Absorbable hydrogel spacer use in men undergoing prostate cancer radiotherapy: 12 month toxicity and proctoscopy results of a prospective multicenter phase II trial

Radiation Oncology

Volumn 9, Issue 1, 2014, Pages

  Uhl, Matthias ^a   Herfarth, Klaus ^a   Eble, Michael J ^b   Pinkawa, Michael ^b   van Triest, Baukelien ^c   Kalisvaart, Robin ^c   Weber, Damien C ^d   Miralbell, Raymond ^d   Song, Danny Y ^e   DeWeese, Theodore L ^e  

^a UNIVERSITY OF HEIDELBERG   (Germany)

^b RWTH AACHEN UNIVERSITY   (Germany)

^c NETHERLANDS CANCER INSTITUTE   (Netherlands)

^d GENEVA UNIVERSITY HOSPITALS   (Switzerland)

^e JOHNS HOPKINS UNIVERSITY SCHOOL OF MEDICINE   (United States)

Author keywords

Hydrogel; IMRT; Prostate cancer; Radiotherapy; Rectal toxicity; Spacer

Indexed keywords

MACROGOL; HYDROGEL;

ADULT; AGED; ARTICLE; CANCER RADIOTHERAPY; CANCER SIZE; DOSIMETRY; FOLLOW UP; GASTROINTESTINAL SYMPTOM; HUMAN; HYDROGEL ORGAN SPACER; HYDROGEL PROSTATE RECTUM SPACER; INTENSITY MODULATED RADIATION THERAPY; MAJOR CLINICAL STUDY; MALE; MIDDLE AGED; MUCOSAL NECROSIS; MULTICENTER STUDY; NUCLEAR MAGNETIC RESONANCE IMAGING; OPEN STUDY; PROSPECTIVE STUDY; PROSTATE CANCER; RADIATION INJURY; RADIATION NECROSIS; RATING SCALE; RECTOSCOPY; RECTUM INJURY; TELANGIECTASIA; UROGENITAL TRACT DISEASE; VIENNA RECTOSCOPY SCALE; CANCER STAGING; CLINICAL TRIAL; GASTROINTESTINAL TRACT; HYDROGEL; ORGANS AT RISK; PHASE 2 CLINICAL TRIAL; PROGNOSIS; PROSTATIC NEOPLASMS; RADIATION DOSE; RADIATION INJURIES; RADIATION RESPONSE; TIME; UROGENITAL SYSTEM;

AGED; FOLLOW-UP STUDIES; GASTROINTESTINAL TRACT; HUMANS; HYDROGEL; MALE; NEOPLASM STAGING; ORGANS AT RISK; PROCTOSCOPY; PROGNOSIS; PROSPECTIVE STUDIES; PROSTATIC NEOPLASMS; RADIATION INJURIES; RADIOTHERAPY DOSAGE; TIME FACTORS; UROGENITAL SYSTEM;

EID: 84900020198     PISSN: None     EISSN: 1748717X     Source Type: Journal    
DOI: 10.1186/1748-717X-9-96     Document Type: Article

References (21)

