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

Radiation Oncology

Madhur Garg¹  Gyoergy Kovacs¹  Stefan Huttenlocher¹  Corinna Melchert¹  Dieter Jocham¹  Martin Sommerauer¹  Mitchell Anscher¹  Dukagjin Blakaj¹  Reza Ghavamian¹  Shalom Kalnicki¹  Matthew Bassignani¹  Taryn Torre¹  Ike Koziol¹  Filiberto Zattoni¹  Guido Sotti¹  Fabrizio Dal Moro¹  Giovanni Scarzello¹  Shlomi Alani¹  Benjamin W Corn¹  Daniel London¹  Rahamin Ben Yosef¹  Shmuel Cytron¹  Eliahu Gez¹ 

[1] Tel Aviv Sourasky Medical Center, Department of Radiation Oncology, 6 Weizmann Street, Tel Aviv, 64239, Israel

关键词: Prostate radiotherapy;    Prostate-rectum separation;    Implantable biodegradable balloon;   

Others  :  1154129
DOI  :  10.1186/1748-717X-8-96

 received in 2012-11-19, accepted in 2013-03-28,  发布年份 2013

【 摘 要 】

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.

【 授权许可】

   
2013 Gez et al.; licensee BioMed Central Ltd.

【 图 表 】

Figure 1.

Figure 2.

Figure 3.

