Clinical trial NCT00763152: CMT-07-08: The PROstate Bed Evaluation Study
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Keywords: prostate
prostate bed
periprostatic
Lead sponsor: Varian, a Siemens Healthineers Company
Sponsor class: INDUSTRY
First posted: 2008-09-30
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with cancer of the peri-prostatic tissue or prostate bed

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 Criteria:

1. Patients with recurrence of prostate cancer following radical prostatectomy for prostate adenocarcinoma
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:

1. The patient has received other investigational therapy in the last 60 days
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

Primary outcomes:
measure: To collect data on the process of implanting the Calypso Transponder in the prostate bed following radical prostatectomy
timeFrame: Immediate
Secondary outcomes:
measure: Evaluate the stability of the Calypso transponder in the prostate bed
timeFrame: 60 days
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: 21C Oncology - Scottsdale
state: Arizona
city: St. Louis
country: United States
facility: Metropolitan Uro-Rad
state: Missouri
Study officials:
affiliation: Metro Uro-Rad
name: Rajanish Singla, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.