CMT-07-08: The PROstate Bed Evaluation Study - Tabular View

Tracking Information

First Received Date ^ICMJE

September 25, 2008

Last Updated Date

June 22, 2009

Start Date ^ICMJE

September 2008

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00763152 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Descriptive Information

Brief Title ^ICMJE

CMT-07-08: The PROstate Bed Evaluation Study

Official Title ^ICMJE

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

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

Study Phase

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Cohort, Prospective

Condition ^ICMJE

Cancer of the Peri-Prostatic Tissue or Prostate Bed

Intervention ^ICMJE

Other: Observation & documentation

Study Arms / Comparison Groups

Patients implanted with the Calypso transponders

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Completion Date

Primary Completion Date

Eligibility Criteria ^ICMJE

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

Gender

Male

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00763152

Responsible Party

Manager, Clinical Affairs, Calypso Medical Technologies, Inc.

Study ID Numbers ^ICMJE

CMT-07-08

Study Sponsor ^ICMJE

Calypso Medical Technologies

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Rajanish Singla, MD

Metro Uro-Rad

Information Provided By

Calypso Medical Technologies

Verification Date

June 2009

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP