Spacer application was well tolerated. Increased perirectal space reduced rectal irradiation, reduced rectal toxicity severity, and decreased rates of patients experiencing declines in bowel quality of life. The spacer appears to be an effective tool, potentially enabling advanced prostate RT protocols.

The benefit of a hydrogel spacer in reducing the rectal dose, toxicity, and QOL declines after image guided intensity modulated radiation therapy for prostate cancer was maintained or increased with a longer follow-up period, providing stronger evidence for the benefit of hydrogel spacer use in prostate radiation therapy.

The use of a hydrogel spacer decreased dose to the penile bulb, which was associated with improved erectile function compared with the control group based on patient-reported sexual QOL.

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Previously a phase III trial of a hydrogel rectal spacer during prostate radiation therapy found decreased toxicity and a clinically significant improvement in bowel quality of life (QOL) at 3 years by the Expanded Prostate Cancer Index. We performed a secondary analysis to identify men less likely to benefit. Sources of support: This work was supported by research funding from Augmenix, Inc, which is now a wholly owned subsidiary of Boston Scientific. Disclosures: N. Mariados and D. Shah have each made small investments in Augmenix. D.A. Hamstra, J. Michalski, and S. Daignault-Newton have provided paid consulting services for Augmenix and Boston Scientific. J. Michalski, H.A. Gay, and W. Bosch have provided core laboratory services for Augmenix.

Background: Our study was designed to determine bone mineral density (BMD) in patients beginning hemodialysis (HD) treatment, a possible correlation with the duration of renal failure prior to treatment, a possible correlation with the basic disease and the association with the concentration of intact parathormone (iPTH). Methods: Our prospective clinical trial included 50 patients beginning HD treatment. Cortical bone mineral density (BMDc) was measured at the left femoral neck and trabecular bone mineral density (BMDt) in the region of the lumbosacral spine. Bone mineral density (BMD) was measured by quantitative digital radiography using a Hologic 2000 plus device belonging to the third generation of densitometers based on dual-energy X-ray absorptiometry. Results: In patients (PTS) beginning HD, the average BMDc was 82 ± 15% of BMDc in a healthy population of corresponding age and sex. The average BMDt was 91 ± 16% of BMDt in a healthy population of corresponding age and sex. The difference was statistically significant (p < 0.05). There is a negative correlation between iPTH and BMDc r = –0.34 (p < 0.02). Patients with chronic glomerulonephritis (GN) had a statistically significantly higher BMDc (g/cm²) (p < 0.01) than those with analgetic nephropathy (AN). PTS with AN have lower BMDc (g/cm², %) (p < 0.02) and BMDt (p < 0.005) than the rest of the PTS, iPTH in PTS with AN is higher than in the rest of the PTS (p < 0.05). Conclusions: In PTS at the beginning of HD, BMD is lower than in healthy people of corresponding age and sex. This means that BMD already decreases prior to HD. BMDc was statistically significantly lower than BMDt (p < 0.00005). PTS with AN have lower BMD than those with GN and all remaining PTS. A negative correlation between iPTH and BMDc was found.

69 Background: The SpaceOAR phase 3 trial showed that a hydrogel spacer between the prostate and rectum decreased rectal dose and toxicity while improving bowel quality of life (QOL) after image guided prostate IMRT to 79.2 Gy. Here we evaluated dose to penile bulb as well as sexual function on this trial Methods: Sexual QOL was measured with the Expanded Prostate Cancer Index Composite (EPIC) by mean summary scores and the proportion of patients with a minimally important decline (MID) (11 points). Stratification was based on severe erectile dysfunction (ED)(EPIC < = 60) vs not. The single question on “Erections sufficient for intercourse over the preceding 4 weeks” was also evaluated. Results: Median Follow-up was 37 months with 63% of men evaluable at 3 years. With spacer the dose to the penile bulb was reduced for mean (21 vs 11 Gy), Dmax (46 vs 36 Gy), and V10-V30 (all p < 0.05). Baseline sexual function was 53 (±24) with 54% having severe ED with no difference between arms (p > 0.1). At 3 years average EPIC score was 39.7 (± 23) and 82% had severe ED with no differences between arms (p > 0.1). At enrollment 42% had EPIC > 60 with average summary of 77 (±8.3) which at 3 years was 53 (±24.8). In this sub-group at 3 years a higher EPIC was observed on the Spacer arm (57.7 (±24.1) vs. 44.6 (± 24.4)) which met the threshold for an MID without statistical significance (p = 0.07). Based on MID and twice that there was a trend favoring Spacer with 53% vs 75% for 11-point decline (p = 0.064) and 41% vs 60% for 22 point decline (p = 0.11). A small number of these men were potent at baseline and evaluable both at baseline and 3 years (n = 49). Of these 37.5% in the Control arm had erections sufficient for intercourse at 3 years as compared to 66.7% (p = 0.07) in the Spacer arm. Power analysis revealed 35% power to detect a change of 11 points between arms and 27% power to detect a difference of 22 points. Conclusions: The use of a hydrogel spacer decreased dose to the penile bulb with a suggestion of a clinically significant improvement in patient reported sexual function and potency. These did not achieve statistical significance potentially due to the high prevalence of ED at baseline and, therefore, the small evaluable sample size. Analysis of penile bulb dose and QOL is ongoing. Clinical trial information: NCT01538628.

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