Interdisciplinary consensus statement on indication and application of a hydrogel spacer for prostate radiotherapy based on experience in more than 250 patients

1Viani 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; 74:1405-18.VianiGAStefanoEJAfonsoSLHigher-than-conventional radiation doses in localized prostate cancer treatment: a meta-analysis of randomized, controlled trialsInt J Radiat Oncol Biol Phys20097414051810.1016/j.ijrobp.2008.10.091Search in Google Scholar

2Dearnaley D, Syndikus I, Sumo G, Bidmead M, Bloomfield D, Clark C, et al. Conventional versus hypofractionated high-dose intensity-modulated radiotherapy for prostate cancer: preliminary safety results from the CHHiP randomised controlled trial. Lancet Oncol 2012; 13:43-54.DearnaleyDSyndikusISumoGBidmeadMBloomfieldDClarkCConventional versus hypofractionated high-dose intensity-modulated radiotherapy for prostate cancer: preliminary safety results from the CHHiP randomised controlled trialLancet Oncol201213435410.1016/S1470-2045(11)70293-5Search in Google Scholar

3Hat iboglu 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:E647-52.HatibogluGPinkawaMValleeJPHadaschikBHohenfellnerMApplication technique: placement of a prostate-rectum spacer in men undergoing prostate radiation therapyBJU Int2012110E6475210.1111/j.1464-410X.2012.11373.x22788857Search in Google Scholar

4Eckert F, Alloussi S, Paulsen F, Bamberg M, Zips D, Spillner P, et al. Prospective evaluation of a hydrogel spacer for rectal separation in dose-escalated intensity-modulated radiotherapy for clinically localized prostate cancer. BMC Cancer 2013; 13: 27.EckertFAlloussiSPaulsenFBambergMZipsDSpillnerPProspective evaluation of a hydrogel spacer for rectal separation in dose-escalated intensity-modulated radiotherapy for clinically localized prostate cancerBMC Cancer2013132710.1186/1471-2407-13-27355840223336502Search in Google Scholar

5Pinkawa M, Piroth MD, Holy R, Escobar-Corral N, Caffaro M, Djukic V, et al. Spacer stability and prostate position variability during radiotherapy for prostate cancer applying a hydrogel to protect the rectal wall. Radiother Oncol 2013; 106: 220-4.PinkawaMPirothMDHolyREscobar-CorralNCaffaroMDjukicVSpacer stability and prostate position variability during radiotherapy for prostate cancer applying a hydrogel to protect the rectal wallRadiother Oncol2013106220410.1016/j.radonc.2012.11.01023333015Search in Google Scholar

6Uhl 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: 215-19.UhlMvan TriestBEbleMJWeberDCHerfarthKDe WeeseTLLow 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 trialRadiother Oncol20131062151910.1016/j.radonc.2012.11.00923333011Search in Google Scholar

7Pinkawa M, Klotz J, Djukic V, Schubert C, Escobar-Corral N, Caffaro M, et al. Learning curve in the application of a hydrogel spacer to protect the rectal wall during radiotherapy of localized prostate cancer. Urology 2013; 82: 963-8.PinkawaMKlotzJDjukicVSchubertCEscobar-CorralNCaffaroMLearning curve in the application of a hydrogel spacer to protect the rectal wall during radiotherapy of localized prostate cancerUrology201382963810.1016/j.urology.2013.07.01424074991Search in Google Scholar

8Song DY, Herfarth KK, Uhl M, Eble MJ, Pinkawa M, van Triest B, 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 2013; 87: 81-7.SongDYHerfarthKKUhlMEbleMJPinkawaMvan TriestBA multi-institutional clinical trial of rectal dose reduction via injected polyethylene-glycol hydrogel during intensity modulated radiation therapy for prostate cancer: analysis of dosimetric outcomesInt J Radiat Oncol Biol Phys20138781710.1016/j.ijrobp.2012.12.019373726723414766Search in Google Scholar

9Pinkawa M, Piroth MD, Holy R, Escobar-Corral N, Caffaro M, Djukic V, et al. Quality of life after intensity-modulated radiotherapy for prostate cancer with a hydrogel spacer. Matched-pair analysis. Strahlenther Onkol 2012; 188: 917-25.PinkawaMPirothMDHolyREscobar-CorralNCaffaroMDjukicVQuality of life after intensity-modulated radiotherapy for prostate cancer with a hydrogel spacer. Matched-pair analysisStrahlenther Onkol20121889172510.1007/s00066-012-0172-622933033Search in Google Scholar

