Spacer application for prostate cancer radiation therapy

Future Oncology

Volumn 10, Issue 5, 2014, Pages 851-864

  Pinkawa, Michael ^a  

^a RWTH AACHEN UNIVERSITY   (Germany)

Author keywords

biodegradable balloon; brachytherapy; external beam radiotherapy; hyaluronic acid; hydrogel; intensity modulated radiotherapy; prostate cancer; spacer; toxicity

Indexed keywords

COLLAGEN; HUMAN COLLAGEN; HYALURONIC ACID; UNCLASSIFIED DRUG; HYDROGEL;

ABDOMINAL PAIN; ACUTE TOXICITY; BRACHYTHERAPY; CANCER RADIOTHERAPY; COMPUTER ASSISTED TOMOGRAPHY; DIARRHEA; DOSIMETRY; EXTERNAL BEAM RADIOTHERAPY; GASTROINTESTINAL HEMORRHAGE; GASTROINTESTINAL TOXICITY; HUMAN; HYDROGEL; IMAGE GUIDED RADIOTHERAPY; INFLATABLE SPACER BALLOON; INTENSITY MODULATED RADIATION THERAPY; INTESTINE OBSTRUCTION; META ANALYSIS (TOPIC); MULTICENTER STUDY (TOPIC); NECROSIS; NONHUMAN; PAIN; PHASE 2 CLINICAL TRIAL (TOPIC); PRIORITY JOURNAL; PROSTATE CANCER; RADIATION DOSE REDUCTION; RADIATION INJURY; RANDOMIZED CONTROLLED TRIAL (TOPIC); RECTUM DISEASE; RECTUM FISTULA; RECTUM PAIN; RECTUM PERFORATION; REVIEW; SPACER BALLOON; TENESMUS; TRANSRECTAL ULTRASONOGRAPHY; TREATMENT PLANNING; COMPUTER ASSISTED RADIOTHERAPY; MALE; PATHOLOGY; PROSPECTIVE STUDY; PROSTATE; PROSTATIC NEOPLASMS; RADIATION RESPONSE; RECTUM;

DOSE-RESPONSE RELATIONSHIP, RADIATION; HUMANS; HYDROGEL; MALE; PROSPECTIVE STUDIES; PROSTATE; PROSTATIC NEOPLASMS; RADIOTHERAPY PLANNING, COMPUTER-ASSISTED; RADIOTHERAPY, INTENSITY-MODULATED; RANDOMIZED CONTROLLED TRIALS AS TOPIC; RECTUM;

EID: 84899858137     PISSN: 14796694     EISSN: 17448301     Source Type: Journal    
DOI: 10.2217/fon.13.223     Document Type: Review

References (78)

