What can patient-reported experience measures tell us about the variation in patients' experience of prostate cancer care? A cross-sectional study using survey data from the National Prostate Cancer Audit in England.

OBJECTIVES: A national survey aimed to measure how men with prostate cancer perceived their involvement in and decisions around their care immediately after diagnosis. This study aimed to describe any differences found by socio-demographic groups. DESIGN: Cross-sectional study of men who were diagnosed with and treated for prostate cancer. SETTING: The National Prostate Cancer Audit patient-reported experience measures (PREMs) survey in England. PARTICIPANTS: Men diagnosed in 2014-2016, with non-metastatic prostate cancer, were surveyed. Responses from 32 796 men were individually linked to records from a national clinical audit and to administrative hospital data. Age, ethnicity, deprivation and disease risk classification were used to explore variation in responses to selected questions. PRIMARY AND SECONDARY OUTCOME MEASURES: Responses to five questions from the PREMs survey: the proportion responding to the highest positive category was compared across the socio-demographic characteristics above. RESULTS: When adjusted for other factors, older men were less likely than men under the age of 60 to feel side effects had been explained in a way they could understand (men 80+: relative risk (RR)=0.92, 95% CI 0.84 to 1.00), that their views were considered (RR=0.79, 95% CI 0.73 to 0.87) or that they were involved in decisions (RR=0.92, 95% CI 0.85 to 1.00). The latter was also apparent for men who were not white (black men: RR=0.89, 95% CI 0.82 to 0.98; Asian men: RR=0.85, 95% CI 0.75 to 0.96) and, to a lesser extent, for more deprived men. CONCLUSIONS: The observed discrepancies highlight the need for more focus on initiatives to improve the experience of ethnic minority patients and those older than 60 years. The findings also argue for further validation of discriminatory instruments to help cancer care providers fully understand the variation in the experience of their patients.

Does Research from Clinical Trials in Metastatic Hormone-sensitive Prostate Cancer Treatment Translate into Access to Treatments for Patients in the "Real World"? A Systematic Review.

CONTEXT: Since 2015 there have been major advances in the management of primary metastatic hormone-sensitive prostate cancer (mHSPC) following the publication of key clinical trials that demonstrated significant clinical benefits with docetaxel chemotherapy or novel hormone therapy (NHT) in addition to androgen deprivation therapy (ADT). Despite these advances, there is evidence to show that these treatments are not being utilised for mHSPC in clinical practice. OBJECTIVE: To determine the utilisation of docetaxel and NHT in mHSPC in routine practice and the determinants of variation in their use. EVIDENCE ACQUISITION: MEDLINE and Embase were searched systematically for studies on utilisation of treatments for primary mHSPC that were based on regional or national data sets and published after January 2005. Study results were summarised using a narrative synthesis. EVIDENCE SYNTHESIS: Thirteen papers were included in the analysis, six full-text articles and seven abstracts, on studies that included a total of 166 876 patients. The utilisation rate of treatment intensification with either docetaxel or NHT (enzalutamide, apalutamide, or abiraterone) in addition to ADT ranged from 9.3% to 38.1% across the studies. Younger, White patients with fewer comorbidities and living in more urban settings were more likely to be prescribed treatment intensification. Patients treated in private academic institutions by oncologists were more likely to receive docetaxel or NHT. Socioeconomic status did not impact receipt of systemic therapy. NHT utilisation rates appear to have increased over time. CONCLUSIONS: These results highlight the need to change the approach to the treatment of primary mHSPC in the real world by harnessing the practice-changing results from recent trials in this setting to optimise upfront systemic therapy for this patient population. PATIENT SUMMARY: We reviewed the use of treatments for primary metastatic hormone-sensitive prostate cancer that showed a benefit in key clinical trials. We found that these treatments are underused, particularly among certain patient groups.

Organisation and delivery of supportive services for patients with prostate cancer in the National Health Service in England and Wales: a national cross-sectional hospital survey and latent class analysis.

