A pivot clinical trial utilizing hydrogel spacer was conducted in 2010-2011, enrolling 114 patients received external beam radiation therapy to the prostate1. There were 54 patients selected for a hydrogel injection before the beginning of radiation therapy. Patients were surveyed before radiation therapy, at the last day of radiation therapy, and a median time of 2 months, 17 months, and 63 months after radiation therapy using a validated questionnaire (Expanded Prostate Cancer Index Composite). A mean score change of >5 points was defined as clinically relevant. Among patients treated with a hydrogel spacer, mean bowel function and bother score changes of >5 points in comparison with baseline levels were found only at the end of radiation therapy (10-15 points; p < 0.01). Mean bother score changes of 21 points at the end of radiation therapy, 8 points at 2 months, 7 points at 17 months, and 6 points at 63 months after radiation therapy were found for patients treated without a spacer. These quality of life results have given hydrogel spacers an option among patients considering radiation therapy.
Dr. Sprenkle then showed several videos demonstrating placement of the SpaceOAR® hydrogel rectal spacer. Briefly, his steps include the following:
- Preparation of the patient with a betadine prep, as well as a lidocaine cream for topical anesthesia
- Transrectal placement of the mounted ultrasound probe, taking care to be able to see the entire prostate to the level of the seminal vesicles in both the transverse and sagittal planes
- A local block is then performed on either side of the midline and deep to anesthetize the bilateral neurovascular bundles
- If needed, fiducial markers are placed in a transperineal fashion prior to hydrogel spacer placement
- Midline placement of the needle taking care to stay between the space created by the rectal wall and Denonvillier’s fascia. To do this it is useful to guide the needle in the sagittal plane, taking care to always visualize the needle with the bevel down.
- Once at the midgland level of the prostate, there is a white rectal fat plane that is then test hydrodissected with saline. This is confirmed in both the transverse and sagittal planes
- The needle is left in place and the backbench prepared hydrogel spacer is connected to the needle
- SpaceOAR is injected over 10-12 seconds without stopping in order to allow filling of the previously hydrodissected space.
Presented by: Preston C. Sprenkle, Yale University School of Medicine, New Haven, CT
Written By: Zachary Klaassen, MD, MSc – Assistant Professor of Urology, Georgia Cancer Center, Augusta University - Medical College of Georgia @zklaassen_md at American Urological Association's 2019 Annual Meeting (AUA 2019), May 3 – 6, 2019 in Chicago, Illinois
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