Framework Development: Standardizing Definition of Advanced Practice Radiation Therapy Activities for Clinical Workload Quantification.

Purpose: Advanced practice (AP) in radiation therapy (RT) is being implemented around the globe. In an effort to advance the understanding of the similarities and differences in APRT roles in Ontario, Canada, a community of practice (CoP) sought ways to provide quantitative data on the nature of APRT clinical activities and the frequency with which these activities were being executed. Methods: In 2017, a consensus building project involving 20 APRTs and 14 radiation therapy (RT) department managers in Ontario was completed to establish a mechanism to quantify APRTs' clinical impact. In Round 1 & 2, expert feedback was gathered to generate an Advanced Practice (AP) Activity List. In Round 3: 20 APRTs completed an online survey to assess the importance and applicability of each AP Activity to their role using Likert scale (0-5). A final AP Activity List & Definitions was generated. Results & discussion: Round 1: Forty-seven AP activities were identified. Round 2: 3/14 RT managers provided 145 feedback statements on Round 1 AP Activity List. The working group used RT managers' feedback to clarify AP activities and definitions, specifically merging 33 unique AP activities to create 11 inclusive AP activities and eliminating 8 activities identified from Round 1. The most inclusive AP activity created was #1 New Patient Consultation, this AP Activity is merged from 7 unique AP activities. Incorporating RT managers' feedback with the internal AP clinical workload lists from 2 Ontario cancer centres resulted in a revised AP Activity List with 20 AP inclusive activities. Round 3: 14/20 APRTs provided Likert scores on this revised list. The most applicable AP activities (mean score) were #16 Technical Consultation (4.0), #15 Contouring Target Volume (3.8) and #2 Planning Consultation (3.8); the least applicable was #18 MR Applicator Assessment (0.9). Conclusions: This is the first systematic attempt to build consensus on AP clinical activities. Non-clinical APRT activities related to research, education, innovation, and program development were not in the scope of this project. The Final AP Activity List & Definitions serves as a framework that allows standardized and continuous monitoring of AP clinical activities and impact.

Opioid consumption and pain in patients with gynecological cancer who underwent spinal anesthesia vs. general anesthesia for interstitial brachytherapy.

AIMS: Interstitial brachytherapy (ISBT) is an effective option for delivering conformal high dose radiation to the target volume with better organ-at risk sparing but is thought to be more invasive and painful than other methods. This study investigated pain levels and opioid consumption in patients who received spinal anesthesia (SA) or general anesthesia (GA) for their ISBT. MATERIALS AND METHODS: Patients that underwent ISBT from April 2014 to September 2018 were analyzed from a prospective institutional database. The most prevalent malignancies were cervical (45%), recurrent endometrial (27%) and vaginal (20%) cancers. Baseline patient characteristics, radiation treatment details, anesthesia records, and inpatient charts were obtained. Opioid consumption was quantified as oral morphine equivalent per day (OMEq/day) from implantation until removal. Pain score levels were collected by using an 11-point scoring system. RESULTS: Ninety nine patients received GA and 40 patients received SA as their anesthesia for ISBT. During their first admission, 76 patients (55%) required intravenous opioids. Patients receiving SA had significantly lower mean pain scores on the morning of their procedure 6 (Interquartile range [IQR] 2-8) vs. 0 (IQR: 0-1); p < 0.001]. Pain did not significantly differ between cohorts at any other time. During the first admission, SA patients had a lower median opioid usage of 23 (IQR: 9-47) mg/day compared to GA patients at 38 (IQR: 21-71) mg/day (p = 0.011). No difference in opioid consumption was seen during subsequent admissions. CONCLUSIONS: In patients undergoing ISBT, SA provides better immediate pain control post insertion compared to GA. Patients who received SA used lower amounts of opioids during their first ISBT insertion.

Translating interprofessional collaboration competencies to an international research team.