OBJECTIVES: We assessed how often National Health Service (NHS) hospitals reported that they had specific supportive services for patients with prostate cancer available onsite, including nursing support, sexual function and urinary continence services, psychological and genetic counselling, and oncogeriatric services. We identified groups of hospitals with similar patterns of supportive services. DESIGN/SETTING: We conducted an organisational survey in 2021 of all NHS hospitals providing prostate cancer services in England and Wales. Latent class analysis grouped hospitals with similar patterns of supportive services. RESULTS: In 138 hospitals, an advanced prostate cancer nurse was available in 125 hospitals (90.6%), 107 (77.5%) had a clinical nurse specialist (CNS) attending all clinics, 103 (75.7%) had sexual function services, 111 (81.6%) had continence services and 93 (69.4%) psychological counselling. The availability of genetic counselling (41 hospitals, 30.6%) and oncogeriatric services (15 hospitals, 11.0%) was lower. The hospitals could be divided into three groups. The first and largest group of 85 hospitals provided the most comprehensive supportive services onsite: all hospitals had a CNS attending all clinics, 84 (98.8%) sexual function services and 73 (85.9%) continence services. A key characteristic of the second group of 31 hospitals was that none had a CNS attending all clinics. A key characteristic of the third group of 22 hospitals was that none had sexual function services available. The hospitals in the largest group were more likely to run joint clinics (p<0.001) and host the regional specialist multidisciplinary team (p=0.002). CONCLUSIONS: There is considerable variation in supportive services for prostate cancer available onsite in NHS hospitals in England and Wales. Availability of genetic counselling and oncogeriatric services is low. The different patterns of supportive services among hospitals demonstrate that initiatives to improve the availability of the entire range of supportive services to all patients should be carefully targeted.

Prostate cancer outcomes following whole-gland and focal high-intensity focused ultrasound.

OBJECTIVE: To report the 5-year failure-free survival (FFS) following high-intensity focused ultrasound (HIFU). PATIENTS AND METHODS: This observational cohort study used linked National Cancer Registry data, radiotherapy data, administrative hospital data and mortality records of 1381 men treated with HIFU for clinically localised prostate cancer in England. The primary outcome, FFS, was defined as freedom from local salvage treatment and cancer-specific mortality. Secondary outcomes were freedom from repeat HIFU, prostate cancer-specific survival (CSS) and overall survival (OS). Cox regression was used to determine whether baseline characteristics, including age, treatment year, T stage and International Society of Urological Pathology (ISUP) Grade Group were associated with FFS. RESULTS: The median (interquartile range [IQR]) follow-up was 37 (20-62) months. The median (IQR) age was 65 (59-70) years and 81% had an ISUP Grade Group of 1-2. The FFS was 96.5% (95% confidence interval [CI] 95.4%-97.4%) at 1 year, 86.0% (95% CI 83.7%-87.9%) at 3 years and 77.5% (95% CI 74.4%-80.3%) at 5 years. The 5-year FFS for ISUP Grade Groups 1-5 was 82.9%, 76.6%, 72.2%, 52.3% and 30.8%, respectively (P < 0.001). Freedom from repeat HIFU was 79.1% (95% CI 75.7%-82.1%), CSS was 98.8% (95% CI 97.7%-99.4%) and OS was 95.9% (95% CI 94.2%-97.1%) at 5 years. CONCLUSION: Four in five men were free from local salvage treatment at 5 years but treatment failure varied significantly according to ISUP Grade Group. Patients should be appropriately informed with respect to salvage radical treatment following HIFU.

Treatment-related toxicity using prostate bed versus prostate bed and pelvic lymph node radiation therapy following radical prostatectomy: A national population-based study.

Purpose There is debate about the effectiveness and toxicity of pelvic lymph node (PLN) irradiation in addition to prostate bed radiotherapy when used to treat disease recurrence following radical prostatectomy. We compared toxicity from radiation therapy (RT) to the prostate bed and pelvic lymph nodes (PBPLN-RT) with prostatebed only radiation therapy (PBO-RT) following radical prostatectomy. Methods and Materials Patients with prostate cancer who underwent post-prostatectomy RT between 2010 and 2016 were identified by using the National Prostate Cancer Audit (NPCA) database. Follow-up data was available up to December 31, 2018. Validated outcome measures, based on a framework of procedural and diagnostic codes, were used to capture ≥Grade 2 gastrointestinal (GI) and genitourinary (GU) toxicity. An adjusted competing-risks regression analysis estimated subdistribution hazard ratios (sHR). A sHR > 1 indicated a higher incidence of toxicity with PBPLN-RT than with PBO-RT. Results 5-year cumulative incidences in the PBO-RT (n = 5,087) and PBPLNRT (n = 593) groups was 18.2% and 15.9% for GI toxicity, respectively. For GU toxicity it was 19.1% and 20.7%, respectively. There was no evidence of difference in GI or GU toxicity after adjustment between PBO-RT and PBPLN-RT (GI: adjusted sHR, 0.90, 95% CI, 0.67-1.19; P = 0.45); (GU: adjusted sHR, 1.19, 95% CI, 0.99-1.44; P = 0.09). Conclusions This national population-based study found that including PLNs in the radiation field following radical prostatectomy is not associated with a significant increase in rates of ≥Grade 2 GI or GU toxicity at 5 years.

