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CompletedNCT00763152Updated Oct 15, 2015

CMT-07-08: The PROstate Bed Evaluation Study

An observational study in Prostate Cancer, sponsored by Varian, a Siemens Healthineers Company. Completed at 2 sites in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2015-10-15.

Sponsored by Varian, a Siemens Healthineers Company · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
12
Ages
18 Years and older
Sex
Male
01

Study 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.

Read the detailed description

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

02

Conditions studied

  • Prostate Cancer

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Keywords

  • prostate
  • prostate bed
  • periprostatic
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 12 is below the median of 200 across 1,181 observational studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Varian, a Siemens Healthineers Company is the lead sponsor of 27 studies on the registry; 6 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 4 (50%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Male
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Patients with cancer of the peri-prostatic tissue or 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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
12 participants (actual)

Groups and cohorts

  • 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

Interventions

  • OtherObservation of transponder stability

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

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What researchers measure

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

07

Study locations

2 sites
  • 21C Oncology - Scottsdale
    Scottsdale, Arizona 85251, United States
  • Metropolitan Uro-Rad
    St. Louis, Missouri 63141, United States
08

References and documents

Publications

  • Balter JM, Wright JN, Newell LJ, Friemel B, Dimmer S, Cheng Y, Wong J, Vertatschitsch E, Mate TP. Accuracy of a wireless localization system for radiotherapy. Int J Radiat Oncol Biol Phys. 2005 Mar 1;61(3):933-7. doi: 10.1016/j.ijrobp.2004.11.009. PubMed 15708277 ↗
  • Litzenberg DW, Willoughby TR, Balter JM, Sandler HM, Wei J, Kupelian PA, Cunningham AA, Bock A, Aubin M, Roach M 3rd, Shinohara K, Pouliot J. Positional stability of electromagnetic transponders used for prostate localization and continuous, real-time tracking. Int J Radiat Oncol Biol Phys. 2007 Jul 15;68(4):1199-206. doi: 10.1016/j.ijrobp.2007.03.030. Epub 2007 May 21. PubMed 17513060 ↗
  • Kupelian P, Willoughby T, Mahadevan A, Djemil T, Weinstein G, Jani S, Enke C, Solberg T, Flores N, Liu D, Beyer D, Levine L. Multi-institutional clinical experience with the Calypso System in localization and continuous, real-time monitoring of the prostate gland during external radiotherapy. Int J Radiat Oncol Biol Phys. 2007 Mar 15;67(4):1088-98. doi: 10.1016/j.ijrobp.2006.10.026. Epub 2006 Dec 21. PubMed 17187940 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 15, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00763152
Lead sponsor
Varian, a Siemens Healthineers Company
Responsible party
Sponsor
First posted
Sep 30, 2008
Start date
Sep 2008
Primary completion
Aug 2009
Completion
Aug 2009
Last update
Oct 15, 2015

Study contacts

Rajanish Singla, MD
principal investigator · Metro Uro-Rad

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2015. You cannot join it, but the record below documents what was studied.

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