CMT-07-08: The PROstate Bed Evaluation Study - Full Text View

Sponsor:	Varian Medical
Information provided by:	Varian Medical
ClinicalTrials.gov Identifier:	NCT00763152

Purpose

This is an observational study to collect placement and tracking data for patients who have the Calypso transponders implanted into the peri-prostatic tissue.

Condition	Intervention
Cancer of the Peri-prostatic Tissue or Prostate Bed	Other: Observation & documentation

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
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

Further study details as provided by Varian Medical:

Primary Outcome Measures:

To collect data on the process of implanting the Calypso Transponder in the prostate bed following radical prostatectomy [ Time Frame: Immediate ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Evaluate the stability of the Calypso transponder in the prostate bed [ Time Frame: 60 days ] [ Designated as safety issue: No ]

Enrollment:	12
Study Start Date:	September 2008
Study Completion Date:	August 2009
Primary Completion Date:	August 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Cohort 1 Patients implanted with the Calypso transponders	Other: Observation & documentation Observation of transponder placement

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients with cancer of the peri-prostatic tissue or prostate bed

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00763152

Locations

United States, Arizona
21C Oncology - Scottsdale
Scottsdale, Arizona, United States, 85251
United States, Missouri
Metropolitan Uro-Rad
St. Louis, Missouri, United States, 63141

Sponsors and Collaborators

Varian Medical

Investigators

Principal Investigator:

Rajanish Singla, MD

Metro Uro-Rad

More Information

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.

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.

Responsible Party:	Jeff Jellum, Calypso Medical Technologies, Inc.
ClinicalTrials.gov Identifier:	NCT00763152 History of Changes
Other Study ID Numbers:	CMT-07-08
Study First Received:	September 25, 2008
Last Updated:	July 12, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by Varian Medical:

prostate
prostate bed
periprostatic

ClinicalTrials.gov processed this record on February 12, 2012