Clinical trial · Interventional
Positioning and Tracking the Prostate During External Beam Radiation
Beacon® Transponder Implantation and Localization in the Prostate
NCT00123838CI-TRIAL-00021959completedN/AClinicalTrials.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)
The purpose of this study is to evaluate a non-ionizing electromagnetic method to align the prostate treatment site for radiation therapy and to monitor its position throughout radiation therapy delivery. The clinical study involves using an investigational device, the Calypso® 4D Localization System, and requires permanent implantation of three small sensors called Beacon® transponders in the prostate.
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 |
|---|---|---|---|
| Calypso® 4D Localization System | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Group Assignment
- description
- Calypso® 4D Localization System
- interventionNames
- Device: Calypso® 4D Localization System
Primary outcomes (1)
- measure
- Radiographic verification of at least five of approximately 40 radiation treatment days
- timeFrame
- 8 weeks
Secondary outcomes (1)
- measure
- Patient Preference Questionnaire and SF 36 Health Survey at five radiation treatment days
- timeFrame
- 8 week
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 18 years of age or older * Histologically confirmed diagnosis of prostate cancer * Intact prostate (minor transurethral resection of the prostate \[TURP\] defects are allowed at the discretion of the investigator) * Ability to comply with study visit schedule Exclusion Criteria: * Prior treatment for prostate cancer. * Prostate cancer stage IV (metastatic disease). * Patients who are not eligible for prostate biopsy. * Past history of abdominoperineal (A-P) resection. * Planned course of treatment using brachytherapy (permanent brachytherapy seeds or high dose rate \[HDR\] brachytherapy). * Allergy to local anesthetics. * Patients with any permanently implanted medical devices that have an energy source, such as pacemakers, defibrillators, neurostimulators, and drug infusion pumps; this also includes prosthetic implants in the abdomen or pelvis, such as an artificial hip; or vascular implants such as arterial stents or stent-grafts for aortic aneurysms. This does not include surgical clips, staples or coronary stents. * History of chronic prostatitis. * Patients with a history of recent acute and/or chronic bleeding disorders. * Patients on therapeutic anti-coagulants or anti-platelet therapy, not including aspirin. * Patients for which the maximum anterior-posterior separation through the torso minus the height of the center of the prostate is greater than 23 cm. (Measurements will be made visually with a ruler.) * Baseline evaluation shows an INR or PTT outside of the normal range for the institution; platelet count \< 75,000 mm3; or creatinine \> 2.0 mg/dl. * Any other medical condition or laboratory value that would, at the discretion of the investigator, preclude the patient from participation in a clinical trial
References
Publications (0)
Data not yet available
No reference posted for this study.