Clinical trial · Observational
CMT-07-08: The PROstate Bed Evaluation Study
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
NCT00763152CI-TRIAL-00019487completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an observational study to collect placement and tracking data for patients who have the Calypso transponders implanted into the peri-prostatic tissue.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Observation of transponder stability | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- stability of Beacons in prostatic bed
- description
- Patients implanted with the Calypso transponders following radical prostatectomy for prostate cancer will be followed for observation of transponder stability.
- interventionNames
- Other: Observation of transponder stability
Primary outcomes (1)
- measure
- To collect data on the process of implanting the Calypso Transponder in the prostate bed following radical prostatectomy
- timeFrame
- Immediate
Secondary outcomes (1)
- measure
- Evaluate the stability of the Calypso transponder in the prostate bed
- timeFrame
- 60 days
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (3)
- BACKGROUNDBalter 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. PMID 15708277
- BACKGROUNDLitzenberg 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. PMID 17513060
- BACKGROUNDKupelian 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. PMID 17187940