1. Pinkawa M, Piroth DM, Holy R et al. Prostate-specific antigen kinetics following external-beam radiotherapy and temporary (Ir-192) or permanent (I-125) brachytherapy for prostate cancer. Radiother. Oncol. 96, 25-29 (2010).
2. Heidenreich A, Bellmunt J, Bolla M et al. EAU guidelines on prostate cancer. Part 1: screening, diagnosis, and treatment of clinically localised disease. Eur. Urol. 59, 61-71 (2011).
3. Pinkawa M, Piroth MD, Holy R et al. Combination of dose escalation with technological advances (intensity-modulated and image-guided radiotherapy) is not associated with increased morbidity for patients with prostate cancer. Strahlenther. Onkol. 187, 479-484 (2011).
4. Pinkawa M, Pursch-Lee M, Asadpour B et al. Image-guided radiotherapy for prostate cancer. Implementation of ultrasound-based prostate localization for the analysis of inter- and intrafraction motion. Strahlenther. Onkol. 184, 679-685 (2008).
5. Court LE, Dong L, Taylor N et al. Evaluation of a contour-alignment technique for CT-guided prostate radiotherapy: an intra- and interobserver study. Int. J. Radiat. Oncol. Biol. Phys. 59, 412-418 (2004).
6. Zhu X, Bourland JD, Yuan Y et al. Tradeoffs of integrating real-time tracking into IGRT for prostate cancer treatment. Phys. Med. Biol. 54, N393-N401 (2009).
7. Viani GA, Stefano EJ, Alfonso SL. Higher-than-conventional radiation doses in localized prostate cancer treatment: a meta-analysis of randomized, controlled trials. Int. J. Radiat. Oncol. Biol. Phys. 74, 1405-1418 (2009).
8. Kuban DA, Levy LB, Tucker SL et al. Long-term patterns and survival in a randomized dose-escalation trial for prostate cancer. Who dies of the disease? Int. J. Radiat. Oncol. Biol. Phys. 79, 1310-1317 (2008).
9. Brenner DJ. Fractionation and late rectal toxicity. Int. J. Radiat. Oncol. Biol. Phys. 60, 1013-1015 (2004).
10. Budäus L, Bolla M, Bossi A et al. Functional outcomes and complications following radiation therapy for prostate cancer: a critical analysis of the literature. Eur. Urol. 61, 112-127 (2012).
11. Huang EH, Pollack A, Levy L et al. Late rectal toxicity: dose-volume effects of conformal radiotherapy for prostate cancer. Int. J. Radiat. Oncol. Biol. Phys. 54, 1314-1321 (2002).
12. Akimoto T, Muramatsu H, Takahashi M et al. Rectal bleeding after hypofractionated radiotherapy for prostate cancer: correlation between clinical and dosimetric parameters and the incidence of grade 2 or worse rectal bleeding. Int. J. Radiat. Oncol. Biol. Phys. 60, 1033-1039 (2004).
13. Al-Mamgani A, van Putten WL, Heemsbergen WD et al. Update of dutch multicenter dose-escalation trial of radiotherapy for localized prostate cancer. Int. J. Radiat. Oncol. Biol. Phys. 72, 980-988 (2008).
14. Fiorino C, Sanguineti G, Cozzarini C et al. Rectal dose-volume constraints in high-dose radiotherapy of localized prostate cancer. Int. J. Radiat. Oncol. Biol. Phys. 57, 953-962 (2003).
15. Michalski JM, Winter K, Purdy JA et al. Toxicity after three-dimensional radiotherapy for prostate cancer on RTOG 9406 dose level V. Int. J. Radiat. Oncol. Biol. Phys. 62, 706-713 (2005).
16. 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. 76, S123-S129 (2010).
17. Kuban DA, Tucker SL, Dong L et al. Long-term results of the M.D. Anderson randomized dose-escalation trial for prostate cancer. Int. J. Radiat. Oncol. Biol. Phys. 70, 67-74 (2008).
18. Al-Mamgani A, Heemsbergen WD, Peeters ST, Lebesque JV. Role of intensity-modulated radiotherapy in reducing toxicity in dose escalation for localized prostate cancer. Int. J. Radiat. Oncol. Biol. Phys. 73, 685-691 (2009).
19. Vora S, Wong WW, Schild SE, Ezzel GA, Halyard MJ. Analysis of biochemical control and prognostic factors in patients treated with either low-dose three-dimensional conformal radiation therapy or high-dose intensity-modulated radiotherapy for localized prostate cancer. Int. J. Radiat. Oncol. Biol. Phys. 68, 1053-1058 (2007).
20. Dearnaley D, Syndikus I, Sumo G et al. Conventional versus hypofractionated high-dose intensity-modulated radiotherapy for prostate cancer: preliminary safety results from the CHHiP randomised controlled trials. Lancet Oncol. 13, 43-54 (2012).
