Prognostic utility of biopsy-based PTEN and ERG status on biochemical progression and overall survival after SBRT for localized prostate cancer.

Introduction/background: Phosphatase and tensin homolog (PTEN) genomic deletions and transmembrane protease, serine 2/v-ets avian erthyroblastosis virus E26 oncogene homolog (ERG) rearrangements are two of the most common genetic abnormalities associated with prostate cancer. Prior studies have demonstrated these alterations portend worse clinical outcomes. Our objective is to evaluate the impact of biopsy-determined PTEN losses and TMPRSS2-ERG fusion on biochemical progression-free survival (bPFS) and overall survival (OS) in patients who receive SBRT for localized prostate cancer. Methods/materials: Patients received SBRT for localized prostate cancer on a prospective quality-of-life (QoL) and cancer outcomes study. For each patient, the single biopsy core with the highest grade/volume of cancer was evaluated for PTEN and ERG abnormalities. Differences in baseline patient and disease characteristics between groups were analyzed using ANOVA for age and χ2 for categorical groupings. bPFS and OS were calculated using the Kaplan Meier (KM) method with Log-Rank test comparison between groups. Predictors of bPFS and OS were identified using the Cox proportional hazards method. For all analyses, p <0.05 was considered statistically significant. Results: Ninety-nine consecutive patients were included in the analysis with a median follow-up of 72 months. A statistically significant improvement in bPFS (p = 0.018) was observed for wild type ERG patients with an estimated 5-year bPFS of 94.1% vs. 72.4%. Regarding PTEN mutational status, significant improvements in were observed in both bPFS (p = 0.006) and OS (p < 0.001), with estimated 5-year bPFS rates of 91.0% vs. 67.9% and 5-year OS rates of 96.4% vs. 79.4%. When including both ERG and PTEN mutational status in the analysis, there were statistically significant differences in both bPFS (p = 0.011) and OS (p < 0.001). The estimated 5-year bPFS rates were 100%, 76.6%, 72.9%, and 63.8% for patients with ERG+/PTEN+, ERG-/PTEN+, ERG+/PTEN-, and ERG-/PTEN- phenotypes respectively. The estimated 5-year OS rates were 93.9%, 100%, 80.0%, and 78.7% for patients with ERG+/PTEN+, ERG-/PTEN+, ERG+/PTEN-, and ERG-/PTEN- phenotypes respectively. Conclusion: ERG rearrangements and PTEN deletions detected on biopsy samples are associated with poorer oncologic outcomes in prostate cancer patients treated with SBRT and merit further study in a dedicated prospective trial.

Intensity modulated radiation therapy with stereotactic body radiation therapy boost for unfavorable prostate cancer: five-year outcomes.

Purpose: Intensity-modulated radiation therapy (IMRT) with brachytherapy boost for unfavorable prostate cancer has been shown to improve biochemical relapse-free survival compared to IMRT alone. Stereotactic body radiation therapy (SBRT) is a less-invasive alternative to brachytherapy. Early outcomes utilizing SBRT boost suggest low rates of high-grade toxicity with a maintained patient-reported quality of life. Here, we report the 5-year progression-free survival (PFS) and prostate cancer-specific survival (PCSS) of patients treated with IMRT plus SBRT boost. Materials and methods: Between 2008 and 2020, 255 patients with unfavorable prostate cancer were treated with robotic SBRT (19.5 Gy in three fractions) followed by fiducial-guided IMRT (45-50.4 Gy) according to an institutional protocol. For the first year, the patient's PSA level was monitored every 3 months, biannually for 2 years, and annually thereafter. Failure was defined as nadir + 2 ng/mL or a rising PSA with imaging suggestive of recurrence. Detection of recurrence also included digital rectal examination and imaging studies, such as MRI, CT, PET/CT, and/or bone scans. PFS and PCSS were calculated using the Kaplan-Meier method. Results: The median follow-up period was 71 months. According to the NCCN risk classification, 5% (13/255) of the patients had favorable intermediate-risk disease, 23% (57/255) had unfavorable intermediate-risk disease, 40% (102/255) had high-risk disease, and 32% (83/255) had very high-risk disease. Androgen deprivation therapy was administered to 80% (204/255) of the patients. Elective pelvic lymph node IMRT was performed in 28 (10%) patients. The PFS for all patients at 5 years was 81% (favorable intermediate risk, 91%; unfavorable intermediate risk, 89%; high-risk, 78%; and very-high risk, 72%). The PCSS for all patients at 5 years was 97% (favorable intermediate risk, 100%; unfavorable intermediate risk, 100%; high risk, 100%; and very high risk, 89%). Conclusion: The incidence of failure following IMRT plus SBRT for unfavorable prostate cancer remains low at 5 years.

