Status:
COMPLETED
CMT-07-08: The PROstate Bed Evaluation Study
Lead Sponsor:
Varian, a Siemens Healthineers Company
Conditions:
Prostate Cancer
Eligibility:
MALE
18+ years
Brief Summary
This is an observational study to collect placement and tracking data for patients who have the Calypso transponders implanted into the peri-prostatic tissue.
Detailed Description
Use of Real-time tracking using Calypso Electromagnetic Beacons in the prostatic bed of patients receiving radiotherapy following radical prostatectomy.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
September 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2009
Estimated Enrollment :
12 Patients enrolled
Trial Details
Trial ID
NCT00763152
Start Date
September 1 2008
End Date
August 1 2009
Last Update
October 15 2015
Active Locations (2)
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1
21C Oncology - Scottsdale
Scottsdale, Arizona, United States, 85251
2
Metropolitan Uro-Rad
St Louis, Missouri, United States, 63141