INTRODUCTION: While there has been strong emphasis on enhancing interprofessional education and interprofessional care in the published literature, there is relatively little literature focused on advancing interprofessional research. In extrapolating from the current frameworks of interprofessional collaboration (IPC), it becomes clear that the core competencies of IPC are transferable to research teams. The aim of this paper is to present our experience of an international research team framed within core competencies for IPC. METHODS: A simplified narrative inquiry approach was used to share the experience of an international research team framed within six core competencies of IPC. RESULTS AND DISCUSSION: By way of our international research collaboration, we demonstrate the translation of key core competencies for IPC. We share key learnings and mitigation strategies for the successful outcomes of the research team. CONCLUSION: To embark on a successful international research collaboration requires integrating IPC core competencies across the entire research continuum. In addition to the core competencies of collaboration, enablers to success also include digital collaborative forums, existing professional relationships and research projects that offer global meaning and value.

Single-fraction HDR brachytherapy as monotherapy in low and intermediate risk prostate cancer: Outcomes from two clinical trials with and without an MRI-guided boost.

PURPOSE: Single-fraction HDR monotherapy for the treatment of localized prostate cancer is appealing, but published outcomes are discouraging. An approach to improve local control is MRI-guided focal dose-escalation to the dominant intraprostatic lesion (DIL). Here we report a comparison of outcomes from two phase II clinical trials with and without a focal boost. METHODS: Patients had low or intermediate-risk disease. Patients in Trial1 received a single 19 Gy HDR implant to the whole prostate. Trial2 incorporated an additional MRI-guided focal DIL boost to at least 23 Gy. ADT was not allowed. Toxicities (CTCAEv4.0) and quality of life (EPIC) were collected. Biochemical failure (BF) was defined as nadir +2. Univariate and multivariate logistic regression analysis was conducted to search for predictors of BF. RESULTS: Trial1 had 87 patients with a median follow-up of 62 months, while Trial2 had 60 patients with a median follow-up of 50 months. The five-year cumulative BF rate was 32.6% and 31.3%, respectively (p = 0.9). 77.5% of failures were biopsy-confirmed local failures, all of which underwent local salvage therapy. The addition of a DIL boost was not associated with worse toxicity or QOL. Baseline PSA and Gleason score correlated with BF, but none of the dosimetric parameters was a significant predictor of BF. CONCLUSIONS: MRI-guided focal boost was safe and well tolerated, but did not improve local control after 19 Gy single-fraction HDR monotherapy, and the control rates were unacceptable. Single-fraction HDR monotherapy for prostate cancer should not be offered outside of clinical trials.

Evaluating the Tolerability of a Simultaneous Focal Boost to the Gross Tumor in Prostate SABR: A Toxicity and Quality-of-Life Comparison of Two Prospective Trials.

PURPOSE: Dose-escalated stereotactic ablative radiotherapy (SABR) to the whole prostate may be associated with better outcomes but has a risk of increased toxicity. An alternative approach is to focally boost the dominant intraprostatic lesion (DIL) seen on magnetic resonance imaging. We report the toxicity and quality-of-life (QOL) outcomes of 2 phase 2 trials of prostate and pelvic SABR, with or without a simultaneous DIL boost. METHODS AND MATERIALS: The first trial treated patients with high-risk prostate cancer to a dose of 40 Gy to the prostate and 25 Gy to the pelvis in 5 fractions. The second trial treated patients with intermediate-risk and high-risk prostate cancer to a dose of 35 Gy to the prostate, 25 Gy to the pelvis, and a DIL boost up to 50 Gy in 5 fractions. Acute toxicities, late toxicities, and QOL were assessed. RESULTS: Thirty patients were enrolled in each trial. In the focal boost cohort, the median DIL D90% was 48.3 Gy. There was no significant difference in acute grade ≥2 gastrointestinal or genitourinary toxicity between the 2 trials or in cumulative worst late gastrointestinal or genitourinary toxicity up to 24 months. There was no significant difference in QOL domain scores or minimally clinical important change between the 2 trials. CONCLUSIONS: Prostate and pelvic SABR with a simultaneous DIL boost was feasible. Acute grade ≥2 toxicity, late toxicity, and QOL seemed to be comparable to a cohort that did not receive a focal boost. Further follow-up will be required to assess long-term outcomes, and randomized data are required to confirm these findings.

