed following radical prostatectomy
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
To collect data on the process of implanting the Calypso Transponder in the prostate bed following radical prostatectomy
Time Frame: Immediate
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Immediate
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Evaluate the stability of the Calypso transponder in the prostate bed
Time Frame: 60 days
|
60 days
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Rajanish Singla, MD, Metro Uro-Rad
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Balter JM, Wright JN, Newell LJ, Friemel B, Dimmer S, Cheng Y, Wong J, Vertatschitsch E, Mate TP. Accuracy of a wireless localization system for radiotherapy. Int J Radiat Oncol Biol Phys. 2005 Mar 1;61(3):933-7. doi: 10.1016/j.ijrobp.2004.11.009.
- Litzenberg DW, Willoughby TR, Balter JM, Sandler HM, Wei J, Kupelian PA, Cunningham AA, Bock A, Aubin M, Roach M 3rd, Shinohara K, Pouliot J. Positional stability of electromagnetic transponders used for prostate localization and continuous, real-time tracking. Int J Radiat Oncol Biol Phys. 2007 Jul 15;68(4):1199-206. doi: 10.1016/j.ijrobp.2007.03.030. Epub 2007 May 21.
- Kupelian P, Willoughby T, Mahadevan A, Djemil T, Weinstein G, Jani S, Enke C, Solberg T, Flores N, Liu D, Beyer D, Levine L. Multi-institutional clinical experience with the Calypso System in localization and continuous, real-time monitoring of the prostate gland during external radiotherapy. Int J Radiat Oncol Biol Phys. 2007 Mar 15;67(4):1088-98. doi: 10.1016/j.ijrobp.2006.10.026. Epub 2006 Dec 21.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2008
Primary Completion (Actual)
August 1, 2009
Study Completion (Actual)
August 1, 2009
Study Registration Dates
First Submitted
September 25, 2008
First Submitted That Met QC Criteria
September 26, 2008
First Posted (Estimate)
September 30, 2008
Study Record Updates
Last Update Posted (Estimate)
October 15, 2015
Last Update Submitted That Met QC Criteria
October 13, 2015
Last Verified
October 1, 2015
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMT-07-08
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.