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Purpose/Objective(s): The current study reports long-term overall survival (OS) and biochemical freedom from recurrence (BFFR) after stereotactic body radiation therapy (SBRT) for men with intermediate and high-risk prostate cancer in a single community hospital setting with early adoption. Materials/Methods: Ninety-seven consecutive men with intermediate and high-risk prostate cancer treated with SBRT between 2007 and 2015 were retrospectively studied. Categorical variables for analysis included National Comprehensive Cancer Network risk group, race, Gleason grade group, T stage, use of androgen deprivation therapy, and planning target volume dose. Continuous variables for analysis included pretreatment prostate-specific antigen (PSA), percent cores positive, age at diagnosis, PSA nadir, prostate volume, percent prostate that received 40 Gy, and minimum dose to 0.03 cc of prostate (Dmin). BFFR was assessed using the Phoenix nadir +2 definition. OS and BFFR were estimated using Kaplan–Meier (KM) methodology with comparisons accomplished using log-rank statistics. Multivariable analysis (MVA) was accomplished with a backwards selection Cox proportional-hazards model with statistical significance taken at the p < 0.05 level. Results: Median FU is 78.4 months. Five- and ten-year OS KM estimates are 90.9 and 73.2%, respectively, with 19 deaths recorded. MVA reveals pretreatment PSA (p = 0.032), percent prostate 40 Gy (p = 0.003), and race (p = 0.031) were predictive of OS. Five- and nine-year BFFR KM estimates are 92.1 and 87.5%, respectively, with 10 biochemical failures recorded. MVA revealed PSA nadir (p < 0.001) was the only factor predictive of BFFR. Specifically, for every one-unit increase in PSA nadir, there was a 4.2-fold increased odds of biochemical failure (HR = 4.248). No significant differences in BFFR were found between favorable intermediate, unfavorable intermediate, and high-risk prostate cancer (p = 0.054) with 7-year KM estimates of 96.6, 81.0, and 85.7%, respectively. Conclusions: Favorable OS and BFFR can be expected after SBRT for intermediate and high-risk prostate cancer with non-significant differences seen for BFFR between favorable intermediate, unfavorable intermediate, and high-risk groups. Our 5-year BFFR compares favorably with the HYPO-RT-PC trial of 84%. PSA nadir was predictive of biochemical failure. This study is ultimately limited by the small absolute number of high-risk patients included. [ABSTRACT FROM AUTHOR]

Background: In this phase I/II trial, 5-year physician-assessed toxicity and patient reported quality of life data is reported for patients undergoing moderately hypofractionated intensity modulated radiation therapy (IMRT) for prostate cancer using a simultaneous integrated boost (SIB) and pelvic lymph node (LN) coverage. Materials and Methods: Patients with T1-T2 localized prostate cancer were prospectively enrolled, receiving risk group based coverage of prostate ± seminal vesicles (SVs) ± pelvic lymph nodes (LNs). Low risk (LR) received 69.6 Gy/29 fractions to the prostate, while intermediate risk (IR) and high risk (HR) patients received 72 Gy/30fx to the prostate and 54Gy/30fx to the SVs. If predicted risk of LN involvement >15%, 50.4 Gy/30fx was delivered to pelvic LNs. Androgen deprivation therapy was given to IR and HR patients. Results: There were 55 patients enrolled and 49 patients evaluable at a median follow up of 60 months. Included were 11 (20%) LR, 23 (41.8%) IR, and 21 (38.2%) HR patients. Pelvic LN treatment was given in 25 patients (51%). Prevalence rates of late grade 2 GI toxicity at 1, 3, and 5 years was 5.8, 3.9, and 5.8%, respectively, with no permanent grade 3 events. Prevalence rates of late grade 2 GU toxicity at 1, 3, and 5 years rates were 15.4, 7.7, and 13.5%, respectively, with three grade 3 events (5.8%). The biochemical relapse free survival at 5 years was 88.3%. There were no local, regional, or distant failures, with all patients still alive at last follow up. Conclusion: Moderate hypofractionation of localized prostate cancer utilizing a SIB technique and LN coverage produces tolerable acute/late toxicity. Given equivalent efficacy between moderate hypofractionation schedules, the optimal regimen will be determined by long-term toxicity reported from both the physician and patient perspective. Clinical Trial Registration: www.ClinicalTrials.gov, identifier NCT01117935, Date of Registration: 5/6/2010. [ABSTRACT FROM AUTHOR]