Catalyst for Change: Measuring the Effectiveness of Training of All Health Care Professionals to Provide Brief Intervention for Smoking Cessation to Cancer Patients.

BACKGROUND: Smoking cessation is recommended to prevent individuals from developing cancer, with additional benefits after a cancer diagnosis. Tobacco use during cancer treatments increases the risk of complications and may reduce the effectiveness of treatment; patients who quit smoking are less likely to experience recurrence. Health care professionals play a vital role in assessing and educating cancer patients on how to quit. We report on the effectiveness of peer-to-peer education of a brief smoking cessation intervention to patients. METHODS: An interprofessional team was created to implement and integrate smoking cessation best practices into daily clinical care. Health care providers were provided with peer-to-peer training to provide brief interventions of smoking cessation to patients. After training, participants were invited to complete an electronic survey to assess the effectiveness of the peer-to-peer training sessions. The survey consisted of 3 domains: confidence, comfort, and knowledge. Participants were asked to rate a series of statement questions using a Likert scale as well as to self-assess knowledge. The survey also included open-ended questions to invite respondents to share further comments and feedback. RESULTS: Approximately 90% of staff across the oncology program participated in a training session. This included nurses, radiation therapists, and patient and family support professionals. Sixty-one surveys were returned (30% response rate). Most respondents had >10 years of clinical experience (70%), 91% agreed it was important to support patients in their efforts to quit smoking, 88% agreed they have an impact on their patients' smoking cessation attempts, and 67% had opportunities in daily practice to support smoking cessation. Sixty-one percent would benefit from additional education. Fifty-three percent indicated they experienced challenges providing interventions and patients' responsiveness to the intervention. CONCLUSIONS: Peer-to-peer training for smoking cessation can increase confidence, comfort, and knowledge. Challenges include comfort level of clinician, determining the best time to ask patients, and having the confidence in knowing their scope of practice.

Dosimetric predictors of toxicity and quality of life following prostate stereotactic ablative radiotherapy.

PURPOSE: SABR offers an effective treatment option for clinically localized prostate cancer. Here we report the dosimetric predictors of late toxicity and quality of life (QOL) in a pooled cohort of patients from four phase II trials. METHODS: The combined cohort included all three prostate cancer risk groups. The prescription dose was 35-40 Gy in 5 fractions. Toxicity (CTCAE) and QOL (EPIC) were collected. Multiple dosimetric parameters for the bladder, rectum and penile bulb were collected. Univariate (UVA) followed by multivariate (MVA) logistic regression analysis was conducted to search for significant dosimetric predictors of late GI/GU toxicity, or minimal clinically important change in the relevant QOL domain. RESULTS: 258 patients were included with median follow up of 6.1 years. For QOL, bladder Dmax, V38, D1cc, D2cc, D5cc and rectal V35 were predictors of urinary and bowel MCIC on UVA. On MVA, only bladder V38 remained significant. For late toxicity, various parameters were significant on UVA but only rectal Dmax, V38 and bladder D2cc were significant predictors on MVA. CONCLUSIONS: This report confirms that the high-dose regions in the bladder and rectum are more significant predictors of late toxicity and QOL after prostate SABR compared to low-dose regions. Caution must be taken to avoid high doses and hotspots in those organs.

MRI assisted focal boost integrated with HDR monotherapy study in low and intermediate risk prostate cancer (MARS): Results from a phase II clinical trial.

