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Significant Rectal Dose Reduction During Prostate Cancer Radiotherapy Using Novel

Biodegradable Inflatable Balloon System: Interim Results of a Prospective Multi-Center


Study

Author Block: G. Kovacs1, G. Scarzello2, I. Koziol3, M. Anscher4, S. Cytron5, T. Torre6, F. Dal Moro7, D.
Jocham8, R. Ben Yosef9, E. Gez9, 1University Hospital Schleswig-Holstein, Radiotherapy, Luebeck 23538,

Germany, 2Padova University Hospital, Padova, Padova, Italy, 3VA Urology,, Richmond, VA,, VA, 4Virginia
Commonwealth University, Richmond, VA, 5Barzilai Medical Center, Ashkelon, Israel, 6VA Urology,,
Richmond, VA, 7Padova University Hospital, Padova, Italy, 8University Hospital Schleswig-Holstein,
Urology, Luebeck 23538, Germany, 9TASMC, Tel Aviv, Israel
Abstract:
Purpose: To evaluate the safety and efficacy of an inflatable, biodegradable balloon transperineally
inserted prior to prostate XRT to achieve rectal-prostate separation, resulting in lower rectal doses.
Materials & Methods: 15 patients with prostate cancer to be treated with XRT enrolled to a multicenter prospective study to undergo balloon implantation prior to XRT. The device material is a copolymer of poly lactide acid and epsilon caprolactone which is designed to degrade in situ after 3-6
months from placement (study follow-up is 6 months). Placement was performed under TRUS guidance
in lithotomy position. The device is inserted transperineally by an introducer under local/general
anesthesia. Once the introducer is in situ, 5-10cc of saline is injected to create space for subsequent
balloon inflation. Prior to implantation, baseline CT/MRI scans were obtained and compared to postballoon placement scans. Weekly CT or US scans were performed during XRT and at 3 and 6 months post
implantation to insure stability and degradation of the device. XRT plans were generated on the pre and
post-implantation CT scans to measure the reduction of rectal wall exposed to 50%, 70%, 90% and
100% of the prescription dose (D50, D70, D90 and D100).
Results: In all cases the balloon was placed in midline between the prostate and the rectum without
complications. The last 4 cases required 10-15 minutes and were performed with local anesthesia only.
The median balloon measurements in situ are: A-P - 19.2 mm (ranged 14.6 - 23.4), width - 30.5 mm
(21.1 - 36.6) and cranio-caudal - 45mm. These separations resulted in an average reduction of the
rectal D50, D70, D90 and D100 to be 27.1% (from volume of 56.3% 13.6%, to volume of 37.5%
23%), 50.5% (from 33.1% 11.3% to 17.4% 14.8%), 69.9% (from 17.0% 11.6% to 4.8%
4.3%) and 84.9% (from 10.4% 6.5% to 1.5% 1.4%), respectively. In all subjects, there was
minimal or no discomfort at the perineum and no rectal related symptoms. Weekly follow up
demonstrated stable separation and no change in balloon position and shape in 12 cases. In 3 cases the
balloon deflated prematurely due to contact with fiducial markers introduced transrectally. No premature
deflation occurred in cases where the markers inserted transperineally. The balloons degraded as planned
within 3-6 months.
Conclusions: Insertion of the balloon proved to be safe with no unexpected side effects or
complications. The balloon presence resulted in a stable separation of the prostate from the rectum and a
dramatic reduction of the radiation dose to it.

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