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CMT-07-08: The PROstate Bed Evaluation Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Varian Medical
ClinicalTrials.gov Identifier:
NCT00763152
First received: September 25, 2008
Last updated: April 27, 2012
Last verified: April 2012
  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:

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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