PURPOSE: There is growing concern that single-fraction HDR monotherapy to a dose of 19 Gy is suboptimal for the treatment of localized prostate cancer. We report the results of a phase II prospective trial of single-fraction 19 Gy HDR monotherapy with MRI-guided simultaneous focal boost. METHODS: Eligible patients had low or intermediate risk prostate cancer and an identified lesion on MRI. TRUS based single-fraction HDR monotherapy with MRI fusion was delivered. The dose prescribed was 19 Gy to the prostate and ≥23 Gy to the dominant intraprostatic lesion (DIL). ADT was not used. The purpose is to report early efficacy results. RESULTS: 60 patients were enrolled, with a median follow-up of 39 months. With MRI T-stage incorporated into the risk-group criteria, 8% had low-risk, 35% had favorable intermediate-risk and 57% had unfavorable intermediate-risk disease. The median dose to 90% of the DIL (D90) was 27.2 Gy, and the median prostate V100% was 96.9%. No acute or late grade ≥3 bowel or urinary toxicity was observed. The cumulative BF probability was 15.2% at 36 months and 31.6% at 48 months. All patients that were fully investigated had local failure only, and 88% of the local failures were at the site of original DIL. The median PSA nadir was 0.79 ng/ml, with a median time to nadir of 32 months. CONCLUSIONS: Focal boost to the MRI-specified gross tumor was well tolerated, but did not adequately improve local control. Single-fraction HDR monotherapy to 19 Gy for prostate cancer provides suboptimal local control, and should not be offered outside of clinical trials.

It Only Takes a Minute: The Development and Implementation of a Patient Experience Survey in Radiation Therapy.

INTRODUCTION: Health care services use surveys to assess patient satisfaction and identify areas for improvement. While it is important to assess patient satisfaction to ensure their needs are met, lengthy questionnaires with closed-ended questions often focus on areas that may be considered important by institutions rather than patients. Recently, focus has shifted toward patient and caregiver experience, which institutions address via appreciative inquiry. The aim of this initiative was the development of a patient experience survey (PES) for radiation therapy patients and caregivers which would allow them to express their opinions and priorities. This patient feedback would then be addressed through quality improvement (QI) projects geared toward improving the overall patient and caregiver experience in radiation therapy. METHODS: A three-question minute survey was developed for use as a PES in the radiation therapy department of an academic oncology program located in a large metropolitan area. Feedback was obtained from patient education and person-centred care experts, as well as 10 radiation therapy patients. All feedback was incorporated to create the final PES; respondents rated their agreement on a five-point Likert scale with the statement "My overall experience in Radiation Therapy was great" and two open-ended questions allowed them to highlight departmental strengths and areas for improvement. An initial 3-month pilot was conducted where PESs were available on a self-serve basis to patients and caregivers in waiting areas and at radiation therapy treatment units. All responses were anonymous and completed surveys were returned via drop boxes. Descriptive statistics and thematic analysis were used to analyse responses. RESULTS: A total of 86 surveys were returned. Of those, 80 (93%) responded to the Likert scale question with 83% agreeing or strongly agreeing that their experience in radiation therapy was great. Several strengths were identified by respondents including teamwork, professionalism, and knowledge. Areas identified for improvement included management of appointment delays and communication of delays to patients, as well as environmental improvements. CONCLUSIONS: Although most respondents reported a favourable experience, this pilot demonstrated the minute survey can identify areas for improvement that can be addressed through QI. Including the patient perspective in QI is evidenced to enhance its outcome and aligns with institutional, provincial, and national strategic goals of improving the quality of cancer care through patient engagement.

Optimized penile surface mold brachytherapy using latest stereolithography techniques: A single-institution experience.

PURPOSE: To describe a technique of penile surface mold high-dose-rate (HDR) brachytherapy and early outcomes. METHODS AND MATERIALS: Five patients diagnosed with a T1aN0 squamous cell carcinoma of the penis were treated using a penile surface mold HDR brachytherapy technique. A negative impression of the penis was obtained using dental alginate. CT images were acquired of the penile impression; subsequently, a virtual model of the patient's penis was generated. The positive model was imported into a computer-assisted design program where catheter paths were planned such that an optimized offset of 5 mm from the penile surface was achieved. The virtual model was converted into a custom applicator. A total dose of 40 Gy was delivered in 10 fractions. Patients were followed at 1, 3, 6, and 12 months after treatment and then every 6 months thereafter. Toxicities were reported using Common Terminology Criteria for Adverse Events v4.0. RESULTS: All patients tolerated treatment well. Acute Grade 2 skin reactions were observed within the first month after treatment. Median followup was 35 months. Late Grade 1 skin toxicities were observed. One patient experienced a urethral stricture requiring dilatation. Two patients developed local recurrence. CONCLUSION: This technique allows the delivery of penile HDR brachytherapy as an outpatient procedure with minimal discomfort to the patient during each application and is a repeatable and accurate setup. This technique warrants validation in larger series with longer followup.

