The use of SpaceOAR hydrogel in dose-escalated prostate cancer radiotherapy and its impact on rectal dosimetry

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1 The use of SpaceOAR hydrogel in dose-escalated prostate cancer radiotherapy and its impact on rectal dosimetry Poster No.: R-0296 Congress: Type: Authors: Keywords: DOI: 2014 CSM Scientific Exhibit F. Alfieri, K. van Gysen, T. Eade, A. Kneebone; WORLD SQUARE/AU Pelvis, MR, CT, Intensity Modulated Radiotherapy (IMRT), Radiation therapy / Oncology, Cancer, Dosimetric comparison, Radiotherapy techniques /ranzcr2014/R-0296 Any information contained in this pdf file is automatically generated from digital material submitted to EPOS by third parties in the form of scientific presentations. References to any names, marks, products, or services of third parties or hypertext links to thirdparty sites or information are provided solely as a convenience to you and do not in any way constitute or imply RANZCR/AIR/ACPSEM's endorsement, sponsorship or recommendation of the third party, information, product or service. RANZCR/AIR/ ACPSEM is not responsible for the content of these pages and does not make any representations regarding the content or accuracy of material in this file. As per copyright regulations, any unauthorised use of the material or parts thereof as well as commercial reproduction or multiple distribution by any traditional or electronically based reproduction/publication method ist strictly prohibited. You agree to defend, indemnify, and hold RANZCR/AIR/ACPSEM harmless from and against any and all claims, damages, costs, and expenses, including attorneys' fees, arising from or related to your use of these pages. Please note: Links to movies,.ppt slideshows,.doc documents and any other multimedia files are not available in the pdf version of presentations. Page 1 of 11

2 Aim Dose escalation can be beneficial in prostate cancer radiotherapy but is limited by the anterior rectal wall sitting adjacent to the prostate. (1-5) SpaceOAR TM hydrogel is a material injected between the rectum and prostate to create a temporary gap between the two structures (Figure 1). This offers the potential to reduce rectal dose without compromising dose to the prostate. Fig. 1: Hydrogel as a prostate/rectum spacer. References: Augmenix, Inc The feasibility and dosimetric benefit of a temporary spacer between the rectum and the prostate for prostate IMRT was investigated in this study. Methods and materials An ethics approved prospective phase I/II study was undertaken at the Northern Sydney Cancer Centre and enrolled 30 patients. Page 2 of 11

3 After informed consent, 10cc of SpaceOAR hydrogel was injected under general anaesthetic using a transperineal approach. Patients were CT/MRI simulated before and after injection of hydrogel. The first 10 patients had another MRI at completion of RT to assess hydrogel durability. All patients were planned using an IMRT technique on both pre- and posthydrogel scans to a PTV D95 of 80Gy/40#. PTV was CTV + 7mm expansion except post where a 5mm expansion was used. Primary endpoints were perioperative toxicity and rectal dosimetry. The rectal dosimetry endpoints of V80, V75, V70, V65, V40 and V30 were analysed. Results Perioperative Toxicity Hydrogel has been shown to be a safe and well tolerated prostate/rectum spacer. (6) In this study, the procedure was successfully performed in 29/30 patients. No patients reported bleeding or infection following the procedure. Gel was injected into the rectal lumen in 1 patient. No rectal side effects have been reported by the patient at 12 months follow-up. The position of the gel in the rectal lumen for this patient was identified on MRI (Figure 2) and was not clearly visualised in the planning CT (Figure 3). The interface between the rectum and hydrogel were not always clearly definable on CT but was more visible on MRI. Page 3 of 11

4 Fig. 2: T2 MRI showing hydrogel (outlined in orange) in the rectal lumen. References: Northern Sydney Cancer Centre, Royal North Shore Hospital - WORLD SQUARE/AU Page 4 of 11

