Purpose/Objective: To study the implantation and long-term tolerance of Beacon® transponders, and localization and tracking in patients with localized prostate cancer. Materials/Methods: Calypso 4D Localization System (“Calypso System”, Calypso Medical, Seattle, WA) is an investigational patient positioning device including markers (transponders: 8.5 × 1.85 mm, glass-encapsulated electrical circuits used for permanent implantation), and external electronics that continuously localize the transponders using electromagnetic signals at a 10 Hz rate. Three transponders were implanted with 14G needles at the apex, left and right base under transrectal ultrasound guidance in 20 patients. Adverse event checks were conducted at Day 0 (day of implant), 4, 7, 10, 14 (simulation); Fraction 4, 10, 15, 20; and 1, 6, and 12 months post- RT. CTs or pair of kV X-rays were acquired at Day 0, 4, 7, 10, 14; at Fractions 1, 2, 3, 4, 10, 15, 20; and 1 month post-RT to document transponder geometry and compute inter-transponder distance, a migration indicator. Results: The implantation procedures completed without any major complications. Of 60 transponders, one was presumably implanted in the urethra and subsequently voided (patient was asymptomatic) and one migrated cephalad approx. 3 cm from the apex prior to Day 4 presumably within the venous plexus (the transponder subsequently remained stable). In 2 cases, there was a minimal change in urinary status (IPSS scores) prior to RT. All acute bleeding (hematuria, hematospermia, and/or hematochezia) resolved by Day 10 (n=7). To date, 5/20 subjects have completed the 12-month post-RT follow-up. Dysuria was reported in 11 patients after RT. One case of prostatitis was reported at 6 months, and one patient with a very large prostate gland had urinary obstruction requiring surgical intervention at 8 months post-RT that was considered unrelated to the transponders. Analysis of inter-transponder distances indicated stable geometry in 15/20 patients by Day 4, and in all patients by Day 14. Distances at 4-week post-RT again showed stable geometry. In 11/20 patients, localization and tracking were performed (1 patient not localizable and 8 not evaluated). Comparison of the Calypso System coordinates with transponder locations on X-rays showed average (±+SD) 3D difference between the two systems was 1.5 ± 0.9 mm. Finally, during tracking, 2/11 patients showed significant organ motion (>1 cm) over 8 minutes. Longitudinal and vertical motion followed the same pattern of change, with no significant motion in the lateral direction. The excursions persisted for over one minute. Conclusions: Transrectal implantation of transponders for use with the Calypso System has an acceptable adverse event profile that appears consistent with gold marker implantation. Care should be taken to implant transponders within the prostate gland, off mid-line, to avoid migration. Real-time target position monitoring is possible for the first time without requiring X-rays for imaging. Tracking the prostate showed significant motion over time periods of interest in radiation therapy in some patients. Real-time tracking of organ motion will play an important role in modern external beam radiotherapy.
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