Radiotherapy Induces Innate Immune Responses in Patients Treated for Prostate Cancers.

PURPOSE: Radiotherapy is a curative therapeutic modality used to treat cancers as a single agent or in combination with surgery and chemotherapy. Advanced radiotherapy technologies enable treatment with large fractions and highly conformal radiation doses to effect free-radical damage to cellular DNA leading to cell-cycle arrest, cell death, and innate immune response (IIR) stimulation. EXPERIMENTAL DESIGN: To understand systemic clinical responses after radiation exposure, proteomic and metabolomic analyses were performed on plasma obtained from patients with cancer at intervals after prostate stereotactic body radiotherapy. Pathway and multivariate analyses were used to delineate molecular alterations following radiotherapy and its correlation with clinical outcomes. RESULTS: DNA damage response increased within the first hour after treatment and returned to baseline by 1 month. IIR signaling also increased within 1 hour of treatment but persisted for up to 3 months thereafter. Furthermore, robust IIR and metabolite elevations, consistent with an early proinflammatory M1-mediated innate immune activation, were observed in patients in remission, whereas patients experiencing prostate serum antigen-determined disease progression demonstrated less robust immune responses and M2-mediated metabolite elevations. CONCLUSIONS: To our knowledge, these data are the first report of longitudinal proteomic and metabolomic molecular responses in patients after radiotherapy for cancers. The data supports innate immune activation as a critical clinical response of patients receiving radiotherapy for prostate cancer. Furthermore, we propose that the observed IIR may be generalized to the treatment of other cancer types, potentially informing multidisciplinary therapeutic strategies for cancer treatment.

Prostate Cancer Treatment with Pencil Beam Proton Therapy Using Rectal Spacers sans Endorectal Balloons.

Purpose: Proton beam radiotherapy (PBT) has been used for the definitive treatment of localized prostate cancer with low rates of high-grade toxicity and excellent patient-reported quality-of-life metrics. Technological advances such as pencil beam scanning (PBS), Monte Carlo dose calculations, and polyethylene glycol gel rectal spacers have optimized prostate proton therapy. Here, we report the early clinical outcomes of patients treated for localized prostate cancer using modern PBS-PBT with hydrogel rectal spacing and fiducial tracking without the use of endorectal balloons. Materials and Methods: This is a single institutional review of consecutive patients treated with histologically confirmed localized prostate cancer. Prior to treatment, all patients underwent placement of fiducials into the prostate and insertion of a hydrogel rectal spacer. Patients were typically given a prescription dose of 7920 cGy at 180 cGy per fraction using a Monte Carlo dose calculation algorithm. Acute and late toxicity were evaluated using the Common Terminology Criteria for Adverse Events (CTCAE), version 5. Biochemical failure was defined using the Phoenix definition. Results: From July 2018 to April 2020, 33 patients were treated (median age, 75 years). No severe acute toxicities were observed. The most common acute toxicity was urinary frequency. With a median follow-up of 18 months, there were no high-grade genitourinary late toxicities; however, one grade 3 gastrointestinal toxicity was observed. Late erectile dysfunction was common. One treatment failure was observed at 21 months in a patient treated for high-risk prostate cancer. Conclusion: Early clinical outcomes of patients treated with PBS-PBT using Monte Carlo-based planning, fiducial placement, and rectal spacers sans endorectal balloons demonstrate minimal treatment-related toxicity with good oncologic outcomes. Rectal spacer stabilization without the use of endorectal balloons is feasible for the use of PBS-PBT.

Rationale for Utilization of Hydrogel Rectal Spacers in Dose Escalated SBRT for the Treatment of Unfavorable Risk Prostate Cancer.