10Uhl M, Herfarth K, Eble MJ, Pinkawa M, van Triest B, Kalisvaart R, et al. Absorbable hydrogel spacer use in men undergoing prostate cancer radiotherapy: 12 month toxicity and proctoscopy results of a prospective multicenter phase II trial. Radiat Oncol 2014; 9: 96.UhlMHerfarthKEbleMJPinkawaMvan TriestBKalisvaartRAbsorbable hydrogel spacer use in men undergoing prostate cancer radiotherapy: 12 month toxicity and proctoscopy results of a prospective multicenter phase II trialRadiat Oncol201499610.1186/1748-717X-9-96401663024758224Search in Google Scholar

11Klotz T, Mathers MJ, Lazar Y, Gagel B. Use of hydrogel as spacer in Denovier’s space: optimization of IMRT radiotherapy of localized prostate cancer. Urologe A 2013; 52: 1690-97.KlotzTMathersMJLazarYGagelBUse of hydrogel as spacer in Denovier’s space: optimization of IMRT radiotherapy of localized prostate cancerUrologe A20135216909710.1007/s00120-013-3290-6Search in Google Scholar

12Nat ional Cancer Institute. Common terminology criteria for adverse events v.4.0 (CTCAE). 2011. [citated 14 Feb 2016]. Available from: http://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htm.National Cancer Institute. Common terminology criteria for adverse events v.4.0 (CTCAE)2011citated 14 Feb 2016]. Available fromhttp://ctep.cancer.gov/protocolDevelopment/electronic_applications/ctc.htmSearch in Google Scholar

13Beydoun N, Bucci JA, Chin YS, Malouf D, Enari E, Painter SD. First report of transperineal polyethylene glycol hydrogel spacer use to curtail rectal radiation dose after permanent iodine-125 prostate brachytherapy. Brachytherapy 2013; 12: 368-74.BeydounNBucciJAChinYSMaloufDEnariEPainterSDFirst report of transperineal polyethylene glycol hydrogel spacer use to curtail rectal radiation dose after permanent iodine-125 prostate brachytherapyBrachytherapy2013123687410.1016/j.brachy.2013.01.164Search in Google Scholar

14Christodouleas JP, Tang S, Susil RC, McNutt TR, Song DY, Bekelman J, et al. The effect of anterior proton beams in the setting of a prostate-rectum spacer. Med Dosim 2013; 38: 315-9.ChristodouleasJPTangSSusilRCMcNuttTRSongDYBekelmanJThe effect of anterior proton beams in the setting of a prostate-rectum spacerMed Dosim201338315910.1016/j.meddos.2013.03.002Search in Google Scholar

15Habl G, Hatiboglu G, Edler L, Uhl M, Krause S, Roethke M, et al. Ion Prostate Irradiation (IPI) - a pilot study to establish the safety and feasibility of primary hypofractionated irradiation of the prostate with protons and carbon ions in a raster scan technique. BMC Cancer 2014; 14:202.HablGHatibogluGEdlerLUhlMKrauseSRoethkeMIon Prostate Irradiation (IPI) - a pilot study to establish the safety and feasibility of primary hypofractionated irradiation of the prostate with protons and carbon ions in a raster scan techniqueBMC Cancer20141420210.1186/1471-2407-14-202Search in Google Scholar

16Nguyen PL, Devlin PM, Beard CJ, Orio PF, 3rd, O’Leary MP, Wolfsberger LD, 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 2013; 12:77-83.NguyenPLDevlinPMBeardCJOrioPFO’LearyMPWolfsbergerLDHigh-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 literatureBrachytherapy201312778310.1016/j.brachy.2012.03.005Search in Google Scholar

17Rucinski A, Bauer J, Campbell P, Brons S, Unholtz D, Habl G, et al. Preclinical investigations towards the first spacer gel application in prostate cancer treatment during particle therapy at HIT. Radiat Oncol 2013; 8: 134.RucinskiABauerJCampbellPBronsSUnholtzDHablGPreclinical investigations towards the first spacer gel application in prostate cancer treatment during particle therapy at HITRadiat Oncol2013813410.1186/1748-717X-8-134Search in Google Scholar

18Pinkawa M. Spacer application for prostate cancer radiation therapy. Future Oncol 2014; 10:851-64.PinkawaMSpacer application for prostate cancer radiation therapyFuture Oncol2014108516410.2217/fon.13.223Search in Google Scholar

