Systematic searches of Medline, Embase, and the Cochrane Center Register of Controlled Trials for studies in men who received the SpaceOAR hydrogel spacer prior to SBRT (>5.0 Gy fractions) for localized prostate cancer were performed.
In 11 studies with 780 patients, SBRT protocols ranged from 7 to 10 Gy per fraction with total dose ranging from 19 to 45 Gy. Perirectal distance achieved with the rectal spacer ranged from 9.6 to 14.5 mm (median 10.8 mm). Compared to controls receiving no spacer, SpaceOAR placement reduced the radiation delivered to the rectum by 29% to 56% across a dosimetric profile curve.
Early follow-up found grade 2 GI complications were reported in 7.0% of patients and no early grade 3+ GI complications were reported. Over 16 months median follow-up, freedom from biochemical failure ranged from 96.4% to 100%.
Table 3 – Summary of key outcomes in studies of stereotactic body radiation therapy and rectal hydrogel spacer for treatment of prostate cancer.
FFBF = freedom from biochemical failure
*Brackets denote estimated values.
Results from case studies are not necessarily predictive of results in other cases. Results in other cases may vary.
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