21. Kupelian PA, Thakkar VV, Khuntia D et al. Hypofractionated intensity-modulated radiotherapy (70 gy at 2.5 Gy per fraction) for localized prostate cancer: long-term outcomes. Int. J. Radiat. Oncol. Biol. Phys. 63, 1463-1468 (2005).
22. Zelefsky MJ, Chan H, Hunt M et al. Long-term outcome of high dose intensity modulated radiation therapy for patients with clinically localized prostate cancer. J. Urol. 176, 1415-1419 (2006).
23. Zelefsky MJ, Levin EJ, Hunt M et al. 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. 70, 1124-1129 (2008).
24. Pinkawa M, Asadpour B, Piroth MD et al. Health-related quality of life after permanent I-125 brachytherapy and conformal external beam radiotherapy for prostate cancer -A matched-pair comparison. Radiother. Oncol. 91, 225-231 (2009).
25. Sanda MG, Dunn RL, Michalski J et al. Quality of life and satisfaction with outcome among prostate-cancer survivors. N. Engl. J. Med. 358, 1250-1261 (2008).
26. Gelblum DY, Potters L. Rectal complications associated with transperineal interstitial brachytherapy for prostate cancer. Int. J. Radiat. Oncol. Biol. Phys. 48, 119-124 (2000).
27. Lee WR, Bae K, Lawton C et al. Late toxicity and biochemical recurrence after external-beam radiotherapy combined with permanent-source prostate brachytherapy: analysis of Radiation Therapy Oncology Group study 0019. Cancer 109, 1506-1512 (2007).
28. Snyder KM, Stock RG, Hong SM et al. Defining the risk of developing grade 2 proctitis following 125I prostate brachytherapy using rectal dose-volume histogram analysis. Int. J. Radiat. Oncol. Biol. Phys. 50, 335-341 (2001).
29. Pinkawa M, Fischedick K, Treusacher P et al. Dose-volume impact in high-dose-rate Iridium-192 brachytherapy as a boost to external beam radiotherapy for localized prostate cancer -A Phase II study. Radiother. Oncol. 78, 41-46 (2006).
30. Chapet O, Udrescu C, Devonec M et al. Prostate hypofractionated radiation therapy: injection of hyaluronic acid to better preserve the rectal wall. Int. J. Radiat. Oncol. Biol. Phys. 86, 72-76 (2013).
31. Hatiboglu G, Pinkawa M, Vallee JP, Hadaschik B, Hohenfellner M. Application technique: placement of a prostate-rectum spacer in men undergoing prostate radiation therapy. BJU Int. 110, e647-e652 (2012).
32. Melchert C, Gez E, Bohlen G et al. Interstitial biodegradable balloon for reduced rectal dose during prostate radiotherapy: results of a virtual planning investigation based on the pre- and post-implant imaging data of an international multicenter study. Radiother. Oncol. 106, 210-214 (2013).
33. Prada PJ, Fernandez J, Martinez AA et al. Transperineal injection of hyaluronic acid in anterior perirectal fat to decrease rectal toxicity from radiation delivered with intensity modulated brachytherapy or EBRT for prostate cancer patients. Int. J. Radiat. Oncol. Biol. Phys. 69, 95-102 (2007).
34. Prada PJ, Gonzalez H, Menendez C et al. Transperineal injection of hyaluronic acid in the anterior perirectal fat to decrease rectal toxicity from radiation delivered with low-dose-rate brachytherapy for prostate cancer patients. Brachytherapy 8, 210-217 (2009).
35. Noyes WR, Hosford CC, Schultz SE. Human collagen injections to reduce rectal dose during radiotherapy. Int. J. Radiat. Oncol. Biol. Phys. 82, 1918-1922 (2012).
36. Daar E, King L, Nisbet A, Thorpe RB, Bradley DA. Viscosity changes in hyaluronic acid: irradiation and rheological studies. Appl. Radiat. Iso. 68, 746-750 (2010).
37. Wilder RB, Barme GA, Gilbert RF et al. Cross-linked hyaluronan gel reduces the acute rectal toxicity of radiotherapy for prostate cancer. Int. J. Radiat. Oncol. Biol. Phys. 77, 824-830 (2010).
38. Nguyen PL, Devlin PM, Beard CJ et al. High-dose-rate brachytherapy for prostate cancer in a previously radiated patient with polyethylene glycol hydrogel spacing to reduce rectal dose: case report and review of the literature. Brachytherapy 12, 77-83 (2013).
39. 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. 76, 1251-1258 (2010).