A low prostate specific antigen predicts a worse outcome in high but not in low/intermediate-grade prostate cancer.

OBJECTIVE: The relationship between prostate-specific antigen (PSA) and prostate cancer (PCa) grade was traditionally thought to be linear but recent reports suggest this is not true in high-grade cancers. We aimed to compare the association between PSA and PCa-specific mortality (PCSM) in clinically localised low/intermediate and high-grade PCa. SUBJECTS/PATIENTS AND METHODS: Retrospective cohort study using the National Prostate Cancer Audit database in England of men treated with external beam radiotherapy (EBRT), EBRT and brachytherapy boost (EBRT + BT), radical prostatectomy or no radical local treatment between 2014 and 2018. Multivariable competing-risk regression was used to examine the association between PSA, Gleason, and PCSM. Multivariable restricted cubic spline regression was used to explore the non-linear associations of PSA and PCSM. RESULTS: 102,089 men were included, of whom 71,138 had low/intermediate-grade and 22,425 had high-grade PCa. In high-grade, 4-year PCSM was higher with PSA ≤5 than PSA 5.1-10 for men treated with EBRT (hazard ratio 1.96 (95% confidence interval 1.15-3.34) or no radical local treatment (hazard ratio 1.99 (95% confidence interval 1.33-2.98). Restricted cubic spline regression showed that PSA and PCSM have a non-linear association in high-grade but a linear association in low/intermediate-grade PCa. CONCLUSION: The low-PSA/high-grade combination in M0 PCa treated with EBRT has a higher PCSM than those with high-grade and intermediate PSA levels. In high-grade disease, the PSA association was non-linear; by contrast, low/intermediate-grade had a linear relationship. This confirms a more aggressive biology in low PSA secreting high-grade PCa and a worse outcome following treatment.

Hospital volume and outcomes after radical prostatectomy: a national population-based study using patient-reported urinary continence and sexual function.

BACKGROUND: Improvements in short-term outcomes have been reported for hospitals with higher radical prostatectomy (RP) volumes. However, the association with longer-term functional outcomes is unknown. METHODS: All patients diagnosed with non-metastatic prostate cancer in the English NHS between 2014 and 2016 who underwent RP (N = 10,089) were mailed a survey ≥18 months after diagnosis. Differences in patient-reported urinary continence and sexual function (EPIC-26 on scale from 0 to 100) by hospital volume group (≤60, 61-100, 101-140, >140 RPs/year) were estimated using multilevel linear regression. RESULTS: Overall, 7702 men (76.3%) responded. There were no statistically significant differences in urinary continence (p = 0.08) or sexual function scores with increasing volume group (p = 0.2). When modelled as a linear function, we found a non-significant increase of 0.70 (95% CI -0.41 to 1.80; p = 0.22) in urinary continence and a significant increase of 1.54 (0.62-2.45; p = 0.001) in sexual function scores for a 100-procedure increase in hospital volume, which did not meet the threshold for a minimal clinically important difference (10-12 points). The results were similar for robotic-assisted RP (5529 men [71.8%]). CONCLUSIONS: These results do not support further centralisation of RP services beyond levels in England where four in five hospitals perform >60 RPs/year.

Determinants of variation in radical local treatment for men with high-risk localised or locally advanced prostate cancer in England.

