Next-Generation Prostate Cancer Radiotherapy
SpaceOAR hydrogel is the first absorbable hydrogel spacer designed to reduce unintentional rectal injury in men undergoing prostate radiotherapy (RT). Using ultrasound guidance, the hydrogel is administered as a liquid that expands the space between Denonvilliers’ fascia and the rectal wall, where it solidifies into a soft, but firm, hydrogel within 10 seconds. The hydrogel remains in place for 3 months during prostate radiotherapy, after which it liquefies by hydrolysis, and is absorbed and cleared in the patient’s urine.
Learn Why Radiation Oncologists & Urologists are Using SpaceOAR Hydrogel
Clinical Trial Patient, MRI Images
In order to assess SpaceOAR hydrogel safety and effectiveness a prospective, randomized, controlled, patient-blinded clinical study was performed. In 20 centers a total of 222 men were randomized to receive fiducial marker and SpaceOAR hydrogel injection, or fiducial markers alone (control group). Patients then received 79.2Gy x 44 fraction IG-IMRT, and were followed weekly during RT, and at 3, 6, 12 and 15 months.
SpaceOAR Hydrogel Clinical Trial Results
|Prostate-Rectal Space||Pre-implant: 1.6 mm
Post-implant: 12.6 mm
|Procedure Success||99% Technical Success (gel present)|
|Rectal V70 Dose
|Pre-SpaceOAR Hydrogel: 12.4%
Post-SpaceOAR Hydrogel: 3.3%
|Acute Rectal Pain AE’s
|Control Group: 11.1%
SpaceOAR Hydrogel Group: 2.7%
|Late Rectal Toxicity
(1 year post RT)
|Control Group: 7% (Max G3*)
SpaceOAR Hydrogel Group: 2% (Max G1)
|Bowel QOL (EPIC)
% Patients with >10pt decline (15 mo)
|Control Group: 21.4%
SpaceOAR Hydrogel Group: 11.6%
Grade 1 (G1): Mild, transient
Grade 2 (G2):Moderate, requiring prescription medication
Grade 3 (G3): Additional procedure required for treatment
Please see Instructions for Use for a complete list of potential risks, warnings and precautions.
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