In this review we outline the current evidence for the use of hydrogel rectal spacers in the treatment paradigm for prostate cancer with external beam radiation therapy. We review their development, summarize clinical evidence, risk of adverse events, best practices for placement, treatment planning considerations and finally we outline a framework and rationale for the utilization of rectal spacers when treating unfavorable risk prostate cancer with dose escalated Stereotactic Body Radiation Therapy (SBRT).

Patient-Reported Financial Burden Following Stereotactic Body Radiation Therapy for Localized Prostate Cancer.

Introduction and Objectives: In patients with localized prostate cancer, 5-fraction, stereotactic body radiation therapy (SBRT) has been found to offer comparable oncologic outcomes and potential for improved treatment compliance compared to conventional, 40-plus fraction radiation therapy (RT). Recent studies of oncologic patient experiences have highlighted both the impact of therapy-associated financial toxicity (FT) on treatment adherence and health-related quality of life (HRQOL). Methods: A cross-sectional assessment of FT after SBRT was performed using the 12-item COST questionnaire. The total questionnaire score (range 0-44) was used to evaluate the FT grade (0-3), with a higher COST value representing lower grade. The patient zip code was used to approximate the distance from the index hospital. Univariate and multivariate analyses of the average COST score (0-4) are performed. Results: The response rate was 57.5% (332 of 575 consented patients) with 90.7%, 8.2%, and 1.1% experiencing grade 0, 1, and 2 FT, respectively, with no grade 3. Unemployment or disability, non-white race, low income, and concurrent hormonal therapy were associated with a statistically significant worse FT (lower COST value) on univariate and multivariate analyses (p < 0.05). Education level and insurance status significant were evaluated on univariate analysis only. There was a non-statistically significant difference in age, marital status, time since treatment, and distance from the index hospital. Conclusions: SBRT was associated with low FT. However, statistically significant socioeconomic disparities in FT remain despite ultra-hypofractionated treatment.

Ejaculatory Function Following Stereotactic Body Radiation Therapy for Prostate Cancer.

BACKGROUND: Ejaculatory dysfunction is an important male quality of life issue which has not yet been studied in the setting of prostate stereotactic body radiation therapy (SBRT). AIM: The purpose of this study is to evaluate ejaculatory function following SBRT for prostate cancer. METHODS: Two hundred and thirty-one patients on a prospective quality of life study with baseline ejaculatory capacity treated with prostate SBRT from 2013 to 2019 were included in this analysis. Ejaculation was assessed via the Ejaculation Scale (ES-8) from the Male Sexual Health Questionnaire. Patients completed the questionnaire at 1, 3, 6, 9, 12, 18, and 24 months post-SBRT. Elderly patients (Age > 70) and those who received hormonal therapy were excluded from analysis. Patients were treated to 35-36.25 Gy in 5 fractions delivered with the CyberKnife Radiosurgical System (Accuray). OUTCOMES: Ejaculatory function was assessed by ES-8 scores (range 4-40) with lower values representing increased interference or annoyance. RESULTS: Median age at the time of treatment was 65 years. Median follow up was 24 months (IQR 19-24.5 months). 64.5% of patients had ED at baseline (SHIM < 22). The 2-year anejaculation rate was 15%. Mean composite ES-8 scores showed a decline in the first month following treatment then stabilized: 30.4 (start of treatment); 26.5 (1 month); 27.6 (3 month); 27.0 (6 month); 26.2 (9 month); 25.4 (12 month); 25.0 (18 month) and 25.4 (24 month). White race, higher pre-treatment SHIM (≥22), and higher ES-8 (≥31) at treatment start were significantly associated with a decreased probability of a clinically significant decline. Patient-reported ejaculate volume was significantly reduced at all time points post-SBRT. Ejaculatory discomfort peaked at 1 month and 9 months post-SBRT. Prior to treatment, 8.0% of men reported that they were very to extremely bothered by their ejaculatory dysfunction. The number of patients reporting this concern increased to 14.4% at one year and dropped to 11% at 24-months post-SBRT. CLINICAL TRANSLATION: Patients undergoing prostate SBRT may experience meaningful changes in ejaculatory function and should be counseled on the trajectory of these side effects. STRENGTHS & LIMITATIONS: This was a retrospective analysis of a prospectively maintained database. Subjective questionnaire responses captured limited aspects of ejaculatory function in this cohort. CONCLUSION: The high incidence of moderate to extreme bother in ejaculatory function before and after SBRT suggests a need for novel approaches to improving ejaculation. Sholklapper T, Creswell M, Cantalino J, et al. Ejaculatory Function Following Stereotactic Body Radiation Therapy for Prostate Cancer. J Sex Med 2022;19:771-780.

