Eligible patients included low/intermediate risk prostate cancer cT1-2, N0 M0, Gl 6-7, PSA <20 with an IPSS 12. Intermediate risk patients received up to six mo. of ADT. IPSS scores were obtained prior to treatment, last week of treatment at 6 wks., 3 mo. and then every 6 mo.; EPIC-SF12/Max-PC prior to treatment 6 wks., 3 mo. and then every 6 mo. Toxicity (CTCAE4.0) at baseline, weekly during treatment, 6 wks., 3 mo. and then every 6 mo. Cumulative incidence estimation was used to calculate toxicity incidence rate and Mann-Whitney test was used to compare QOL scores between two arms. All p-values were two-sided. Results: As of January 2017, 54 pts had completed treatment, with 11.5 mo. median follow-up (mean 17.2). A total of 70% of the patients were intermediate risk. Patients were evenly distributed by age, Gleason score, t stage, risk group, race, and ADT use. Between the two arms there was no difference in the cumulative incident of grade 2+ GU toxicity (PZ0.97) or GI toxicity (PZ0.181). Fifteen mo. rates were 19%v 12% GU, and 12% v 0% GI. One grade 3 toxicity (EHRT) was observed. There was no significant difference in EPIC-SF12 or Max-PC scores at any time point between the 2 arms in sum score or change from baseline. For IPSS there were statistically significant differences at 6wks (pZ0.0049), 9mo (pZ0.0009), 15mo (pZ0.0076) in favor of AHRT (lower IPSS score). Conclusion: There were no differences in early GI and GU toxicities or PRO measures between AHRT and EHRT. This early analysis suggests that AHRT has decreased urinary symptoms as measured by IPSS. While we await clinical efficacy data, these data suggest little difference in toxicity with AHRT, partially alleviating concerns related to the toxicity of this regimen.
DXA scans at yearly timepoints (+/-6mos) were reviewed: nZ35 at 1 yr, nZ25 at 2 yrs, and nZ11 at 3 yrs. Mean BMD declines (g/cm 2) at FN, TH, and SP were:-0.026 (2.9%),-0.015 (1.4%), and-0.029 (2.3%) at 1 yr;-0.026 (2.7%),-0.045 (4.2%), and-0.027 (2%) at 2 yrs; and-0.042 (4.1%),-0.047 (4.4%), and-0.096 (7.6%) at 3 yrs. Comparisons of absolute and % BMD changes showed no significant difference in bone loss in FN vs SP or TH vs SP (all p values>0.05). In subsets with decrease in BMD at any site of 0.03 g/cm 2 , there remained no pattern of greater bone loss in FN vs SP (nZ45) or TH vs SP (nZ48). 21 declines in T-score criteria were observed, more often in spine than hip (9 SP, 6 FN, 6 TH). Of the 9 SP, 5 declined in SP only; and 3 FN and 2 TH declined without change in SP. Conclusion: Pelvic RT + LT-ADT for advanced PrCa was not associated with greater BMD decrease in the FN/TH (RT exposed) versus lumbar SP (not RT exposed). These preliminary results challenge the notion that the primary influence of bone loss and potential skeletal events in patients treated with RT + LT-ADT is due to the contributions of RT when LT-ADT is used; and should be verified prospectively.
the extent of prostate intrafraction translation and rotation has been previously investigated, the clinical impact of rotation independent of translation has not. Several series have characterized low rates of rectal toxicity when SBRT is used with different dose regimens. This study attempts to quantify the impact of intrafraction rotation on grade 2+ rectal toxicity for men diagnosed with prostate cancer treated with SBRT. Materials/Methods: Between April 11, 2006 and August 13, 2018, 1712 patients with prostate cancer were treated with robotic-based SBRT at an academic institution. 91.2% were treated with 3500cGy in 5 fractions while 8.8% received 3625cGy. 328 (19.7%) patients received ADT as a component of their treatment. By NCCN grouping, patients were treated for low risk (26.9%), intermediate risk (60.1%), and high risk (13.0%) disease. Each fraction employed real-time intrafraction translation correction. Due to prostate fiducial configuration or body habitus, 75 (4.4%) patients did not receive intrafraction rotation correction during treatment. Intrarectal amifostine was administered to patients prior to each SBRT fraction. Long-term rectal toxicity was scored by RTOG late toxicity scale. Freedom from grade 2+ proctitis was assessed using the Kaplan-Meier method and analyzed using Cox regression methods. Results: 13 patients developed grade 2 proctitis while 7 developed the grade 3 endpoint. 0.41% of all patients required hyperbaric oxygen or procedural intervention to manage toxicity. With a mean follow-up of 29 months (6-148), the 5-year freedom from grade 2+ proctitis was 97.8%. Rectal bleeding was more likely for patients older than age 75 (7.4% vs. 2.0%, pZ.003). In rare cases where intrafraction rotation was not corrected, a higher rate of patients experienced rectal bleeding (10.5% vs. 2.9%, pZ.03). Dosimetrically, a rectal V3600cGy <3cc predicted for decreased risk of bleeding (2.6% vs. 7.8%, pZ.006), as did Rectal V3400cGy<6cc's (1.9% vs. 4.3%, pZ.021). NCCN risk grouping, ADT, Race, and prescription dose (3500cGy vs. 3625cGy) were not significant. On multivariate analysis, the lone predictor of grade 2+ proctitis was intrafraction rotation non-correction (OR 4.033, CI 1.042-15.610, pZ.043). Conclusion: SBRT for prostate cancer is well tolerated with a low actuarial risk of grade 2+ proctitis. Prostate rotation independent of translation has the potential to modestly affect rectal toxicity. In patients treated on robotic platforms with pre-treatment administration of amifostine, intrafraction translation and rotation correction minimizes long-term rates of rectal bleeding.
biochemical control rates with regimens involving SBRT with intraprostatic dose escalation. While pelvic radiation and ADT did not predict for improved outcome, dosing of 38-40 Gy in 4-5 fractions was associated with a modest increase in 5-year bRFS.
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