BACKGROUND: Many factors are implicated in the potential 'under-treatment' of prostate cancer but little is known about the between-hospital variation. METHODS: The National Prostate Cancer Audit (NPCA) database was used to identify high-risk localised or locally advanced prostate cancer patients in England, between January 2014 and December 2017, and the treatments received. Hospital-level variation in radical local treatment was explored visually using funnel plots. The intra-class correlation coefficient (ICC) quantified the between-hospital variation in a random-intercept multivariable logistic regression model. RESULTS: 53,888 men, from 128 hospitals, were included and 35,034 (65.0%) received radical local treatment. The likelihood of receiving radical local treatment was increased in men who were younger (the strongest predictor), more affluent, those with fewer comorbidities, and in those with a non-Black ethnic background. There was more between-hospital variation (P < 0.001) for patients aged ≥80 years (ICC: 0.235) compared to patients aged 75-79 years (ICC: 0.070), 70-74 years (ICC: 0.041), and <70 years (ICC: 0.048). Comorbidity and socioeconomic deprivation did not influence the between-hospital variation. CONCLUSIONS: Radical local treatment of high-risk localised or locally advanced prostate cancer depended strongly on age and comorbidity, but also on socioeconomic deprivation and ethnicity, with the between-hospital variation being highest in older patients.

Comparison of the treatment of men with prostate cancer between the US and England: an international population-based study.

INTRODUCTION: The treatment of prostate cancer varies between the United States (US) and England, however this has not been well characterised using recent data. We therefore investigated the extent of the differences between US and English patients with respect to initial treatment. METHODS: We used the Surveillance, Epidemiology, and End Results (SEER) database to identify men diagnosed with prostate cancer in the US and the treatments they received. We also used the National Prostate Cancer Audit (NPCA) database for the same purposes among men diagnosed with prostate cancer in England. Next, we used multivariable regression to estimate the adjusted risk ratio (aRR) of receiving radical local treatment for men with non-metastatic prostate cancer according to the country of diagnosis (US vs. England). The five-tiered Cambridge Prognostic Group (CPG) classification was included as an interaction term. RESULTS: We identified 109,697 patients from the SEER database, and 74,393 patients from the NPCA database, who were newly diagnosed with non-metastatic prostate cancer between April 1st 2014 and December 31st 2016 with sufficient information for risk stratification according to the CPG classification. Men in the US were more likely to receive radical local treatment across all prognostic groups compared to men in England (% radical treatment US vs. England, CPG1: 38.1% vs. 14.3% - aRR 2.57, 95% CI 2.47-2.68; CPG2: 68.6% vs. 52.6% - aRR 1.27, 95% CI 1.25-1.29; CPG3: 76.7% vs. 67.1% - aRR 1.12, 95% CI 1.10-1.13; CPG4: 82.6% vs. 72.4% - aRR 1.09, 95% CI 1.08-1.10; CPG5: 78.2% vs. 71.7% - aRR 1.06, 95% CI 1.04-1.07) CONCLUSIONS: Treatment rates were higher in the US compared to England raising potential over-treatment concerns for low-risk disease (CPG1) in the US and under-treatment of clinically significant disease (CPG3-5) in England.

Practicalities, challenges and solutions to delivering a national organisational survey of cancer service and processes: Lessons from the National Prostate Cancer Audit.

Organisational surveys are a critical process to assess the configuration and availability of services within health care systems. Cancer service organizational surveys enable understanding of variation in structure, processes and outcomes of cancer care according to the availability of facilities and their geographical organisation. This is critical for evaluating the delivery of cancer care services across a specified region. Furthermore, the organisational survey provides essential information about patient support services which can be used to inform patients where particular allied health services are available. The National Prostate Cancer Audit (NPCA) is an audit of all prostate cancer services in England and Wales. The NPCA encompasses all prostate cancer diagnostics, treatments (including surgery, radiotherapy and systemic therapy) and allied services. The NPCA conducted an organisational survey in 2021 via an online questionnaire sent to the prostate cancer clinical leads within each of the 138 NHS providers and we had a response rate of 93 %. There are many challenges to conducting an organisational survey and gaining a high completion rate is still difficult. The challenges that the NPCA faced included accuracy, completion, duplicates and discrepancies in responses. From this experience, we have developed some suggestions for the practical delivery and development of future organisational surveys. It was thanks to the use of many of these strategies, and the engagement of clinicians with the NPCA, that we were able to achieve such a high response rate. Despite these challenges, the importance of organisational surveys of cancer services is demonstrated by the better understanding of structure, processes and outcomes of cancer care according to the accessibility of facilities and their geographical organisation. This is essential for evaluating and improving the delivery of cancer care services across a region.

Interventions for obstructive uropathy in advanced prostate cancer: a population-based study.