Best practices on team communication: interprofessional practice in oncology.

PURPOSE OF REVIEW: Good communication is the cornerstone of interprofessional care teams providing optimized quality patient care. Over the last decade, advances in technology have provided tools to improve communication; however, opportunities still exist for innovation and implementation. RECENT FINDINGS: The literature suggests that interprofessional education and assessment of team communication are fundamental in supporting collaborative care. The literature favours an interactive, team-based approach (e.g. simulation) to learning about communication, in which communication competencies and behaviours are practiced explicitly in an open, feedback-rich environment. SUMMARY: Key elements of excellence in communication are embedded in three priority recommendations: first, the team must adopt a practice strategy that leverages accessible and timely communication second, the team must be open to initial and ongoing training within the domain of 'effective communication' third, communication must be the cornerstone to producing a high-performing team that will provide the best care possible.

A prospective analysis of catheter complications for gynecological cancers treated with interstitial brachytherapy in the 3D era.

PURPOSE: Perineal interstitial brachytherapy (P-ISBT) is an important component in the treatment of locally advanced gynecological cancers. However, there are concerns about potential acute complications from catheter needles. The goal is to evaluate the safety of P-ISBT by studying acute complications and radiological organ needle intrusions. MATERIALS AND METHODS: Forty-eight patients with gynecological cancers treated with P-ISBT at a single institution from September 2014 to April 2016 were included in a prospective registry trial. Postoperative adverse events were recorded during inpatient stay and at 6-week followup. Postprocedure CT and MRI images were reviewed by two physicians to record the number of needles intruded into organs. Discrepancies were resolved by a radiologist. RESULTS: Median followup time was at least 3 months. Forty-two patients were initially treated with external beam radiation therapy, median dose of 45 Gy. A total of 73 insertions were performed. The median number of needles for first and second insertions was 17 and 19, respectively. Twenty-eight patients had radiological evidence of needle intrusion(s) into at least one pelvic organ. The most commonly intruded organs were large bowel (18 cases) and bladder (18), followed by rectum (12). A total of nine acute toxicities from needle intrusions were found: four hematuria (1 G1, 3 G2); four perineal infections (3 G2, 1 G3); and one vaginal bleeding (G3). No gastrointestinal complications were found. CONCLUSIONS: Perineal ISBT is an effective treatment for gynecological cancers. Despite occasional radiological catheter intrusions, there are low rates of organ complications. Concern of needle complications from P-ISBT should not be a barrier to adopting this technique for effective treatment.

SABR in High-Risk Prostate Cancer: Outcomes From 2 Prospective Clinical Trials With and Without Elective Nodal Irradiation.

