Application of an interstitial and biodegradable balloon system for prostate-rectum separation during prostate cancer radiotherapy: A prospective multi-center study

Eliahu Gez, Shmuel Cytron, Rahamin Ben Yosef, Daniel London, Benjamin W. Corn, Shlomi Alani, Giovanni Scarzello, Fabrizio Dal Moro, Guido Sotti, Filiberto Zattoni, Ike Koziol, Taryn Torre, Matthew Bassignani, Shalom Kalnicki, Reza Ghavamian, Dukagjin Blakaj, Mitchell Anscher, Martin Sommerauer, Dieter Jocham, Corinna MelchertStefan Huttenlocher, Gyoergy Kovacs, Madhur K. Garg

Research output: Contribution to journalArticle

25 Citations (Scopus)

Abstract

Background and purpose: Rectal toxicity presents a significant limiting factor in prostate radiotherapy regimens. This study evaluated the safety and efficacy of an implantable and biodegradable balloon specifically designed to protect rectal tissue during radiotherapy by increasing the prostate-rectum interspace.Patients and methods: Balloons were transperineally implanted, under transrectal ultrasound guidance, into the prostate-rectum interspace in 27 patients with localized prostate cancer scheduled to undergo radiotherapy. Patients underwent two simulations for radiotherapy planning--the first simulation before implant, and the second simulation seven days post implant. The balloon position, the dimensions of the prostate, and the distance between the prostate and rectum were evaluated by CT/US examinations 1 week after the implant, weekly during the radiotherapy period, and at 3 and 6 months post implant. Dose-volume histograms of pre and post implantation were compared. Adverse events were recorded throughout the study period.Results: Four of 27 patients were excluded from the evaluation. One was excluded due to a technical failure during implant, and three patients were excluded because the balloon prematurely deflated. The balloon status was evaluated for the duration of the radiotherapy period in 23 patients. With the balloon implant, the distance between the prostate and rectum increased 10-fold, from a mean 0.22 ± 0.2 cm to 2.47 ± 0.47 cm. During the radiotherapy period the balloon length changed from 4.25 ± 0.49 cm to 3.81 ± 0.84 cm and the balloon height from 1.86 ± 0.24 cm to 1.67 ± 0.22 cm. But the prostate-rectum interspace distance remained constant from beginning to end of radiotherapy: 2.47 ± 0.47 cm and 2.41 ± 0.43 cm, respectively. A significant mean reduction in calculated rectal radiation exposure was achieved. The implant procedure was well tolerated. The adverse events included mild pain at the perineal skin and in the anus. Three patients experienced acute urinary retention which resolved in a few hours following conservative treatment. No infections or thromboembolic events occurred during the implant procedure or during the radiotherapy period.Conclusion: The transperineal implantation of the biodegradable balloon in patients scheduled to receive radiotherapy was safe and achieved a significant and constant gap between the prostate and rectum. This separation resulted in an important reduction in the rectal radiation dose. A prospective study to evaluate the acute and late rectal toxicity is needed.

Original languageEnglish (US)
Article number96
JournalRadiation Oncology
Volume8
Issue number1
DOIs
StatePublished - Apr 23 2013
Externally publishedYes

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Rectum
Prostate
Prostatic Neoplasms
Radiotherapy
Urinary Retention
Anal Canal
Prospective Studies
Radiation
Safety
Pain
Skin
Infection

Keywords

  • Implantable biodegradable balloon
  • Prostate radiotherapy
  • Prostate-rectum separation

ASJC Scopus subject areas

  • Oncology
  • Radiology Nuclear Medicine and imaging
  • Medicine(all)

Cite this

Application of an interstitial and biodegradable balloon system for prostate-rectum separation during prostate cancer radiotherapy : A prospective multi-center study. / Gez, Eliahu; Cytron, Shmuel; Yosef, Rahamin Ben; London, Daniel; Corn, Benjamin W.; Alani, Shlomi; Scarzello, Giovanni; Dal Moro, Fabrizio; Sotti, Guido; Zattoni, Filiberto; Koziol, Ike; Torre, Taryn; Bassignani, Matthew; Kalnicki, Shalom; Ghavamian, Reza; Blakaj, Dukagjin; Anscher, Mitchell; Sommerauer, Martin; Jocham, Dieter; Melchert, Corinna; Huttenlocher, Stefan; Kovacs, Gyoergy; Garg, Madhur K.

