Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
12 participants
OBSERVATIONAL
2008-09-30
2009-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Observation of transponder stability
Observation of transponder stability and placement in the prostatic bed following radical prostatectomy
Interventions
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Observation of transponder stability
Observation of transponder stability and placement in the prostatic bed following radical prostatectomy
Eligibility Criteria
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Inclusion Criteria
2. Patients with initially undetectable PSA following prostatectomy for prostate adenocarcinoma with subsequent PSA relapse
3. Patients being planned for radiation therapy
4. Patient is being planned for implant with Calypso Transponders in the prostate bed
5. No evidence of distant metastases
6. Age ≥ 18 years
7. Informed consent
Exclusion Criteria
2. The patient has previously been implanted with permanent beacon transponders
3. The patient has a prosthetic implant in the pelvic region that contain metal or conductive materials
4. The patient has any other medical or other condition that would, in the investigator's opinion, make them a poor candidate for the study
18 Years
MALE
No
Sponsors
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Varian, a Siemens Healthineers Company
INDUSTRY
Responsible Party
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Principal Investigators
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Rajanish Singla, MD
Role: PRINCIPAL_INVESTIGATOR
Metro Uro-Rad
Locations
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21C Oncology - Scottsdale
Scottsdale, Arizona, United States
Metropolitan Uro-Rad
St Louis, Missouri, United States
Countries
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References
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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.
Other Identifiers
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CMT-07-08
Identifier Type: -
Identifier Source: org_study_id
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