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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


N/A
18 Years
N/A
Not Enrolling
Male
Cancer of the Peri-prostatic Tissue or Prostate Bed

Thank you

Trial Information

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


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

To collect data on the process of implanting the Calypso Transponder in the prostate bed following radical prostatectomy

Outcome Time Frame:

Immediate

Safety Issue:

No

Principal Investigator

Rajanish Singla, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Metro Uro-Rad

Authority:

United States: Institutional Review Board

Study ID:

CMT-07-08

NCT ID:

NCT00763152

Start Date:

September 2008

Completion Date:

August 2009

Related Keywords:

  • Cancer of the Peri-prostatic Tissue or Prostate Bed
  • prostate
  • prostate bed
  • periprostatic

Name

Location

21C Oncology - ScottsdaleScottsdale, Arizona  85251
Metropolitan Uro-RadSt. Louis, Missouri  63141