Association of baseline self-reported fatigue with overall survival after stereotactic body radiation therapy for localized prostate cancer.

Introduction: Stereotactic Body Radiation Therapy (SBRT) has emerged as a definitive therapy for localized prostate cancer (PCa). However, more data is needed to predict patient prognosis to help guide which patients will benefit most from treatment. The FACIT-Fatigue (FACIT-F) is a well validated, widely used survey for assessing fatigue. However, the role of fatigue in predicting PCa survival has yet to be studied. Herein, we investigate the role of FACIT-F as a baseline predictor for overall survival (OS) in patients undergoing SBRT for localized PCa. Methods: A retrospective review was conducted of 1358 patients who received SBRT monotherapy between January 2008 to April 2021 at an academic, tertiary referral center. FACIT-F scores (range 0 to 52) were summed for patients who answered all 13-items on the survey. FACIT-F total scores of ≥35 represented severe fatigue. Patients receiving androgen deprivation therapy were excluded. Differences in fatigue groups were evaluated using chi-squared tests. OS rates were determined using the Kaplan-Meier method and predictors of OS were evaluated using Cox proportional hazard method. Results: Baseline full FACIT-F scores and survival data was available for 891 patients. 5-year OS was 87.6% and 95.2%, respectively, for the severely fatigued and non-fatigued groups. Chi-squared analysis of fatigue groups showed no significant difference in the following categories: D'Amico risk group, age, ethnicity, grade group, T-stage, or PSA density. Severe fatigue was associated with a significant decrease in OS (hazard ratio 2.76; 95%CI 1.55 - 4.89). The Cox proportional hazard model revealed that age and FACIT-F were both statistically significant (p <0.05). Conclusion: Baseline FACIT-F scores are significantly associated with OS. Higher FACIT-F scores, representing less fatigued patients, are associated with an overall survival benefit. These results indicate that the FACIT-F survey could serve as an additional metric for clinicians in determining prognostic factors for patients undergoing SBRT.

Novel Paired Normal Prostate and Prostate Cancer Model Cell Systems Derived from African American Patients.

Prostate cancer is the most frequently diagnosed solid malignancy in men. African American (AA) men are at greater risk for developing prostate cancer, and experience higher mortality rates, as compared with Caucasian American men. However, mechanistic studies to understand this health disparity have been limited by the lack of relevant in vitro and in vivo models. There is an urgent need for preclinical cellular models to investigate molecular mechanisms underlying prostate cancer in AA men. We collected clinical specimens from radical prostatectomies of AA patients and established 10 paired tumor-derived and normal epithelial cell cultures from the same donors, which were further cultivated to extend the growth under "conditional reprogramming." Clinical and cellular annotations characterized these model cells as intermediate risk and predominantly diploid. Immunocytochemical analyses demonstrated variable expression levels of luminal (CK8) and basal (CK5, p63) markers in both normal and tumor cells. However, expression levels of TOPK, c-MYC, and N-MYC were markedly increased only in tumor cells. To determine cell utility for drug testing, we examined viability of cells following exposure to the antiandrogen (bicalutamide) and two PARP inhibitors (olaparib and niraparib) and observed decreased viability of tumor-derived cells as compared with viability of normal prostate-derived cells. Significance: Cells derived from prostatectomies of AA patients conferred a bimodal cellular phenotype, recapitulating clinical prostate cellular complexity in this model cell system. Comparisons of viability responses of tumor derived to normal epithelial cells offer the potential for screening therapeutic drugs. Therefore, these paired prostate epithelial cell cultures provide an in vitro model system suitable for studies of molecular mechanisms in health disparities.

Bothersome Hematospermia Following Stereotactic Body Radiation Therapy for Prostate Cancer.

