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    Interventional procedure overview of biodegradable spacer insertion to reduce rectal toxicity during radiotherapy for prostate cancer

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    References

    1. Mariados N, Sylvester J et al (2015). 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. International Journal of Radiation Oncology Biology Physics.92 (5) 971-977.

    Hamstra da, Mariados N, Sylvester J et al (2017). Continued Benefit to Rectal Separation for Prostate Radiation Therapy: Final Results of a Phase III Trial. Radiation Oncology International Journal of biology physics. 9 (5) 67-985.

    Hamstra DA, Mariados N, Sylvester J, et al.(2018) Sexual quality of life following prostate intensity modulated radiation therapy (IMRT) with a rectal/prostate spacer: secondary analysis of a phase 3 trial. Pract Radiat Oncol. 8(1):e7-e15.

    Karsh LI, Gross ET, Pieczonka CM, et al. (2018) Absorbable hydrogel spacer use in prostate radiotherapy: a comprehensive review of phase 3 clinical trial published data. Urology.115:39-44.

    1. Miller LE, Efstathiou JA, Bhattacharyya SK et al. (2020) Association of the Placement of a Perirectal Hydrogel Spacer with the Clinical Outcomes of Men Receiving Radiotherapy for Prostate Cancer: A Systematic Review and Meta-analysis. JAMA Network Open. 3(6):e208221-e

    2. Norwegian Institute of Public Health (NIPHNO), National School of Public Health, Management and Professional Development (NSPHMPDB); et al. Biodegradable rectum spacers to reduce toxicity for prostate cancer. Collaborative Assessment. Oslo, Norway: EUnetHTA; 2020. Report No.: OTCA23.

    3. Armstrong N, Bahl A, Pinkawa M, et al. (2021) SpaceOAR Hydrogel spacer for reducing radiation toxicity during radiotherapy for prostate cancer. A systematic review, Urology, doi: https://doi.org/10.1016/j.urology.2021.05.013

    4. Vaggers S, Rai BP, Chedgy ECP et al. (2021) Polyethylene glycol‑based hydrogel rectal spacers for prostate brachytherapy: a systematic review with a focus on technique. World Journal of Urology 39:1769–1780.

    5. Mok G, Benz E, Vallee JP et al. (2014) Optimization of radiation therapy techniques for prostate cancer with prostate-rectum spacers: a systematic review. Int J Radiat Oncol Biol Phys. 90(2):278-288.

    6. Ardekani MA, Ghaffari H, Navaser M et al. (2021) Effectiveness of rectal displacement devices in managing prostate motion: a systematic review. Strahlenther Onkol,197:97–115

    7. Aminsharifi A, Kotamarti S, Silver D et al. (2019) Major complications and adverse events related to the injection of the SpaceOAR hydrogel system before radiotherapy for prostate cancer: Review of the manufacturer and user facility device experience database. J Endourol. 33(10):868-871.

    8. Hall WA, Tree AC, Dearnaley D et al. (2021). Considering benefit and risk before routinely recommending SpaceOAR. The lancet oncology. 22 (1), 11-13.

    9. Chapet O, Decullier E et al (2015). Prostate hypofractionated radiation therapy with injection of hyaluronic acid: Acute toxicities in a phase 2 study. International Journal of Radiation Oncology Biology Physics.91 (4) 730-736.

    10. Institut national d'excellence en santé et en services sociaux (INESSS). Utilisation de l'hydrogel SpaceOARMD comme espace rectal lors de la radiothérapie de la prostate. Avis rédigé par Cathy Gosselin, Andréa Senay, Amélie Rousseau et Vanessa Dufour. Québec, Qc : INESSS; 2021. 200 p

    11. Chao YS, MacDougall D, de Nanassy A. (2019) Hydrogel spacers for patients with prostate cancer: a review of clinical effectiveness and cost-effectiveness. Ottawa: CADTH; Feb. (CADTH rapid response report: summary with critical appraisal).

    12. Chung P, Brown J, D'Souza D, Koll W, Morgan S, SPACER RRG. Cancer Care Ontario: biodegradable rectal spacers for prostate cancer radiotherapy. (Program in Evidence-based Care recommendation report no.: 21-5). Toronto (ON): Cancer Care Ontario; 2019 Jan 16: https://www.cancercareontario.ca/sites/ccocancercare/files/guidelines/full/pebc21-5f.pdf . Accessed 2021 September 29.

    13. National Comprehensive Cancer Network. NCCN Guidelines: prostate cancer v. 4.2018. Plymouth Meeting (PA): National Comprehensive Cancer Network; 2018. Accessed 2021 September 29.

    14. SpaceOAR System (Augmenix, Inc.) Hydrogel Spacer for Reducing Exposure during Prostate Cancer Radiation Therapy. Product brief. ECRI Institute Health Technology Assessment Information Service, May 2017. Accessed 2021 September 29.

    15. Babayan RK, Steinberg ML, Miller LE. Re: Aminsharifi et al. (2020) Major complications and adverse events related to the injection of the SpaceOAR hydrogel system before radiotherapy for prostate cancer: review of the manufacturer and user facility device experience database. J Endourol; 34: 240–41.