【 参考文献 】

• [1]Martinez AA, Gonzalez J, Ye H, Ghilezan M, Shetty S, Kernen K, Gustafson G, Krauss D, Vicini F, Kestin L: Dose escalation improves cancer-related events at 10 years for intermediate- and high-risk prostate cancer pts treated with hypofractionated high-dose-rate boost and external beam radiotherapy. Int J Radiat Oncol Biol Phys 2011, 79:363-70.
• [2]Zelefsky MJ, Pei X, Chou JF, Schechter M, Kollmeier M, Cox B, Yamada Y, Fidaleo A, Sperling D, Happersett L, Zhang Z: Dose escalation for prostate cancer radiotherapy: predictors of long-term biochemical tumor control and distant metastases-free survival outcomes. Eur Urol 2011, 60:1133-9.
• [3]Prada PJ, Mendez L, Fernández J, González H, Jiménez I, Arrojo E: Long-term biochemical results after high-doserate intensity modulated brachytherapy with external beam radiotherapy for high risk prostate cancer. Radiat Oncol 2012, 7:31-38. BioMed Central Full Text
• [4]Zelefsky MJ, Levin EJ, Hunt M, Yamada Y, Shippy AM, Jackson A, Amols HI: Incidence of late rectal and urinary toxicities after three-dimensional conformal radiotherapy and intensity-modulated radiotherapy for localized prostate cancer. Int J Radiat Oncol Biol Phys 2008, 70:1124-9.
• [5]Dolezel M, Odrazka K, Vaculikova M, Vanasek J, Sefrova J, Paluska P, Zouhar M, Jansa J, Macingova Z, Jarosova L, Brodak M, Moravek P, Hartmann: Dose Escalation in Prostate Radiotherapy up to 82Gy Using Simultaneous Integrated Boost Direct Comparison of Acute and Late Toxicity with 3D-CRT 74Gy and IMRT 78Gy. Strahlenther Onkol 2010, 186:197-202.
• [6]Syndikus IMorgan RC Syndikus I, Morgan RC, Sydes MR, Graham JD, Dearnaley DP: MRC RT01 collaborators: Late gastrointestinal toxicity after dose-escalated conformal radiotherapy for early prostate cancer: results from the UK Medical Research Council RT01 trial (ISRCTN47772397). Int J Radiat Oncol Biol Phys. 2010, 77:773-83.
• [7]Gill S, Thomas J, Fox C, Kron T, Rolfo A, Leahy M, Chander S, Williams S, Tai KH, Duchesne GM: Acute toxicity in prostate cancer patients treated with and without image-guided radiotherapy. Radiat Oncol 2011, 6:145-15. BioMed Central Full Text
• [8]Takemoto S, Shibamoto Y, Ayakawa S, Nagai A, Hayashi A, Ogino H, Baba F, Yanagi T, Sugie C, Kataoka H, Mimura M: Treatment and prognosis of patients with late rectal bleeding after intensity-modulated radiation therapy for prostate cancer. Radiat Oncol 2012, 7:87-94. BioMed Central Full Text
• [9]Susil RC, McNutt TR, DeWeese TL, Song D: Effects of prostate-rectum separation on rectal dose from external beam radiotherapy. Int J Radiat Oncol Biol Phys 2010, 76:1251-1258.
• [10]Pinkawa M, Corral NE, Caffaro M, Piroth MD, Holy R, Djukic V, Otto G, Schoth F, Eble MJ: Application of a spacer gel to optimize three-dimensional conformal and intensity modulated radiotherapy for prostate cancer. Radiother Oncol 2011, 100:436-41.
• [11]Pinkawa M, Piroth MD, Holy R, Escobar-Corral N, Caffaro M, Djukic V, Klotz J, Eble MJ: Quality of life after intensity-modulated radiotherapy for prostate cancer with a hydrogel spacer. Matched-pair analysis. Strahlenther Onkol 2012, 10:917-25.
• [12]Noyes WR, Hosford CC, Schultz SE: Human collagen injections to reduce rectal dose during radiotherapy. Int J Radiat Oncol Biol Phys 2012, 82:1918-22.
• [13]Wachter S, Gerstner N, Dorner D, Goldner G, Colotto A, Wambersie A, Pötter: The influence of a rectal balloon tube as internal immobilization device on variations of volumes and dose-volume histograms during treatment course of conformal radiotherapy for prostate cancer. Int J Radiat Oncol Biol Phys 2002, 52:91-100.
• [14]Levy Y, Paz A, Yosef RB, Corn BW, Vaisman B, Shuhat S, Domb AJ: Biodegradable inflatable balloon for reducing radiation adverse effects in prostate cancer. J Biomed Mater Res B Appl Biomater 2009, 91:855-867.
• [15]Ben-Yosef R, Paz A, Levy Y, Alani S, Muncher Y, Shohat S, Domb A, Corn B: A novel device for protecting rectum during prostate cancer irradiation: in vivo data on a large mammal model. J Urol 2009, 181:1401-1406.
• [16]Cambria R, Jereczek-Fossa BA, Cattani F, Garibaldi C, Zerini D, Fodor C, Serafini F, Pedroli G, Orecchia R: Evaluation of late rectal toxicity after conformal radiotherapy for prostate cancer A comparison between dose-volume constraints and NTCP use. Strahlenther Onkol 2009, 185:384-389.
• [17]Nguyen PL, Chen MH, Hoffman KE, Chen RC, Hu JC, Bennett CL, Kattan MW, Sartor O, Stein K, D’Amico AV: Rectal dose-volume histogram parameters are associated with long-term patient-reported gastrointestinal quality of life after conventional and high-dose radiation for prostate cancer: a subgroup analysis of a randomized trial. Int J Radiat Oncol Biol Phys 2010, 78:1081-1085.
• [18]Michalski JM, Gay H, Jackson A, Tucker SL, Deasy JO: Radiation dose-volume effects in radiation-induced rectal injury. Int J Radiat Oncol Biol Phys 2010, 76(3):S123-9.
• [19]Pederson AW, Fricano J, Correa D, Pelizzari CA, Liauw SL: Late toxicity after intensity-modulated radiation therapy for localized prostate cancer: an exploration of dose-volume histogram parameters to limit genitourinary and gastrointestinal toxicity. Int J Radiat Oncol Biol Phys 2012, 82:235-41.
• [20]National Cancer Institute, Cancer Therapy Evaluation Program: “Common Terminology Criteria for Adverse Events, version 3.0.”. 2003. http://ctep.cancer.gov/ webcite
• [21]Keita H, Diouf E, Tubach F, Brouwer T, Dahmani S, Mantz J, Desmonts JM: Predictive Factors of Early Postoperative Urinary Retention in the Post anesthesia Care Unit. Anesth Analg 2005, 101:592-596.