40. Kouloulias V, Kalogeropoulos T, Platoni K et al. Feasibilty and radiation induced toxicity regarding the first application of transperineal implementation of biocompatible balloon for high dose radiotherapy in patients with prostate carcinoma. Radiat. Oncol. 8, 82 (2013).
41. Faerber GJ, Richardson TD. Long-term results of transurethral collagen injection in men with intrinsic sphincter deficiency. J. Endourol. 11, 273-277 (1997).
42. Levy Y, Paz A, Yosef RB et al. Biodegradable inflatable balloon for reducing radiation adverse effects in prostate cancer. J. Biomed. Mater. Res. B Appl. Biomater. 91, 855-867 (2009).
43. Cosgrove GR, Delashaw JB, Grotenhuis JA et al. Safety and efficacy of a novel polyethylene glycol hydrogel sealant for watertight dural repair. J. Neurosurg. 106, 52-58 (2007).
44. Garasic JM, Martin L, Anderson RD. Acute evaluation of the Mynx vascular closure device during arterial re-puncture in an ovine model. J. Invasive Cardiol. 21, 283-285 (2009).
45. Bertolaccini L, Lyberis P, Manno E. Lung sealant and morbidity after pleural decortication: a prospective randomized, blinded study. J. Cardiothorac. Surg. 5, 45 (2010).
46. Pinkawa M, Corral NE, Caffaro M et al. Application of a spacer gel to optimize three-dimensional conformal and intensity modulated radiotherapy for prostate cancer. Radiother. Oncol. 100, 436-441 (2011).
47. Uhl M, van TB, Eble MJ et al. Low rectal toxicity after dose escalated IMRT treatment of prostate cancer using an absorbable hydrogel for increasing and maintaining space between the rectum and prostate: results of a multi-institutional Phase II trial. Radiother. Oncol. 106, 215-219 (2013).
48. Pinkawa M, Piroth MD, Holy R et al. Spacer stability and prostate position variability during radiotherapy for prostate cancer applying a hydrogel to protect the rectal wall. Radiother. Oncol. 106, 220-224 (2013).
49. Vasavada AR, Singh R, Apple DJ et al. Effects of hydrodissection on intraoperative performance: randomized study. J. Cataract Refract. Surg. 28, 1623-1628 (2002).
50. Malone D, Clark T, Wei N. Ultrasound-guided percutaneous injection, hydrodissection, and fenestration for carpal tunnel syndrome: description of a new technique. J. Appl. Res. 10, 116-123 (2010).
51. Villers A, McNeal JE, Freiha FS, Boccon-Gibod L, Stamey TA. Invasion of Denonvilliers' fascia in radical prostatectomy specimens. J. Urol. 149, 793-798 (1993).
52. Pinkawa M, Klotz J, Djukic V et al. Learning curve in the application of a hydrogel spacer to protect the rectal wall during radiotherapy of localized prostate cancer. Urology 82(4), 963-968 (2013).
53. Pinkawa M, Djukic V, Holy R et al. Anwendung eines abstandhalters zwischen prostata und rektumvorderwand zur optimierung der radiotherapie des lokal begrenzten prostatakarzinoms. Strahlenther. Onkol. 187(Suppl. 1), 42-43 (2011).
54. Lawton CAF, Michalski J, El-Naqa I et al. RTOG GU radiation oncology specialists reach consensus on pelvic lymph node volumes for high-risk prostate cancer. Int. J. Radiat. Oncol. Biol. Phys. 74, 383-387 (2009).
55. Song DY, Herfarth KK, Uhl M et al. A multi-institutional clinical trial of rectal dose reduction via injected polyethylene-glycol hydrogel during intensity modulated radiation therapy for prostate cancer: analysis of dosimetric outcomes. Int. J. Radiat. Oncol. Biol. Phys. 87(1), 81-87 (2013).
56. Yang Y, Ford EC, Wu B et al. An overlap-volume-histogram based method for rectal dose prediction and automated treatment planning in the external beam prostate radiotherapy following hydrogel injection. Med. Phys. 40, 011709 (2013).
57. Pinkawa M, Attieh C, Piroth MD et al. Dose-escalation using intensity-modulated radiotherapy for prostate cancer - evaluation of the dose distribution with and without 18F-choline PET-CT detected simultaneous integrated boost. Radiother. Oncol. 93, 213-219 (2009).
58. Pinkawa M, Asadpour B, Gagel B et al. Prostate position variability and dose-volume histograms in radiotherapy for prostate cancer with full and empty bladder. Int. J. Radiat. Oncol. Biol. Phys. 64, 856-861 (2006).
59. Pinkawa M, Asadpour B, Siluschek J et al. Bladder extension variability during pelvic external beam radiotherapy with a full or empty bladder. Radiother. Oncol. 83, 163-167 (2007).