1. Malvezzi M, Bertuccio P, Levi F, La Vecchia C, Negri E. European cancer mortality predictions for the year 2013. Ann Oncol 2013, 24:792-800. 10.1093/annonc/mdt010, 23402763.
2. Jemal A, Bray F, Center MM, Ferlay J, Ward E, Forman D. Global cancer statistics. CA Cancer J Clin 2011, 61:69-90. 10.3322/caac.20107, 21296855.
3. Bucci MK, Bevan A, Roach M. Advances in radiation therapy: conventional to 3D, to IMRT, to 4D, and beyond. CA Cancer J Clin 2005, 55:117-134. 10.3322/canjclin.55.2.117, 15761080.
4. Heidenreich A, Bellmunt J, Bolla M, Joniau S, Mason M, Matveev V, Mottet N, Schmid HP, van der Kwast T, Wiegel T, Zattoni F, . European Association of Urology EAU guidelines on prostate cancer. Part 1: screening, diagnosis, and treatment of clinically localised disease. Eur Urol 2011, 59:61-71. 10.1016/j.eururo.2010.10.039, 21056534, European Association of Urology.
5. Viani GA, Stefano EJ, Afonso SL. Higher-than-conventional radiation doses in localized prostate cancer treatment: a meta-analysis of randomized controlled trials. Int J Radiat Oncol Biol Phys 2009, 74:1405-1418. 10.1016/j.ijrobp.2008.10.091, 19616743.
6. Kuban DA, Tucker SL, Dong L, Starkschall G, Huang EH, Cheung MR, Lee AK, Pollack A. Long-term results of the M. D. Anderson randomized dose-escalation trial for prostate cancer. Int J Radiat Oncol Biol Phys 2008, 70:67-74. 10.1016/j.ijrobp.2007.06.054, 17765406.
7. Zelefsky MJ, Fuks Z, Hunt M, Lee HJ, Lombardi D, Ling CC, Reuter VE, Venkatraman ES, Leibel SA. High dose radiation delivered by intensity modulated conformal radiotherapy improves the outcome of localized prostate cancer. J Urol 2001, 166:876-881. 10.1016/S0022-5347(05)65855-7, 11490237.
8. Zietman AL, Bae K, Slater JD, Shipley WU, Efstathiou JA, Coen JJ, Bush DA, Lunt M, Spiegel DY, Skowronski R, Jabola BR, Rossi CJ. Randomized trial comparing conventional-dose with high-dose conformal radiation therapy in early-stage adenocarcinoma of the prostate: long-term results from proton radiation oncology group/american college of radiology 95-09. J Clin Oncol 2010, 28:1106-1111. 10.1200/JCO.2009.25.8475, 2834463, 20124169.
9. Heemsbergen WD, Peeters ST, Koper PC, Hoogeman MS, Lebesque JV. Acute and late gastrointestinal toxicity after radiotherapy in prostate cancer patients: consequential late damage. Int J Radiat Oncol Biol Phys 2006, 66:3-10. 10.1016/j.ijrobp.2006.03.055, 16814954.
10. Noyes WR, Hosford CC, Schultz SE. Human collagen injections to reduce rectal dose during radiotherapy. Int J Radiat Oncol Biol Phys 2012, 82:1918-1922. 10.1016/j.ijrobp.2011.02.034, 21514738.
11. Prada PJ, Fernandez J, Martinez AA, de la Rúa A, Gonzalez JM, Fernandez JM, Juan G. 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 2007, 69:95-102. 10.1016/j.ijrobp.2007.02.034, 17707267.
12. Wilder RB, Barme GA, Gilbert RF, Holevas RE, Kobashi LI, Reed RR, Solomon RS, Walter NL, Chittenden L, Mesa AV, Agustin J, Lizarde J, Macedo J, Ravera J, Tokita KM. Cross-linked hyaluronan gel reduces the acute rectal toxicity of radiotherapy for prostate cancer. Int J Radiat Oncol Biol Phys 2010, 77:824-830. 10.1016/j.ijrobp.2009.05.069, 20510195.
13. Song DY, Herfarth KK, Uhl M, Eble MJ, Pinkawa M, van Triest B, Kalisvaart R, Weber DC, Miralbell R, Deweese TL, Ford EC. 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 2013, 87:81-87. 10.1016/j.ijrobp.2012.12.019, 3737267, 23414766.
14. Uhl M, van Triest B, Eble MJ, Weber DC, Herfarth K, De Weese TL. 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 2013, 106:215-219. 10.1016/j.radonc.2012.11.009, 23333011.
15. 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 2012, 110:E647-E652. 10.1111/j.1464-410X.2012.11373.x, 22788857.
16. Cox JD, Stetz J, Pajak TF. Toxicity criteria of the Radiation Therapy Oncology Group (RTOG) and the European Organization for Research and Treatment of Cancer (EORTC). Int J Radiat Oncol Biol Phys 1995, 31(5):1341-1346. 10.1016/0360-3016(95)00060-C, 7713792.
17. Wachter S, Gerstner N, Goldner G, Potzi R, Wambersie A, Potter R. Endoscopic scoring of late rectal mucosal damage after conformal radiotherapy for prostatic carcinoma. Radiother Oncol 2000, 54:11-19. 10.1016/S0167-8140(99)00173-5, 10719695.
18. Lips IM, Dehnad H, van Gils CH, Boeken Kruger AE, van der Heide UA, van Vulpen M. High-dose intensity-modulated radiotherapy for prostate cancer using daily fiducial marker-based position verification: acute and late toxicity in 331 patients. Radiat Oncol 2008, 3:15. 10.1186/1748-717X-3-15, 2430572, 18495016.
19. Vora SA, Wong WW, Schild SE, Ezzell GA, Halyard MY. 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 2007, 68:1053-1058. 10.1016/j.ijrobp.2007.01.043, 17398023.
20. Ippolito E, Massaccesi M, Digesu C, Deodato F, Macchia G, Pirozzi GA, Cilla S, Cuscunà D, Di Lallo A, Mattiucci GC, Mantini G, Pacelli F, Valentini V, Cellini N, Ingrosso M, Morganti AG. Early proctoscopy is a surrogate endpoint of late rectal toxicity in prostate cancer treated with radiotherapy. Int J Radiat Oncol Biol Phys 2012, 83:e191-e195. 10.1016/j.ijrobp.2011.06.1960, 22361084.
21. Goldner G, Tomicek B, Becker G, Geinitz H, Wachter S, Zimmermann F, Wachter-Gerstner N, Reibenwein J, Glocker S, Bamberg M, Feldmann H, Pötzi R, Molls M, Pötter R. Proctitis after external-beam radiotherapy for prostate cancer classified by Vienna rectoscopy score and correlated with EORTC/RTOG score for late rectal toxicity: results of a prospective multicenter study of 166 patients. Int J Radiat Oncol Biol Phys 2007, 67:78-83. 10.1016/j.ijrobp.2006.08.055, 17189064.