OBJECTIVES: To develop and validate a coding framework to identify interventions for upper tract obstructive uropathy (UTOU) in men with locally advanced and metastatic prostate cancer (PCa) using administrative hospital data to assess clinical outcomes. There are no population-based studies on the incidence, treatment, and outcomes of this complication. PATIENTS AND METHODS: Patients newly diagnosed with PCa between April 2014 and March 2019 were identified in the English cancer registry. A coding framework based on procedure (Office of Population Censuses and Surveys Classification of Surgical Operations and Procedures fourth edition) and diagnostic (International Classification of Diseases, 10th edition) codes was developed and validated. Subsequent clinical outcomes were determined using Hospital Episodes Statistics to determine the utility of the intervention. RESULTS: A total of 77 010 patients newly diagnosed with locally advanced, and 30 083 patients with metastatic PCa were identified. Of these, 1951 (1.8%) patients underwent an intervention for UTOU according to our coding framework: 830 (42.5%) had locally advanced disease and 1121 (57.5%) had metastatic disease. In all, 844 (43.3%) had a percutaneous nephrostomy (PCN), 473 (24.2%) had a PCN with antegrade stent, and 634 (32.5%) had a retrograde stent. The mean follow-up was 43.2 months. The cumulative incidence of the use of these interventions at 1, 3, and 5 years was 2.5%, 3.6% and 4.2% in men with metastases compared to 0.5%, 0.9% and 1.4% in men with locally advanced disease. CONCLUSION: A new coding framework, developed to identify procedures for UTOU was applied in the largest study to date of UTOU in men with primary locally advanced and metastatic PCa. Results demonstrated that 2% of men with locally advanced PCa and 4% of men with metastatic PCa require an intervention to resolve UTOU within 5 years of their PCa diagnosis.

Implementation of patient-reported outcome measures into health care for men with localized prostate cancer.

Measuring treatment-related quality of life (QOL) has become an increasingly requisite component of delivering high-quality care for patients with prostate cancer. Patient-reported outcome measures (PROMs) have, therefore, become an important tool for understanding the adverse effects of radical prostate cancer treatment and have been widely integrated into clinical practice. By providing real-time symptom monitoring and improved clinical feedback to patients and providers, PRO assessment has led to meaningful gains in prostate cancer care delivery and quality improvement worldwide. By providing an avenue for benchmarking, collaboration and population health monitoring, PROMs have delivered substantial improvements beyond providing individual symptom feedback. However, multilevel barriers exist that need to be addressed before the routine implementation of PROMs is achieved. Improvements in collection, interpretation, standardization and reporting will be crucial for the continued implementation of PROM instruments in prostate cancer pathways.

Impact of the COVID-19 pandemic on the diagnosis and treatment of men with prostate cancer.

OBJECTIVE: To determine the impact of the COVID-19 pandemic on diagnostic and treatment activity in 2020 across hospital providers of prostate cancer (PCa) care in the English National Health Service. METHODS: Diagnostic and treatment activity between 23 March (start of first national lockdown in England) and 31 December 2020 was compared with the same calendar period in 2019. Patients newly diagnosed with PCa were identified from national rapid cancer registration data linked to other electronic healthcare datasets. RESULTS: There was a 30.8% reduction (22 419 vs 32 409) in the number of men with newly diagnosed PCa in 2020 after the start of the first lockdown, compared with the corresponding period in 2019. Men diagnosed in 2020 were typically at a more advanced stage (Stage IV: 21.2% vs 17.4%) and slightly older (57.9% vs 55.9% ≥ 70 years; P < 0.001). Prostate biopsies in 2020 were more often performed using transperineal (TP) routes (64.0% vs 38.2%). The number of radical prostatectomies in 2020 was reduced by 26.9% (3896 vs 5331) and the number treated by external beam radiotherapy (EBRT) by 14.1% (9719 vs 11 309). Other changes included an increased use of EBRT with hypofractionation and reduced use of docetaxel chemotherapy in men with hormone-sensitive metastatic PCa (413 vs 1519) with related increase in the use of enzalutamide. CONCLUSION: We found substantial deficits in the number of diagnostic and treatment procedures for men with newly diagnosed PCa after the start of the first lockdown in 2020. The number of men diagnosed with PCa decreased by about one-third and those diagnosed had more advanced disease. Treatment patterns shifted towards those that limit the risk of COVID-19 exposure including increased use of TP biopsy, hypofractionated radiation, and enzalutamide. Urgent concerted action is required to address the COVID-19-related deficits in PCa services to mitigate their impact on long-term outcomes.