BACKGROUND: Hematospermia following prostate radiation therapy is a benign and often self-limiting side effect. However, it may be bothersome to some men and their partners with a negative impact on sexual quality of life (QOL). This study sought to evaluate the incidence, duration, and resolution of hematospermia in patients following stereotactic body radiation therapy (SBRT) for prostate cancer. METHODS: 227 patients treated with SBRT from 2013 to 2019 at Georgetown University Hospital for localized prostate carcinoma with a minimum follow up of two years were included in this retrospective review of data that was prospectively collected. Patients who were greater than 70 years old and/or received hormonal therapy were excluded. Hematospermia was defined as bright red blood in the ejaculate. Time points for data collection included initial consultation, pre-treatment, 1-, 3-, 6-, 9-, 12-, 18-, 24-month. All patients were treated with the CyberKnife Radiosurgical System (Accuray). Data on hematospermia including duration, resolution and recurrence was collected. Utilization of 5-alpha reductase inhibitors was documented at each visit. RESULTS: 227 patients (45 low-, 177 intermediate-, and 5 high-risk according to the D'Amico classification) at a median age of 65 years (range 47-70) received SBRT for their localized prostate cancer. The 2-year cumulative incidence of hematospermia was 5.6%(14 patients). For these patients, all but one patient (93%) saw resolution of their hematospermia by two years post-SBRT. The median time for hematospermia was 9 months post-treatment. Of the 14 patients who reported hematospermia, 70% were managed with 5-alpha reductase inhibitors. Hematospermia was transient in most patients with 70% of the men reporting resolution by the next follow-up visit. CONCLUSION: The incidence of bothersome hematospermia following SBRT was low. Hematospermia, as noted by other studies, often self-resolves. 5-alpha reductase inhibitors may lead to quicker resolution of bothersome hematospermia.

Implementation of instructional videos improves nursing comfort with commonly encountered urinary catheter care scenarios.

INTRODUCTION: Placement of coudé catheters, manual irrigation of urinary catheters, and management of continuous bladder irrigation (CBI) are routine interventions for which nurses often receive little or no formal education. In this study, our aim was to determine factors associated with higher comfort levels for these catheter-care techniques and to assess whether online instructional videos could be used to improve nursing comfort. MATERIALS AND METHODS: Three 5-minute videos were created to demonstrate proper technique for coudé catheter placement, manual irrigation of a catheter, and management of CBI. An online module with pre- and post-video surveys was created and administered to all nursing staff at MedStar Georgetown University Hospital. RESULTS: A total of 821 nurses participated in this study and completed the online module with both pre-- and post-video surveys. Using a 10-point Likert scale, pre-video median comfort levels for coudé catheter placement, manual irrigation of a catheter, and management of CBI were 5, 6, and 5, respectively. Post-video median comfort levels increased significantly to 9, 8, and 8, respectively (p < 0.001). In the linear regression models, prior formal training was significantly associated with higher baseline comfort levels for all three techniques (p < 0.001). CONCLUSIONS: Prior formal training as well as baseline nursing comfort levels for common catheter related techniques tend to be low and the implementation of simple instructional videos via an online platform may be a useful strategy for improving nursing comfort. This study demonstrates a reproducible strategy for disseminating catheter education for nurses on a larger scale.

Retzius-sparing Robot-assisted Radical Prostatectomy Leads to Durable Improvement in Urinary Function and Quality of Life Versus Standard Robot-assisted Radical Prostatectomy Without Compromise on Oncologic Efficacy: Single-surgeon Series and Step-by-step Guide.