In: Radiation Oncology, Vol. 8, No. 1, 96, 23.04.2013.

Research output: Contribution to journalArticle

Gez, E, Cytron, S, Yosef, RB, London, D, Corn, BW, Alani, S, Scarzello, G, Dal Moro, F, Sotti, G, Zattoni, F, Koziol, I, Torre, T, Bassignani, M, Kalnicki, S, Ghavamian, R, Blakaj, D, Anscher, M, Sommerauer, M, Jocham, D, Melchert, C, Huttenlocher, S, Kovacs, G & Garg, MK 2013, 'Application of an interstitial and biodegradable balloon system for prostate-rectum separation during prostate cancer radiotherapy: A prospective multi-center study', Radiation Oncology, vol. 8, no. 1, 96. https://doi.org/10.1186/1748-717X-8-96
Gez, Eliahu ; Cytron, Shmuel ; Yosef, Rahamin Ben ; London, Daniel ; Corn, Benjamin W. ; Alani, Shlomi ; Scarzello, Giovanni ; Dal Moro, Fabrizio ; Sotti, Guido ; Zattoni, Filiberto ; Koziol, Ike ; Torre, Taryn ; Bassignani, Matthew ; Kalnicki, Shalom ; Ghavamian, Reza ; Blakaj, Dukagjin ; Anscher, Mitchell ; Sommerauer, Martin ; Jocham, Dieter ; Melchert, Corinna ; Huttenlocher, Stefan ; Kovacs, Gyoergy ; Garg, Madhur K. / Application of an interstitial and biodegradable balloon system for prostate-rectum separation during prostate cancer radiotherapy : A prospective multi-center study. In: Radiation Oncology. 2013 ; Vol. 8, No. 1.
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T1 - Application of an interstitial and biodegradable balloon system for prostate-rectum separation during prostate cancer radiotherapy

T2 - A prospective multi-center study

AU - Gez, Eliahu

AU - Cytron, Shmuel

AU - Yosef, Rahamin Ben

AU - London, Daniel

AU - Corn, Benjamin W.

AU - Alani, Shlomi

AU - Scarzello, Giovanni

AU - Dal Moro, Fabrizio

AU - Sotti, Guido

AU - Zattoni, Filiberto

AU - Koziol, Ike

AU - Torre, Taryn

AU - Bassignani, Matthew

AU - Kalnicki, Shalom

AU - Ghavamian, Reza

AU - Blakaj, Dukagjin

AU - Anscher, Mitchell

AU - Sommerauer, Martin

AU - Jocham, Dieter

AU - Melchert, Corinna

AU - Huttenlocher, Stefan

AU - Kovacs, Gyoergy

AU - Garg, Madhur K.