5 Fig. 3: CT at the same axial level as figure 2. The hydrogel is indistinguishable from rectal tissue. References: Northern Sydney Cancer Centre, Royal North Shore Hospital - WORLD SQUARE/AU Target Coverage and Rectal Dose For all plans 95% of the PTV received 100% of TD. There was no significant difference in mean dose to the PTV HD pre- and post-hydrogel (82.4Gy vs. 82.3Gy). Rectal doses were significantly lower in all patients after hydrogel for all dose endpoints (Figure 4). Page 5 of 11

6 Fig. 4: Bar graph comparing the dose received to the rectum pre- and post-hydrogel insertion. References: Northern Sydney Cancer Centre, Royal North Shore Hospital - WORLD SQUARE/AU High doses (>70Gy) to the rectum have been shown to predict for a higher risk of later toxicity. (7) The mean volume of the rectum receiving 70Gy was substantially higher prior to hydrogel (12.3%) compared to after hydrogel (3.7%). Similar improvements to the rectal V70Gy dose with the use of hydrogel have been reported previously. (6) Hydrogel Durability Hydrogel is gradually reabsorbed in the body and excreted via renal filtration 3-6 months after insertion. Hydrogel has been shown to last for the duration of treatment. (8) Early absorption of the gel was seen in 3 patients on the post treatment MRI (n=10), although separation of the prostate and rectum was still > 1cm. Page 6 of 11

7 Images for this section: Fig. 2: T2 MRI showing hydrogel (outlined in orange) in the rectal lumen. Page 7 of 11

8 Fig. 3: CT at the same axial level as figure 2. The hydrogel is indistinguishable from rectal tissue. Page 8 of 11

9 Fig. 4: Bar graph comparing the dose received to the rectum pre- and post-hydrogel insertion. Page 9 of 11

10 Conclusion SpaceOAR TM hydrogel was successfully injected in 29/30 patients with minimal side effects. Hydrogel was able to provide a consistent separation between the rectum and prostate for the duration of a 40 fraction course of prostate radiotherapy. Hydrogel allows for a reduction in rectal dose without compromising target dose coverage. The dosimetric benefits of hydrogel were greater for higher rectal doses (V65 to V80), although lower range rectal doses (V30-V40) were also improved. The use of MRI in planning to assist in hydrogel and rectal delineation is recommended as hydrogel can be poorly defined on CT. Hydrogel may provide benefit for other dose escalation techniques such as SABR and SIB. Personal information References 1. Pollack A, Zagars GK, Starkschall G, Antolak JA, Lee JJ, Huang E, et al. Prostate cancer radiation dose response: results of the M. D. Anderson phase III randomized trial. Int J Radiat Oncol Biol Phys. 2002;53: Eade TN, Hanlon AL, Horwitz EM, Buyyounouski MK, Hanks GE, Pollack A. What dose of external-beam radiation is high enough for prostate cancer? Int J Radiat Oncol Biol Phys. 2007;68: Peeters ST, Heemsbergen WD, Koper PC, van Putten WL, Slot A, Dielwart MF, et al. Dose-response in radiotherapy for localized prostate cancer: results of the Dutch multicenter randomized phase III trial comparing 68 Gy of radiotherapy with 78 Gy. J Clin Oncol. 2006;24: Beckendorf V, Guerif S, Le Prise E, Cosset JM, Bougnoux A, Chauvet B, et al. 70 Gy Versus 80 Gy in Localized Prostate Cancer: 5-Year Results of GETUG 06 Randomized Trial. Int J Radiat Oncol Biol Phys. 2011;80: Pollack A, Hanlon AL, Horwitz EM, Feigenberg SJ, Konski AA, Movsas B, et al. Dosimetry and preliminary acute toxicity in the first 100 men treated for prostate cancer on a randomized hypofractionation dose escalation trial. Int J Radiat Oncol Biol Phys. 2006;64: Page 10 of 11

11 6. Hatiboglu G, Pinkawa M, Vallée, Hadaschik B, Hohenfellner, M. Application technique: placement of a prostate - rectum spacer in men undergoing prostate radiation therapy. BJU Int. 2012;E647-E 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 2002;54: Pinkawa 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: Page 11 of 11

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