BACKGROUND: Retzius-sparing robot-assisted radical prostatectomy (RS-RARP) has been shown to improve continence. However, questions remain regarding feasibility and generalizability of technique and outcomes. OBJECTIVE: To compare the outcomes of 140 consecutive standard robot-assisted radical prostatectomy (S-RARP) versus RS-RARP. DESIGN, SETTING, AND PARTICIPANTS: A total of 70 S-RARPs were performed followed by 70 RS-RARPs. Demographic, pathologic, and functional outcomes were compared preoperatively and through 12 mo. Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP) was used to compare functional outcomes. Logistic and linear regression analyses were utilized to analyze variables associated with EPIC-CP urinary incontinence and overall quality of life (QOL) scores, and oncologic outcomes. Cox regression analysis was used to analyze incontinence at 12 mo. SURGICAL PROCEDURE: RS-RARP versus S-RARP. MEASUREMENTS: Patient and tumor characteristics (age, body mass index, prostate-specific antigen, Charlson Comorbidity Index, Gleason group, clinical stage, and Prostate Imaging Reporting and Data System score), perioperative outcomes (console time, estimated blood loss, postoperative complications, and length of stay), oncologic outcomes (positive surgical margin [PSM], and biochemical recurrence), overall and 12-mo continence rates (zero pads and zero to one safety pad), time to continence, potency (erection sufficient for sexual activity), EPIC-CP urinary incontinence, sexual function, and overall QOL scores. RESULTS AND LIMITATIONS: Median follow-up for S-RARP versus RS-RARP was 46.3 versus 12.3 mo. RS-RARP versus S-RARP had improved overall continence rates at total follow-up (95.7% vs 85.7%, p = 0.042) and 12-mo follow-up (97.6% vs 81.4%, p = 0.002), and faster return to continence (zero to one safety pad, 44 vs 131 d, p < 0.001). RS-RARP EPIC-CP urinary incontinence and overall QOL scores remained significantly better at 12 mo. There were no differences in overall PSM rates, although RS-RARP had lower rates of nonfocal PSMs. There were no differences in sexual function. In multivariate analysis, RS-RARP was significantly associated with improved 12-mo EPIC-CP urinary incontinence and improved QOL scores, but was not associated with PSM or biochemical recurrence. Limitations include retrospective study design and unequal follow-up; however, significantly better RS-RARP continence at 12 mo is striking despite fewer patients attaining 12-mo follow-up. CONCLUSIONS: RS-RARP significantly improves early and long-term continence without compromising oncologic outcomes and leads to overall improved QOL. PATIENT SUMMARY: Retzius-sparing robot-assisted radical prostatectomy is an emerging technique for robotic radical prostatectomy that improves urinary function and quality of life without compromising cancer control.

Management of Isolated Local Failures Following Stereotactic Body Radiation Therapy for Low to Intermediate Risk Prostate Cancer.

Background: Stereotactic body radiation therapy (SBRT) is a safe and effective treatment option for patients with low to intermediate risk prostate cancer (1). SBRT results in very low PSA nadirs secondary to the delivery of high biologically effective doses. Studies reporting on the diagnosis, confirmation, and management of salvageable isolated local failures (ILF) are limited. This study aims to determine the incidence and management approach of ILF after SBRT in a large single institution cohort. Method: All patients with low or intermediate risk localized prostate cancer treated with SBRT at Georgetown University Hospital were eligible for this study. Treatment was delivered using robotic SBRT with doses of 35-36.25 Gy in five fractions. ILF were diagnosed using multiparametric MRI and/or biopsy prompted by rising PSA levels after achieving long-term nadir. Patient's characteristics were extracted from a prospective institutional quality of life trial (IRB 2009-510). Type of salvage therapy and post-salvage PSA were determined on subsequent follow-up and chart review. Results: Between December 2008 to August 2018, 998 men with low to intermediate risk prostate cancer were eligible for inclusion in this analysis. Twenty-four patients (low risk, n = 5; intermediate risk, n = 19) were found to have ILF within the prostate on either MRI (n = 19) and/or biopsy (n = 20). Median pre-treatment PSA was 7.55 ng/ml. Median time to diagnosis of ILF was 72 months (24-110 months) with median PSA at the time of ILF of 2.8 ng/ml (0.7-33 ng/ml). Median PSA doubling time was 17 months (5-47 months). Thirteen patients with biopsy proven ILF proceeded with salvage therapy (cryotherapy n = 12, HIFU n = 1). Of 12 patients who underwent cryotherapy, 7 had a post-treatment PSA of <0.1 ng/ml. One patient experienced a urethral-cutaneous fistula (grade 3 toxicity). Conclusion: The incidence of isolated local recurrence is rare in our cohort. Diagnosis and management of isolated local failures post-SBRT continues to evolve. Our report highlights the importance of early utilization of MRI and confirmatory biopsy at relatively low PSA levels and long PSA doubling time (1). Additionally, undetectable PSA levels after salvage therapy supports the role of early treatment in ILF (1). Further research is needed to determine appropriate patient selection and salvage modality in this population.

