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CMT-07-08: The PROstate Bed Evaluation Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00763152
Recruitment Status : Completed
First Posted : September 30, 2008
Last Update Posted : October 15, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Prostate Cancer Other: Observation of transponder stability

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

Study Design

Study Type : Observational
Actual Enrollment : 12 participants
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
Study Start Date : September 2008
Primary Completion Date : August 2009
Study Completion Date : August 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
stability of Beacons in prostatic bed
Patients implanted with the Calypso transponders following radical prostatectomy for prostate cancer will be followed for observation of transponder stability.
Other: Observation of transponder stability
Observation of transponder stability and placement in the prostatic bed following radical prostatectomy


Outcome Measures

Primary Outcome Measures :
  1. To collect data on the process of implanting the Calypso Transponder in the prostate bed following radical prostatectomy [ Time Frame: Immediate ]

Secondary Outcome Measures :
  1. Evaluate the stability of the Calypso transponder in the prostate bed [ Time Frame: 60 days ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes 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:

  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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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