Illustration of SpaceOAR Hydrogel

Clinical Summary

Early Tolerance and Tumor Control Outcomes with High-Dose Ultrahypofractionated Radiation Therapy for Prostate Cancer


By: Zelefsky MJ, Pinitpatcharalert A, Kollmeier M, et al.

In a retrospective analysis entitled Early Tolerance and Tumor Control Outcomes with High-Dose Ultrahypofractionated Radiation Therapy for Prostate Cancer, a total of 551 prostate cancer patients received dose-escalated SBRT (40 Gy over 5 fractions). 269 of the 551 patients received a hydrogel spacer.

Percentage of Late Toxicities with and without SpaceOAR™ Hydrogel 

Gastrointestinal: SpaceOAR 1%, No SpaceOAR 6%. Genitourinary: SpaceOAR 15%, No SpaceOAR 32%


“The use of a hydrogel rectal spacer was significantly associated with reduced late GI toxicity and lower odds of developing late GU toxicity”.


Link to full article >





Limitations of this report include:
 
  • Study was retrospective in nature
  • The SpaceOAR™ Hydrogel pivotal study did not use SBRT so the results may not be comparable
  • Short follow-up time and additional events could alter the conclusions
  • Study was not designed or powered to make definitive claims about rectal spacer benefit
  • These results may not be achieved with other SBRT protocols
  • Rectal spacer placement was ubiquitous after 2016 unless contraindicated – data may be confounded by an underlying effect of time period.


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References
  1. Zelefsky MJ, Pinitpatcharalert A, Kollmeier M, et al. Early Tolerance and Tumor Control Outcomes with High-dose Ultrahypofractionated Radiation Therapy for Prostate Cancer. Eur Urol Oncol. 2019;S2588-9311(19)30147-6.
Disclaimers

SBRT 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.

The content of this article/publication is under the sole responsibility of its author/publisher and does not represent the opinion of BSC.

Caution: U.S. Federal law restricts this device to sale by or on the order of a physician.

CAUTION: The law restricts these devices to sale by or on the order of a physician. Indications, contraindications, warnings and instructions for use can be found in the product labeling supplied with each device. Information for use only in countries with applicable health authority registrations. This material not intended for use in France.

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