CMT-07-08: The PROstate Bed Evaluation Study

Prostate Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00763152
• Other study ID #: CMT-07-08
• Status: Completed
• Phase: N/A
• First received: September 25, 2008
• Last updated: October 13, 2015
• Start date: September 2008
• Est. completion date: August 2009

Study information

• Verified date: October 2015
• Source: Varian Medical
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Description:

Use of Real-time tracking using Calypso Electromagnetic Beacons in the prostatic bed of patients receiving radiotherapy following radical prostatectomy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: August 2009
• Est. primary completion date: August 2009
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Prostate Cancer

Intervention

Other:
• Observation of transponder stability
Observation of transponder stability and placement in the prostatic bed following radical prostatectomy

Locations

Country	Name	City	State
United States	21C Oncology - Scottsdale	Scottsdale	Arizona
United States	Metropolitan Uro-Rad	St. Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Varian Medical

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View 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. Epub 2006 Dec 21. — View 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. Epub 2007 May 21. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To collect data on the process of implanting the Calypso Transponder in the prostate bed following radical prostatectomy		Immediate	No
Secondary	Evaluate the stability of the Calypso transponder in the prostate bed		60 days	No