PURPOSE: There is limited data on stereotactic ablative radiation therapy (SABR) in high-risk prostate cancer (PCa), especially regarding the role of elective nodal irradiation (ENI). This study compares 2 prospective phase 2 trials using SABR in high-risk PCa, with and without ENI. METHODS AND MATERIALS: Patients had high-risk PCa. Those in trial 1 received 40 Gy in 5 fractions to the prostate and 30 Gy in 5 fractions to the seminal vesicles. Patients in trial 2 received 40 Gy in 5 fractions to the prostate and 25 Gy in 5 fractions to the pelvis and seminal vesicles. National Cancer Institute Common Terminology Criteria for Adverse Events toxicities were collected. Biochemical failure (BF) was defined as nadir + 2, and the 4-year prostate-specific antigen (PSA) response rate (4yPSARR) was <0.4 ng/mL. RESULTS: Sixty patients were included (trial 1, n = 30; trial 2, n = 30). Median follow-up was 5.6 years and 4.0 years. The median nadir PSA was 0.02 ng/mL for both trials. Six patients had BF, all from trial 1. The BF rate was 14.6% at 5 years in trial 1 and 0% in trial 2. Sixty-three percent of patients in trial 1 and 93% in trial 2 had a 4yPSARR. Two patients died in trial 1, 1 from metastatic disease. One patient in trial 2 died of other causes. No other patients developed metastatic disease, and 1 patient in trial 1 had castrate resistant PCa. Overall survival at 5 years was 93.2% and 96.7% (P = .86). There was significantly worse late gastrointestinal and sexual toxicity in trial 1, but there was no difference in late genitourinary toxicity. CONCLUSIONS: SABR in high-risk PCa yields biochemical control rates that may be comparable to that of other radiation therapy modalities. ENI using SABR is feasible and may lead to a significant improvement in biochemical control and in 4yPSARR, without an increase in late gastrointestinal or genitourinary toxicity. Longer follow-up would provide a better assessment of biochemical control. Well-conducted phase 3 trials are needed to fully establish the role of SABR and ENI in high-risk PCa.

Assessing the Psychological Impact of Daily Bowel Preparation on Prostate Patients Who Receive Radiation Therapy.

PURPOSE: Evidence has shown that the prostate moves depending on filling of the rectum and, to a lesser extent, the bladder; many radiation therapy departments have adopted standardized bladder filling/rectal emptying protocols for radiotherapy treatment. Daily treatments may be delayed until appropriate volumes are attained; the resultant psychological impact of these delays on patients is unknown. The purpose of this study was to determine levels of anxiety, depression, distress, and bother related to bowel preparation for prostate cancer patients undergoing radiation therapy treatment. METHODS: A prospective cohort analysis of prostate cancer patients undergoing external beam radiation therapy was completed. Patients were assigned to one of three groups; Group A was standard of care, Group B was standard of care plus increased educational information regarding bowel preparation, Group C was standard of care plus increased educational information regarding bowel preparation plus an anti-flatulent medication. Hospital Anxiety and Depression Scale, Distress Thermometer, and a Bowel Status Bother survey were completed by participants at the start of theircourse of radiation treatment, mid-way through, and at the end. Analysis of variance testing was completed to determine differences in mean scores between the three groups. RESULTS: Mean age of patients (N = 30) was 66 years; 50% of the participants had a university education; 80% were married. Anxiety levels decreased over time in all groups (P = .039) with no difference between groups (P = 0.447). Depression levels across time for each group remained low (P = .577). Overall distress levels associated with bowel preparation were low among each group, and no significant differences were reported (P = .978). All groups reported high rates of quality of life. CONCLUSIONS: Findings from this study indicate that collectively across three groups and over time, there were low levels of anxiety, depression, and distress from bowel preparation. Amount, timing, quality, and approach to educational information are important factors to ensure patients feel prepared for their radiation therapy treatments.

Focal Salvage High Dose-Rate Brachytherapy for Locally Recurrent Prostate Cancer After Primary Radiation Therapy Failure: Results From a Prospective Clinical Trial.