PY - 2013/4/23

Y1 - 2013/4/23

N2 - Background and purpose: Rectal toxicity presents a significant limiting factor in prostate radiotherapy regimens. This study evaluated the safety and efficacy of an implantable and biodegradable balloon specifically designed to protect rectal tissue during radiotherapy by increasing the prostate-rectum interspace.Patients and methods: Balloons were transperineally implanted, under transrectal ultrasound guidance, into the prostate-rectum interspace in 27 patients with localized prostate cancer scheduled to undergo radiotherapy. Patients underwent two simulations for radiotherapy planning--the first simulation before implant, and the second simulation seven days post implant. The balloon position, the dimensions of the prostate, and the distance between the prostate and rectum were evaluated by CT/US examinations 1 week after the implant, weekly during the radiotherapy period, and at 3 and 6 months post implant. Dose-volume histograms of pre and post implantation were compared. Adverse events were recorded throughout the study period.Results: Four of 27 patients were excluded from the evaluation. One was excluded due to a technical failure during implant, and three patients were excluded because the balloon prematurely deflated. The balloon status was evaluated for the duration of the radiotherapy period in 23 patients. With the balloon implant, the distance between the prostate and rectum increased 10-fold, from a mean 0.22 ± 0.2 cm to 2.47 ± 0.47 cm. During the radiotherapy period the balloon length changed from 4.25 ± 0.49 cm to 3.81 ± 0.84 cm and the balloon height from 1.86 ± 0.24 cm to 1.67 ± 0.22 cm. But the prostate-rectum interspace distance remained constant from beginning to end of radiotherapy: 2.47 ± 0.47 cm and 2.41 ± 0.43 cm, respectively. A significant mean reduction in calculated rectal radiation exposure was achieved. The implant procedure was well tolerated. The adverse events included mild pain at the perineal skin and in the anus. Three patients experienced acute urinary retention which resolved in a few hours following conservative treatment. No infections or thromboembolic events occurred during the implant procedure or during the radiotherapy period.Conclusion: The transperineal implantation of the biodegradable balloon in patients scheduled to receive radiotherapy was safe and achieved a significant and constant gap between the prostate and rectum. This separation resulted in an important reduction in the rectal radiation dose. A prospective study to evaluate the acute and late rectal toxicity is needed.

AB - Background and purpose: Rectal toxicity presents a significant limiting factor in prostate radiotherapy regimens. This study evaluated the safety and efficacy of an implantable and biodegradable balloon specifically designed to protect rectal tissue during radiotherapy by increasing the prostate-rectum interspace.Patients and methods: Balloons were transperineally implanted, under transrectal ultrasound guidance, into the prostate-rectum interspace in 27 patients with localized prostate cancer scheduled to undergo radiotherapy. Patients underwent two simulations for radiotherapy planning--the first simulation before implant, and the second simulation seven days post implant. The balloon position, the dimensions of the prostate, and the distance between the prostate and rectum were evaluated by CT/US examinations 1 week after the implant, weekly during the radiotherapy period, and at 3 and 6 months post implant. Dose-volume histograms of pre and post implantation were compared. Adverse events were recorded throughout the study period.Results: Four of 27 patients were excluded from the evaluation. One was excluded due to a technical failure during implant, and three patients were excluded because the balloon prematurely deflated. The balloon status was evaluated for the duration of the radiotherapy period in 23 patients. With the balloon implant, the distance between the prostate and rectum increased 10-fold, from a mean 0.22 ± 0.2 cm to 2.47 ± 0.47 cm. During the radiotherapy period the balloon length changed from 4.25 ± 0.49 cm to 3.81 ± 0.84 cm and the balloon height from 1.86 ± 0.24 cm to 1.67 ± 0.22 cm. But the prostate-rectum interspace distance remained constant from beginning to end of radiotherapy: 2.47 ± 0.47 cm and 2.41 ± 0.43 cm, respectively. A significant mean reduction in calculated rectal radiation exposure was achieved. The implant procedure was well tolerated. The adverse events included mild pain at the perineal skin and in the anus. Three patients experienced acute urinary retention which resolved in a few hours following conservative treatment. No infections or thromboembolic events occurred during the implant procedure or during the radiotherapy period.Conclusion: The transperineal implantation of the biodegradable balloon in patients scheduled to receive radiotherapy was safe and achieved a significant and constant gap between the prostate and rectum. This separation resulted in an important reduction in the rectal radiation dose. A prospective study to evaluate the acute and late rectal toxicity is needed.

KW - Implantable biodegradable balloon

KW - Prostate radiotherapy

KW - Prostate-rectum separation

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