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Clinical Summary

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).

Dosimetric outcomes

Conventional fractionation (78 Gy/39 fractions)
  Pts rV75 rV70 rV60 rV50
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)
  Pts rV65 rV63 rV60 rV50
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)
Abbreviations: IMRT = intensity modulated radiation therapy; (P + SV) = prostate plus seminal vesicles;
(P + SV + Lns) = prostate plus seminal vesicles plus lymph nodes; PT = proton therapy; Pts = patients.
“Hydrogel placement is feasible in large glands >80cc, even when including a subgroup of patients with prostates >100cc (100.1-186.6 cc) with very favorable dosimetric outcomes which are in line with benchmark published results with smaller glands.”


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Limitations of this report include:
 
  • 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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References
  1. 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.
Disclaimers

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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