Clinical summary

SABRE Trial

The SABRE Trial is the first global, clinical trial to evaluate the effectiveness of SpaceOAR Vue™ Hydrogel in prostate cancer patients receiving SBRT. SpaceOAR Vue, the next-generation radiopaque hydrogel, is designed to reduce the radiation dose to the rectum, thus minimizing the impact on patients’ urinary, sexual and bowel functions.¹

What does SABRE stand for?

Effectiveness of the SpaceOAR Vue System in subjects with prostate cancer being treated with Stereotactic Body Radiotherapy

Study objective

Demonstrate the effectiveness of SpaceOAR Vue Hydrogel in reducing late gastrointestinal (GI) toxicity in patients receiving SBRT for the treatment of prostate cancer.

Primary endpoint:

Proportion of patients experiencing late GI toxicity between 3 and 24 months after SBRT with or without placement of SpaceOAR Vue Hydrogel.

Secondary endpoint:

Proportion of patients experiencing a decrease in Expanded Prostate Cancer Index Composite (EPIC-26) bowel score greater than or equal to the minimal important difference (MID) in EPIC-26 bowel score from baseline to 24 months post-SBRT initiation.

Please visit clinicaltrials.gov or email Boston Scientific at SABREStudy@bsci.com to learn more.

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SpaceOAR System Indications, Safety, and Warnings

SpaceOAR Vue Indications, Safety, and Warnings

Reference

Data on file with Boston Scientific.

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.

SpaceOAR and SpaceOAR Vue Hydrogels are intended to temporarily position the anterior rectal wall away from the prostate during radiotherapy for prostate cancer and in creating this space it is the intent of SpaceOAR and SpaceOAR Vue Hydrogels to reduce the radiation dose delivered to the anterior rectum.

SpaceOAR and SpaceOAR Vue Hydrogels contain polyethylene glycol (PEG). SpaceOAR Vue Hydrogel contains iodine.

Prior to using these devices, please review the Instructions for Use for a complete listing of indications, contraindications, warnings, precautions and potential adverse events.

As with any medical treatment, there are some risks involved with the use of SpaceOAR and SpaceOAR Vue Hydrogels. Potential complications associated with SpaceOAR and SpaceOAR Vue Hydrogels include, but are not limited to: pain associated with SpaceOAR and SpaceOAR Vue Hydrogels injection, pain or discomfort associated with SpaceOAR and SpaceOAR Vue Hydrogels, local inflammatory reactions, infection (including abscess), urinary retention, urgency, constipation (acute, chronic, or secondary to outlet perforation), rectal tenesmus/muscle spasm, mucosal damage, ulcers, fistula, perforation (including prostate, bladder, urethra, rectum), necrosis, allergic reaction (localized or more severe reaction, such as anaphylaxis), embolism (venous or arterial embolism is possible and may present outside of the pelvis, potentially impacting vital organs or extremities), syncope and bleeding. The occurrence of one or more of these complications may require treatment or surgical intervention. URO-989811-AB.

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