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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).1 269 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% bar chart.

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

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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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SpaceOAR System Indications, Safety, and Warnings
SpaceOAR Vue Indications, Safety, and Warnings

Reference

  1. Zelefsky MJ, Pinitpatcharalert A, Kollmeier, et al. Early tolerance and tumor control outcomes with high-dose ultrahypofractionated radiation therapy for prostate cancer. Eur Urol Oncol. 2020 Dec;3(6):748–55.

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 labelling supplied with each device or at www.IFU-BSCI.com. Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. This material not intended for use in France.

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