PURPOSE: Although increasing data support whole-gland salvage therapy for recurrent prostate cancer, toxicity remains a significant concern. We hypothesized that focal therapy, treating only a portion of the prostate containing recurrent disease, might be equally effective and associated with less toxicity. The objectives of this prospective study were to explore the toxicities, quality of life, and efficacy of focal salvage high-dose-rate (HDR) brachytherapy in patients with multiparametric magnetic resonance imaging (MRI)-visible, biopsy-confirmed local recurrence after previous definitive external beam radiation therapy. MATERIALS AND METHODS: Fifteen patients with locally recurrent prostate cancer after external beam radiation therapy were enrolled in this prospective study. Patients were treated with ultrasound-based HDR brachytherapy with a prescription dose of 27 Gy divided in 2 implants, separated by 1 week, to the clinical target volume, which was defined as the quadrant of the prostate where the MRI-visible recurrent lesion was located. Toxicity, quality of life, and biochemical outcomes were analyzed. Postsalvage MRI was performed to assess radiation therapy response. RESULTS: Median follow-up was 36 months. The median size of the recurrence on MRI was 9 mm (range, 7-20 mm), and clinical target volume at the time of HDR was 6.1 mL (range, 2.2-16.1 mL). Only one grade 3 genitourinary toxicity event was observed. No urinary retention was observed. Three-year prostate-specific antigen failure-free rate was 61%. There was no significant change in Expanded Prostate Cancer Index Composite urinary or bowel domains over time. Of the 14 patients who had a post-HDR MRI, 12 had a treatment response. CONCLUSIONS: Our results suggest that focal salvage HDR brachytherapy is well tolerated and promising. External validation is needed.

Phase 1-2 Study of Stereotactic Ablative Radiotherapy Including Regional Lymph Node Irradiation in Patients With High-Risk Prostate Cancer (SATURN): Early Toxicity and Quality of Life.

PURPOSE: Five-fraction stereotactic ablative radiation therapy appears to be gaining popularity in treatment of prostate cancer, but it has not been extensively tested in the context of pelvic radiation. The objective of this prospective prostate and pelvic SABR study is to report the acute toxicity, late toxicity, and quality of life (QoL) after study completion. METHODS AND MATERIALS: A phase 1/2 study was conducted for patients with high-risk prostate cancer. Radiation therapy was planned to deliver 25 Gy to pelvis and seminal vesicles (SV) and a simultaneous integrated boost (SIB) of up to 40 Gy to the prostate in 5 fractions, weekly, over 29 days. Androgen deprivation therapy was used for 12 to 18 months. Common Terminology Criteria for Adverse Events version 3.0 was used to assess worst acute and late toxicities. QoL data was captured using the Expanded Prostate Cancer Index Composite questionnaire (EPIC). RESULTS: Thirty patients completed the planned treatment with a median follow-up of 25.7 months (range, 18.5-30.7 months). The following "worst" acute and late toxicities were observed: grade 2 genitourinary toxicity, 46.7% and 52%, respectively; grade 2 gastrointestinal toxicity, 3.3% and 32%, respectively. No grade 3 or higher toxicities were noted. Mean (95% confidence interval) EPIC urinary QoL scores were 86.6 (81.9-91.3), 87.1 (81.4-92.6), and 87.9 (80.1-95.7) at baseline, 3 months and 24 months; bowel scores were 94.1 (91.3-97.0), 93.2 (89.1-97.2), and 92.4 (87.7- 97.1), respectively. CONCLUSIONS: This gantry-based novel fractionation schedule incorporating pelvic radiation for high-risk prostate cancer in combination with androgen deprivation therapy is feasible and well tolerated.

Dose escalation for prostate stereotactic ablative radiotherapy (SABR): Late outcomes from two prospective clinical trials.

PURPOSE: Optimal prostate SABR dose-fractionation is unknown. This study compares long-term outcomes from two prospective trials. METHODS: Study1 patients had low-risk PCa and received 35 Gy/5. Study2 patients had low/intermediate-risk PCa and received 40 Gy/5. Biochemical failure (BF) was defined as nadir + 2. RESULTS: 114 patients were included (study1, n = 84; study2, n = 30). Median follow-up was 9.6 years and 6.9 years. Median nPSA was 0.4 and 0.1 ng/ml. Nine patients had BF (8 in study1, 1 in study2); two were managed with ADT and four had local salvage. The BF rate was 2.5% and 12.8% at 5 and 10 years for study1 and 3.3% at 5 years for study 2. BF probability was 0% if PSA <0.4 at 4 years, and 20.5% at 10 years if PSA ≥0.4 (p = 0.02). Nine patients died, none of PCa. No patient has metastases or castrate-resistance. At 10 years, OS and CSS were 90.4% (p = 0.25) and 100%. CONCLUSIONS: Dose-escalated prostate SABR was associated with lower nPSAs but no difference in BF, OS, CSS or MFS. PSA <0.4 at 4 years was a predictor of biochemical control. Half of patients with BF were successfully salvaged. Given that this is a favorable-risk cohort, longer follow-up will be needed to see if the lower nPSA translates into lower BF rates.

