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Completed

NCT Number: NCT00763152

CMT-07-08: The PROstate Bed Evaluation Study

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

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Observational

Primary location

21C Oncology - Scottsdale, Scottsdale, Arizona, United States

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Observation of transponder stability

Other

Observation of transponder stability and placement in the prostatic bed following radical prostatectomy

Primary outcomes

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

    Time frame: Immediate

Secondary outcomes

  1. Evaluate the stability of the Calypso transponder in the prostate bed

    Time frame: 60 days

Sponsors and collaborators

Lead sponsor

Varian, a Siemens Healthineers Company

Industry

Registry information

Official study 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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Sep 30, 2008
Registry last updated
Oct 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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