60. Pinkawa M, Siluschek J, Gagel B et al. Influence of the initial rectal distension on posterior margins in primary and postoperative radiotherapy for prostate cancer. Radiother. Oncol. 81, 284-290 (2006).
61. Anderson NS, Yu JB, Peschel RE, Decker RH. A significant decrease in rectal volume and diameter during prostate IMRT. Radiother. Oncol. 98, 187-191 (2011).
62. Pinkawa M, Bornemann C, Escobar-Corral N et al. Treatment planning shortly after injection of a hydrogel spacer to protect the rectal wall during radiotherapy of prostate cancer. Strahlenther. Onkol. 82(4), 963-968 (2013).
63. Beydoun N, Bucci JA, Chin YS et al. First report of transperineal polyethylene glycol hydrogel spacer use to curtail rectal radiation dose after permanent iodine-125 prostate brachytherapy. Brachytherapy 12, 368-374 (2013).
64. Weber DC, Zilli T, Vallee JP et al. Intensity modulated proton and photon therapy for early prostate cancer with or without transperineal injection of a polyethylen glycol spacer: a treatment planning comparison study. Int. J. Radiat. Oncol. Biol. Phys. 84, e311-e318 (2012).
65. Smeenk JR, Teh BS, Butler EB et al. Is there a role for endorectal balloons in prostate radiotherapy? A systematic review. Radiother. Oncol. 95, 277-282 (2010).
66. van Lin EN, Hoffmann AL, van KP et al. Rectal wall sparing effect of three different endorectal balloons in 3D conformal and IMRT prostate radiotherapy. Int. J. Radiat. Oncol. Biol. Phys. 63, 565-576 (2005).
67. Wilder RB, Barne GA, Gilbert RF et al. Cross-linked hyaluronan gel improves the quality of life of prostate cancer patients undergoing radiotherapy. Brachytherapy 10, 44-50 (2011).
68. Gez E, Cytron S, Yosef RB et al. Application of an interstitial and biodegradable balloon system for prostate-rectum separation during prostate cancer radiotherapy: a prospective multi-center study. Radiat. Oncol. 8, 96 (2013).
69. Prada PJ, Jimenez I, Gonzalez-Suarez H et al. High-dose-rate interstitial brachytherapy as monotherapy in one fraction and transperineal hyaluronic acid injection into the perirectal fat for the treatment of favorable stage prostate cancer: treatment description and preliminary results. Brachytherapy 11, 105-110 (2012).
70. Burman C, Kutcher GJ, Emami B, Goitein M. Fitting of normal tissue tolerance data to an analytic function. Int. J. Radiat. Oncol. Biol. Phys. 21, 123-135 (1991).
71. Luxton G, Keall PJ, King CR. A new formula for normal tissue complication probability (NTCP) as a function of equivalent uniform dose (EUD). Phys. Med. Biol. 53, 23-26 (2008).
72. Pinkawa M, Fischedick K, Asadpour B et al. Toxicity profile with a large prostate volume after external beam radiotherapy for localized prostate cancer. Int. J. Radiat. Oncol. Biol. Phys. 70, 83-89 (2008).
73. Volz-Sidiropoulou E, Pinkawa M, Fischedick K et al. Factor analysis of the Expanded Prostate Cancer Index Composite (EPIC) in a patient group after primary (external beam radiotherapy and permanent iodine-125 brachytherapy) and postoperative radiotherapy for prostate cancer. Curr. Urol. 2, 122-129 (2008).
74. Pinkawa M, Holy R, Piroth DM et al. Interpreting the clinical significance of quality of life score changes after radiotherapy for localized prostate cancer. Curr. Urol. 5137-5144 (2011).
75. Pinkawa M, Piroth MD, Holy R et al. Quality of life after intensity-modulated radiotherapy for prostate cancer with a hydrogel spacer - matched-pair comparisons. Strahlenther. Onkol. 188, 917-925 (2012).
76. Eckert F, Alloussi S, Paulsen F et al. Prospective evaluation of a hydrogel spacer for rectal separation in dose-escalated intensity-modulated radiotherapy for clinically localized prostate cancer. BMC Cancer 13, 27 (2013).
77. Pinkawa M, Holy R, Piroth MD et al. Consequential late effects after radiotherapy for prostate cancer -A prospective longitudinal quality of life study. Radiat. Oncol. 5, 27 (2010).
78. Arcangeli G, Fowler J, Gomellini S et al. Acute and late toxicity in a randomized trial of conventional versus hypofractionated three-dimensional conformal radiotherapy for prostate cancer. Int. J. Radiat. Oncol. Biol. Phys. 79, 1013-1021 (2011).