To prep or not to prep - that is the question: A randomized trial on the use of antiflatulent medication as part of bowel preparation for patients having image guided external beam radiation therapy to the prostate.

INTRODUCTION: Radiation therapy is a standard treatment option for prostate cancer. With growing use of escalated doses and tighter margins, procedures to limit rectal size variation are needed to reduce prostate motion, increase treatment accuracy, and minimize rectal toxicity. This prospective study was done to determine whether the introduction of an antiflatulent medication would decrease rectal distention at computed tomography (CT) simulation and throughout a course of radiation therapy. METHODS AND MATERIALS: Patients undergoing a radical course of radiation therapy to the prostate/prostate bed were eligible to participate. Participants were randomly assigned to the intervention arm (antiflatulent medication) or the control arm (no medication). For each participant, the number of CT simulation rescans was recorded. Rectal diameters were measured on CT simulation and treatment cone beam CT scans. Acute rectal toxicities were assessed at baseline and weekly using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE), version 4.0. A χ2 analysis was used to compare the number of participants requiring a rescan in each study arm. Change in rectal diameter over time was assessed using repeated measures analysis of variance. RESULTS: A total of 78 patients participated, with equal numbers assigned to each study arm. There was no significant difference between arms in the number of participants requiring a CT simulation rescan (P = .5551). There was no significant variation in rectal diameter between arms (P = .8999); however, there was a significant effect of time (P = .0017) and a significant interaction effect between study arm and time on rectal diameter (P = .0141). No acute rectal toxicities above grade 2 were reported. CONCLUSIONS: The addition of antiflatulent medication did not affect the frequency of CT simulation rescans. Both time and the interaction between study arm and time had a statistically significant effect on rectal diameter, although neither finding was clinically significant. Instead, standardized bowel preparation education developed for this study may have been sufficient to limit rectal size variation.

Dosimetric impact of inter-observer catheter reconstruction variability in ultrasound-based high-dose-rate prostate brachytherapy.

PURPOSE: To investigate the dosimetric impact of interobserver catheter reconstruction variability in transrectal ultrasound-guided prostate high-dose-rate (HDR) brachytherapy. METHODS AND MATERIALS: Twenty consecutive patients with intermediate- or high-risk prostate cancer were treated with a single, 15-Gy HDR brachytherapy boost as part of this study. The treated plan was used as the study reference plan (PR). Three expert treatment planners (observers) manually reconstructed the catheter paths on the static three-dimensional transrectal ultrasound images, and new plans were generated from the updated positions (POBS); subsequently, the dwell time and positions from the POBS plans were superimposed on the PR catheter paths to evaluate the dosimetric effect of the interobserver variations (PEVAL). Plans from each group were stratified by observer and by number of catheters (12 or 16) and then compared using a one-way Kruskal-Wallis H test with post hoc Mann-Whitney U tests reserved for significant variations (α = 0.05). RESULTS: Greater than 98.9% of catheter reconstruction variations were <3 mm. When stratified by observer, there was a significant decrease (p << 0.05) in planning target volume (PTV) V100% and increases in the urethral Dmax between the POBS plans propagated to the PR catheter paths and dosimetry evaluated and PR plans only. Stratification of plans by catheter number showed nonclinically significant decreases in PTV V100%, and D90% and increases in urethral Dmax for the 12-catheter plans. CONCLUSIONS: Limiting interobserver variability, and its effects on prostate HDR brachytherapy plan quality, is critical to achieving good dosimetric outcomes; small variations in catheter reconstruction may translate to inadequate PTV coverage, excessive urethral dose, or both.