Expanding the Utilization of Rectal Spacer Hydrogel for Larger Prostate Glands (>80cc): Feasibility and Dosimetric Outcomes
By: Fagundes M, Rodrigues MA, Olszewski S, et al.
33 patients with localized prostate cancer with glands exceeding 80cc were treated at a single institution using intensity-modulated radiotherapy (IMRT, n=15) and proton therapy (n=18) from 2017 to 2019. 16 patients received conventional fractionation and 17 received hypofractionation. Previous prospective multi-institutional studies only included prostates <80cc.1 The mean separation was 9.9 mm (range, 6.6 - 19.4 mm) for glands measuring >80 to 100 cm3 and 8.8 mm (range, 4.7 - 12.3 mm) for glands >100 cm3 . Patients were assessed weekly using common terminology criteria for adverse events (CTCAE).
|Conventional fractionation (78 Gy/39 fractions)|
|All||16||0.84% (0-2.7)||2.25% (0-4.7)||5.61% (1.7-9.5)||10.5% (2.39-15.2)|
|P + SV||4||0.75% (0.06-1.77)||2% (0.75-4.4)||5.47% (2.5-9.5)||10.1% (6.4-15.2)|
|P + SV + Lns||12||0.87% (0-2.7%)||2.3% (0-4.7)||5.66% (1.7-8.9)||10.7% (2.3-14.9)|
|P + SV (IMRT)||2||0.58% (0.06-1.1)||1.61% (0.93-2.3)||4.95% (4.5-5.4)||9.45% (9.4-9.5)|
|P + SV (PT)||2||0.93% (0.09-1.77)||2.57% (0.75-4.4)||6% (2.5-9.5)||10.8% (6.4-15.2)|
|Moderate hypofractionation (70 Gy/28 fractions)|
|All P + SV||17||1.67% (0-5.8)||2.3% (0.1-6.7)||3.4% (0.4-9.6)||8.6% (3.3-15.7)|
|P + SV (IMRT)||9||1.16% (0-4.6)||1.65% (0.1-5.8)||2.5% (0.3-7.8)||6.9% (2.46-15)|
|P + SV (PT)||8||2.24% (0.7-5.8)||3.1% (1.3-6.7)||4.48% (2.4-9.6)||10.5% (4.9-15.7)|
(P + SV + Lns) = prostate plus seminal vesicles plus lymph nodes; PT = proton therapy; Pts = patients.
- Study was retrospective in nature
- The SpaceOAR Hydrogel pivotal study did not evaluate glands >80cc so the results may not be comparable
- This study was not designed or powered to make definitive claims about the benefits of a spacer
- These results may not be achieved with other large gland protocols
- The pivotal study done for SpaceOAR Hydrogel utilized fractionation schedules of 79.2Gy over 44 fractions
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- Mariados N, Sylvester J, Shah 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(5):971-977.
78Gy over 39 fractions was not the method used in the SpaceOAR™ Hydrogel single-blind Phase III trial performed to evaluate dosimetric and clinical effects of SpaceOAR Hydrogel. IG-IMRT delivered at 79.2 Gy in 1.8-Gy fractions was the method used.
Results from case studies are not necessarily predictive of results in other cases. Results in other cases may vary.
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