19Ng M, Brown E, Williams A, Chao M, Lawrentschuk N, Chee R. Fiducial markers and spacers in prostate radiotherapy: current applications. BJU Int 2014; 113 (Suppl 2): 13-20.NgMBrownEWilliamsAChaoMLawrentschukNCheeRFiducial markers and spacers in prostate radiotherapy: current applicationsBJU Int2014113 (Suppl 2)132010.1111/bju.12624Search in Google Scholar

20Mal one D, Clark T, Wei N. Ultrasound-guided percutaneous injection, hydrodissection, and fenestration for carpal tunnel syndrome: description of a new technique. J Appl Res 2010; 10: 116-23.MaloneDClarkTWeiNUltrasound-guided percutaneous injection, hydrodissection, and fenestration for carpal tunnel syndrome: description of a new techniqueJ Appl Res20101011623Search in Google Scholar

21Vas avada AR, Singh R, Apple DJ, Trivedi RH, Pandey SK, Werner L. Effect of hydrodissection on intraoperative performance: randomized study. J Cataract Refract Surg 2002; 28: 1623-8.VasavadaARSinghRAppleDJTrivediRHPandeySKWernerLEffect of hydrodissection on intraoperative performance: randomized studyJ Cataract Refract Surg2002281623810.1016/S0886-3350(01)01252-4Search in Google Scholar

22Pinkawa M, Bornemann C, Escobar-Corral N, Piroth MD, Holy R, Eble MJ. Treatment planning after hydrogel injection during radiotherapy of prostate cancer. Strahlenther Onkol 2013; 189:796-800.PinkawaMBornemannCEscobar-CorralNPirothMDHolyREbleMJTreatment planning after hydrogel injection during radiotherapy of prostate cancerStrahlenther Onkol201318979680010.1007/s00066-013-0388-023836063Search in Google Scholar

23Law ton CA, Michalski J, El-Naqa I, Buyyounouski MK, Lee WR, Menard C, 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 2009; 74: 383-7.LawtonCAMichalskiJEl-NaqaIBuyyounouskiMKLeeWRMenardCRTOG GU Radiation oncology specialists reach consensus on pelvic lymph node volumes for high-risk prostate cancerInt J Radiat Oncol Biol Phys200974383710.1016/j.ijrobp.2008.08.002Search in Google Scholar

24Habl G, Uhl M, Hatiboglu G, Ellerbrock M, Debus J, Herfarth K. Hypofractionated radiotherapy of the prostate using carbon ions or protons - acute toxicities of the IPI-study. [German], [Abstract]. 20th Annual Congress of the German Society for Radiation Oncology. Dusseldorf, Germany; Jul 3-6, 2014. Strahlenther Onkol 2014; 190(Suppl 1):136.HablGUhlMHatibogluGEllerbrockMDebusJHerfarthKHypofractionated radiotherapy of the prostate using carbon ions or protons - acute toxicities of the IPI-study. [German], [Abstract]. 20th Annual Congress of the German Society for Radiation Oncology. Dusseldorf, Germany; Jul 3-6, 2014Strahlenther Onkol2014190(Suppl 1)136Search in Google Scholar

25Mariados N, Sylvester J, Shah D, Karsh L, Hudes R, Beyer D, et al. Hydrogel Spacer Prospective Multicenter Randomized Controlled Pivotal Trial: Dosimetric and Clinical Effects of Perirectal Spacer Application in Men Undergoing Prostate Image Guided Intensity Modulated Radiation Therapy. Int J Radiat Oncol Biol Phys 2015; 92: 971-7.MariadosNSylvesterJShahDKarshLHudesRBeyerDHydrogel Spacer Prospective Multicenter Randomized Controlled Pivotal Trial: Dosimetric and Clinical Effects of Perirectal Spacer Application in Men Undergoing Prostate Image Guided Intensity Modulated Radiation TherapyInt J Radiat Oncol Biol Phys201592971710.1016/j.ijrobp.2015.04.030Search in Google Scholar

26Villers A, McNeal JE, Freiha FS, Boccon-Gibod L, Stamey TA. Invasion of Denonvilliers’ fascia in radical prostatectomy specimens. J Urol 1993; 149:793-8.VillersAMcNealJEFreihaFSBoccon-GibodLStameyTAInvasion of Denonvilliers’ fascia in radical prostatectomy specimensJ Urol1993149793810.1016/S0022-5347(17)36209-2Search in Google Scholar