Purpose: No direct comparisons between extreme hypofractionation and conventional fractionation have been reported in randomized trials for the treatment of localized prostate cancer. The goal of this study is to use a propensity score matched (PSM) analysis with the National Cancer Database (NCDB) for the comparison of stereotactic body radiation therapy (SBRT) and intensity modulated radiation therapy (IMRT) for organ confined prostate cancer. Methods: Men with localized prostate cancer treated with radiation dose ≥72 Gy for IMRT and ≥35 Gy for SBRT to the prostate only were abstracted from the NCDB. Men treated with previous surgery, brachytherapy, or proton therapy were excluded. Matching was performed to eliminate confounding variables via PSM. Simple 1-1 nearest neighbor matching resulted in a matched sample of 5,430 (2,715 in each group). Subset analyses of men with prostate-specific antigen (PSA) > 10, GS = 7, and GS > 7 yielded matched samples of 1,020, 2,194, and 247, respectively. Results: No difference in survival was noted between IMRT and SBRT at 8 years (p = 0.65). Subset analyses of higher risk men with PSA > 10 or GS = 7 histology or GS > 7 histology revealed no difference in survival between IMRT and SBRT (p = 0.58, p = 0.68, and p = 0.62, respectively). Variables significant for survival for the matched group included: age (p < 0.0001), primary payor (p = 0.0001), Charlson/Deyo Score (p = 0.0002), PSA (p = 0.0013), Gleason score (p < 0.0001), and use of hormone therapy (p = 0.02). Conclusion: Utilizing the NCDB, there is no difference in survival at 8 years comparing IMRT to SBRT in the treatment of localized prostate cancer. Subset analysis confirmed no difference in survival even for intermediate- and high-risk patients based on Gleason Score and PSA. [ABSTRACT FROM AUTHOR]

Objectives: The primary objective of this study is to compare freedom from biochemical failure (FFBF) between stereotactic body radiation therapy (SBRT) and intensity-modulated radiation therapy (IMRT) for patients with organ confined prostate cancer treated between 2007 through 2012 utilizing the 2015 National Comprehensive Cancer Network (NCCN) risk stratification guidelines. A secondary objective is to compare our updated toxicity at last follow-up compared with pretreatment with respect to bowel, bladder, sexual functioning, and need for invasive procedures between the two groups. Methods: We retrospectively reviewed 270 consecutive men treated with either SBRT (n = 150) or IMRT (n = 120) at a community hospital with two distinct radiation departments and referral patterns. Charts were reviewed for pretreatment and treatment factors including race, age, clinical T stage, initial PSA, Gleason score, use of androgen deprivation therapy, treatment with SBRT vs. IMRT, as well as stratification by 2015 NCCN guidelines. Kaplan–Meier (KM) methodology was used to estimate FFBF, with statistical comparisons accomplished using log rank tests. Multivariable Cox proportional hazard modeling was used to establish independent factors prognostic of biochemical failure. Descriptive statistics were used to describe toxicity graded by a modified Radiation Therapy Oncology Group (RTOG) late radiation morbidity scoring system. Results: Significant prognostic factors in univariate analysis for FFBF included NCCN risk groups (p = 0.0032), grade (p = 0.019), and PSA (p = 0.008). There was no significant difference in FFBF between SBRT vs. IMRT (p = 0.46) with 6-year actuarial FFBF of 91.9% for SBRT and 88.9% for IMRT. Multivariable analysis revealed only the NCCN risk stratification to be significant predictor for FFBF (p = 0.04). Four-year actuarial FFBF by NCCN risk stratification was 100% very low risk, 100% low risk, 96.5% intermediate risk, 94.5% high risk, and 72.7% very high risk. There were no grade 3 gastrointestinal or genitourinary toxicities for either SBRT or IMRT at last follow-up. Conclusion: No significant difference in FFBF was found between SBRT and IMRT for organ confined prostate cancer in multivariable analysis within this retrospective data set. Overall toxicity was low. The 2015 NCCN risk stratification was validated in this population and was the only significant factor for FFBF in multivariable analysis. [ABSTRACT FROM AUTHOR]