Urinary Morbidity in Men Treated With Stereotactic Body Radiation Therapy (SBRT) for Localized Prostate Cancer Following Transurethral Resection of the Prostate (TURP).

Background: Clinical data suggest that stereotactic body radiation therapy (SBRT) provides similar clinical outcomes as other radiation modalities for prostate cancer. However, data reporting on the safety of SBRT after TURP is limited. Herein, we report our experience using SBRT to deliver hypofractionated radiotherapy in patients with a history of TURP including physician-reported toxicities and patient-reported quality of life. Methods: Forty-seven patients treated with SBRT from 2007 to 2016 at Georgetown University Hospital for localized prostate carcinoma with a history of prior TURP were included in this retrospective analysis. Treatment was delivered using the CyberKnife® (Accuray Incorporated, Sunnyvale, CA) with doses of 35 Gy or 36.25 Gy in 5 fractions without prostatic urethral sparing. Toxicities were recorded and scored using the CTCAE v.4. Cystoscopy findings were retrospectively reviewed. Urinary quality of life data was assessed using the International Prostate Symptom Scoring (IPSS) and Expanded Prostate Cancer Index Composite 26 (EPIC-26). A Wilcoxon signed-rank sum test was used to determine if there was a statistically significant increase or decrease in IPSS or EPIC scores between timepoints. Minimally important differences were calculated by obtaining half the standard deviation at time of start of treatment. Results: Forty-seven patients at a median age of 72 years (range 63-84) received SBRT. The mean follow-up was 4.7 years (range 2-10 years). Late Grade 2 and grade 3 urinary toxicity occurred in 23 (48.9%) and 3 (6.4%) men, respectively. There were no Grade 4 or 5 toxicities. Approximately 51% of patients experienced hematuria following treatment. Mean time to hematuria was 10.5 months. Twenty-five cystoscopies were performed during follow-up and the most common finding was hyperemia, varices of the bladder neck/TURP defect, and/or necrotic tissue in the TURP defect. Baseline urinary QOL composite scores were low, but they did not clinically significantly decline in the first 2 years following treatment. Conclusions: In patients with prior TURP, prostate SBRT was well-tolerated. GU toxicity rates were comparable to similar patients treated with conventionally fractionated radiation therapy. Urinary quality of life was poor at baseline, but did not worsen clinically over time. Stricter dosimetric criteria could potentially improve the rate of high-grade late toxicity, but may increase the risk of peri-urethral recurrence.

Utilization of Iodinated SpaceOAR Vue™ During Robotic Prostate Stereotactic Body Radiation Therapy (SBRT) to Identify the Rectal-Prostate Interface and Spare the Rectum: A Case Report.

We describe the utilization of SpaceOAR Vue™, a new iodinated rectal spacer, during Robotic Stereotactic Body Radiation Therapy (SBRT) for a Prostate Cancer Patient with a contraindication to Magnetic Resonance Imaging. A 69-year-old Caucasian male presented with unfavorable intermediate risk prostate cancer and elected to undergo SBRT. His medical history was significant for atrial fibrillation on Rivaroxaban with a pacemaker. He was felt to be at increased risk of radiation proctitis following SBRT due to the inability to accurately contour the anterior rectal wall at the prostate apex without a treatment planning MRI and an increased risk of late rectal bleeding due to prescribed anticoagulants. In this case report, we discuss the technical aspects of appropriate placement and treatment planning for utilizing SpaceOAR Vue™ with Robotic SBRT.

Rationale for Involved Field Stereotactic Body Radiation Therapy-Enhanced Intermittent Androgen Deprivation Therapy in Hormone-Sensitive Nodal Oligo-Recurrent Prostate Cancer Following Prostate Stereotactic Body Radiation Therapy.

Lymph node recurrent prostate cancer is a common clinical scenario that is likely to increase significantly with the widespread adoption of novel positron emission tomography (PET) agents. Despite increasing evidence that localized therapy is disease modifying, most men with lymph node recurrent prostate cancer receive only systemic therapy with androgen deprivation therapy (ADT). For men who receive localized therapy the intent is often to delay receipt of systemic therapy. Little evidence exists on the optimal combination of local and systemic therapy in this patient population. In this hypothesis generating review, we will outline the rationale and propose a framework for combining involved field SBRT with risk adapted intermittent ADT for hormone sensitive nodal recurrent prostate cancer. In patients with a limited number of nodal metastases, involved field stereotactic body radiation therapy (SBRT) may have a role in eliminating castrate-resistant clones and possibly prolonging the response to intermittent ADT. We hypothesize that in a small percentage of patients, such a treatment approach may lead to long term remission or cure.

