
- Study was retrospective in nature.
- The SpaceOAR™ Hydrogel pivotal study did not use PBT 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 PBT protocols.
- A limitation of these data is the high drop-out rate in reporting with followup, though the rates are roughly similar between cohorts. A patient-level analysis of EPIC scores was not possible due to the limited number of patients with scores at all time points.
- Incidences of RB were retrospectively graded, and thus subject to availability and heterogeneity of records.
- High-risk patients comprised a higher proportion in the rectal balloon immobilization group, in large part because patients with ECE, SVI, or local invasion were precluded from receiving hydrogel spacer.
Frequently Asked Questions
We've got the answers.
Get SpaceOAR Hydrogel
Become a certified applier.
Sign Up
Get exclusive updates and clincial data.
- Dinh TKT, Lee Jr HJ, Macomber MW, et al. Rectal hydrogel spacer improves late gastrointestinal toxicity compared to rectal balloon immobilization after proton beam radiation therapy for localized prostate cancer: a retrospective observational study. Int J Radiat Oncol Biol Phys. 2020 Nov 1;108(3):635-43.
PBT 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.
Products shown for INFORMATION purposes only and may not be approved or for sale in certain countries. Please check availability with your local sales representative or customer service.
All images are the property of Boston Scientific. All trademarks are the property of their respective owners.