27Vora 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; 68:1053-8.VoraSAWongWWSchildSEEzzellGAHalyardMYAnalysis 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 cancerInt J Radiat Oncol Biol Phys2007681053810.1016/j.ijrobp.2007.01.04317398023Search in Google Scholar

28Zietman AL, Bae K, Slater JD, Shipley WU, Efstathiou JA, Coen JJ, et al. 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; 28:1106-11.ZietmanALBaeKSlaterJDShipleyWUEfstathiouJACoenJJRandomized 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 95-09J Clin Oncol20102811061110.1200/JCO.2009.25.8475283446320124169Search in Google Scholar

29Pinkawa M, Holy R, Piroth MD, Fischedick K, Schaar S, Szekely-Orban D, et al. Consequential late effects after radiotherapy for prostate cancer - a prospective longitudinal quality of life study. Radiat Oncol 2010; 5: 27.PinkawaMHolyRPirothMDFischedickKSchaarSSzekely-OrbanDConsequential late effects after radiotherapy for prostate cancer - a prospective longitudinal quality of life studyRadiat Oncol201052710.1186/1748-717X-5-27285785320377874Search in Google Scholar

30Mok G, Benz E, Vallee JP, Miralbell R, Zilli T. Optimization of radiation therapy techniques for prostate cancer with prostate-rectum spacers: a systematic review. Int J Radiat Oncol Biol Phys 2014; 90:278-88.MokGBenzEValleeJPMiralbellRZilliTOptimization of radiation therapy techniques for prostate cancer with prostate-rectum spacers: a systematic reviewInt J Radiat Oncol Biol Phys2014902788810.1016/j.ijrobp.2014.06.04425304788Search in Google Scholar

31Wolf F, Gaisberger C, Ziegler I, Krenn E, Scherer P, Hruby S, et al. Comparison of two different rectal spacers in prostate cancer external beam radiotherapy in terms of rectal sparing and volume consistency. Radiother Oncol 2015; 116:221-5.WolfFGaisbergerCZieglerIKrennESchererPHrubySComparison of two different rectal spacers in prostate cancer external beam radiotherapy in terms of rectal sparing and volume consistencyRadiother Oncol2015116221510.1016/j.radonc.2015.07.02726232129Search in Google Scholar

32Arcangeli S, Agolli L, Donato V. Retreatment for prostate cancer with stereotactic body radiation therapy (SBRT): Feasible or foolhardy? Rep Pract Oncol Radiother 2015; 20:425-9.ArcangeliSAgolliLDonatoVRetreatment for prostate cancer with stereotactic body radiation therapy (SBRT): Feasible or foolhardy?Rep Pract Oncol Radiother201520425910.1016/j.rpor.2014.08.001466135326696782Search in Google Scholar

33Viswanathan AN, Damato AL, Nguyen PL Novel use of a hydrogel spacer permits reirradiation in otherwise incurable recurrent gynecologic cancers. J Clin Oncol 2013; 31: e446-7.ViswanathanANDamatoALNguyenPLNovel use of a hydrogel spacer permits reirradiation in otherwise incurable recurrent gynecologic cancersJ Clin Oncol201331e446710.1200/JCO.2012.47.9931579566624145342Search in Google Scholar

34Kishi K, Iida T, Ojima T, Sonomura T, Shirai S, Nakai M, et al. Esophageal gel-shifting technique facilitating eradicative boost or reirradiation to upper mediastinal targets of recurrent nerve lymph node without damaging esophagus. J Radiat Res 2013; 54:748-54.KishiKIidaTOjimaTSonomuraTShiraiSNakaiMEsophageal gel-shifting technique facilitating eradicative boost or reirradiation to upper mediastinal targets of recurrent nerve lymph node without damaging esophagusJ Radiat Res2013547485410.1093/jrr/rrs137370966523436229Search in Google Scholar

35Bachmann R, Heinzelmann F, Muller AC, Ladurner R, Schneider CC, Konigsrainer A, et al. Laparoscopic pelvic mesh placement with closure of pelvic floor entrance to prevent small intestine radiation trauma - A retrospective cohort analysis. Int J Surg 2015; 23: 62-7.BachmannRHeinzelmannFMullerACLadurnerRSchneiderCCKonigsrainerALaparoscopic pelvic mesh placement with closure of pelvic floor entrance to prevent small intestine radiation trauma - A retrospective cohort analysisInt J Surg20152362710.1016/j.ijsu.2015.08.08226369863Search in Google Scholar