Repeat Robotic Partial Nephrectomy: Characteristics, Complications, and Renal Functional Outcomes.

INTRODUCTION: Multifocal and hereditary kidney cancers often require repeated ipsilateral nephron sparing procedures with higher blood loss and complication rates compared to first time renal surgery. Consequently, many surgeons avoid minimally invasive techniques in the setting. We present the characteristics, complications, and short-term renal functional outcomes of patients who underwent a repeat robotic partial nephrectomy (rRPNx). MATERIALS AND METHODS: A database was retrospectively reviewed to identify patients who underwent robotic partial nephrectomies between January 2007 and December 2013. Selection criteria for the rRPNx cohort included patients who had undergone at least two ipsilateral renal surgeries, with the second procedure being an rRPNx. All other patients comprised the initial robotic partial nephrectomy (iRPNx) group. RESULTS: One hundred twenty-four patients who underwent robotic partial nephrectomy during the study period were identified. rRPNx constituted 26 (21%) of the total cases. Age of the rRPNx cohort was similar (p = 0.56), but number of tumors resected was two-fold greater in the rRPNx group (p = 0.44). Neither surgery time nor renal clamp time was significantly longer in either group (p = 0.18 and p = 0.65, respectively). Importantly, estimated blood loss (EBL) was significantly larger than in the iRPNx group (p = 0.01). Both groups had similar intravenous pain medication administration durations (p = 0.32), but postsurgical length of stay was greater for the rRPNx patients (p = 0.011). There were no significant differences in clavian complication rates (p = 0.17-0.39), with the exception of urine leak which occurred more frequently in the rRPNx group (p = 0.01). There was no difference in percent change in serum creatinine or estimated glomerular filtration rate (p = 0.89 and p = 0.67, respectively). CONCLUSIONS: rRPNx is safe and feasible in select patients. EBL, postoperative lengths of stay, and urine leak were the only factors significantly associated with rRPNx compared to iRPNx. Patient 3-month follow-up revealed excellent and comparable outcomes between the two groups.

Renal functional outcomes after robotic multiplex partial nephrectomy: the National Cancer Institute experience with robotic partial nephrectomy for 3 or more tumors in a single kidney.

OBJECTIVE: To identify renal function outcomes after robotic multiplex partial nephrectomy (RMxPNx), we reviewed our institutional database at the National Institutes of Health, National Cancer Institute. To our knowledge, we present the largest series of RMxPNx renal function outcomes to date. Robotic partial nephrectomy has been employed for oncologic control and to prevent dialysis dependence in hereditary multifocal renal cell carcinoma conditions. We have termed robotic surgery on a single kidney with three or more lesions a RMxPNx. MATERIALS AND METHODS: We evaluated patients from a prospectively maintained database at a single institution (NIH/NCI) that underwent RMxPNx from 2007 to 2013. Demographic and operative data were compiled with statistical analysis with T test performed to determine renal function outcomes. RESULTS: A total of 54 patients underwent RMxPNx. Mean number of tumors removed was 8.63 (range 3-52). Mean preoperative creatinine and eGFR were 1.02 ± 0.26 mg/dL and 85.4 ± 21.5 mL/min, respectively. Postoperatively, creatinine increased from baseline by 0.45 mg/dL (p < 0.001). Similarly, a mean decrease in eGFR by 24.6 mL/min was observed (p < 0.001). At 3-month follow-up, the creatinine increase from baseline was 0.05 mg/dL (p = 0.10) and mean decrease in eGFR was 3.01 mL/min (p = 0.21). When stratifying based on preoperative CKD stages I-III, similar results were observed. CONCLUSION: Robotic multiplex partial nephrectomy is a safe and feasible approach to patients with multifocal renal masses. These complex surgeries have a demonstrated learning curve, but this minimally invasive approach for nephron-sparing surgery allows patients to preserve renal function where they would otherwise require open surgery or a radical nephrectomy.