Urinary incontinence and use of incontinence surgery after radical prostatectomy: a national study using patient-reported outcomes.

OBJECTIVES: To investigate whether patient-reported urinary incontinence (UI) and bother scores after radical prostatectomy (RP) result in subsequent intervention with UI surgery. PATIENTS AND METHODS: Men diagnosed with prostate cancer in the English National Health Service between April 2014 and January 2016 were identified. Administrative data were used to identify men who had undergone a RP and those who subsequently underwent a UI procedure. The National Prostate Cancer Audit database was used to identify men who had also completed a post-treatment survey. These surveys included the Expanded Prostate Cancer Composite Index (EPIC-26). The frequency of subsequent UI procedures, within 6 months of the survey, was explored according to EPIC-26 UI scores. The relationship between 'good' (≥75) or 'bad' (≤25) EPIC-26 UI scores and perceptions of urinary bother was also explored (responses ranging from 'no problem' to 'big problem' with respect to their urinary function). RESULTS: We identified 11 290 men who had undergone a RP. The 3-year cumulative incidence of UI surgery was 2.5%. After exclusions, we identified 5165 men who had also completed a post-treatment survey after a median time of 19 months (response rate 74%). A total of 481 men (9.3%) reported a 'bad' UI score and 207 men (4.0%) also reported that they had a big problem with their urinary function. In all, 47 men went on to have UI surgery within 6 months of survey completion (0.9%), of whom 93.6% had a bad UI score. Of the 71 men with the worst UI score (zero), only 11 men (15.5%) subsequently had UI surgery. CONCLUSION: In England, there is a significant number of men living with severe, bothersome UI after RP, and an unmet clinical need for UI surgery. The systematic collection of patient-reported outcomes could be used to identify men who may benefit from UI surgery.

Public reporting of outcomes in radiation oncology: the National Prostate Cancer Audit.

The public reporting of patient outcomes is crucial for quality improvement and informing patient choice. However, outcome reporting in radiotherapy, despite being a major component of cancer control, is extremely sparse globally. Public reporting has many challenges, including difficulties in defining meaningful measures of treatment quality, limitations in data infrastructure, and fragmented health insurance schemes. The National Prostate Cancer Audit (NPCA), done in the England and Wales National Health Service (NHS), shows that it is feasible to develop outcome indicators for radiotherapy treatment, including patient-reported outcomes. The NPCA provides a transparent mechanism for comparing the performance of all NHS providers, with results accessible to patients, providers, and policy makers. Using the NPCA as a case study, we discuss the development of a radiotherapy-outcomes reporting programme, its impact and future potential, and the challenges and opportunities to develop this approach across other tumour types and in different health systems.

Patient-reported functional outcomes following external beam radiation therapy for prostate cancer with and without a high-dose rate brachytherapy boost: A national population-based study.

BACKGROUND AND PURPOSE: Little is known about the functional outcomes and health-related quality of life (HRQoL) following external beam radiation therapy (EBRT) combined with a high-dose rate brachytherapy boost (EBRT-BB) for the treatment of prostate cancer. We aimed to compare patient-reported outcomes of EBRT to those of EBRT-BB. METHODS AND MATERIALS: Patients diagnosed with intermediate-risk, high-risk or locally advanced prostate cancer (April 2014 to September 2016), who received EBRT in the English National Health Service within 18 months of diagnosis and responded to a national patient questionnaire, were identified from the National Prostate Cancer Audit. Adjusted linear regression was used to estimate differences in functional EPIC-26 domains and HRQoL (EQ-5D-5L) between treatment groups. Non-inferiority of EBRT-BB was determined if the lower 95% confidence limit did not exceed the established minimal clinically important difference (MCID). RESULTS: Of the 13,259 included men, 12,503 (94.3%) received EBRT and 756 (5.7%) received EBRT-BB. EBRT-BB was non-inferior compared to EBRT for the urinary incontinence, sexual, bowel and hormonal EPIC-26 domains. EBRT-BB resulted in significantly worse urinary irritation/obstruction scores than EBRT (-6.1; 95% CI: -8.8 to -3.4) but uncertainty remains as to whether this difference is clinically important (corresponding MCID of 5). CONCLUSIONS: There is no evidence to suggest that EBRT-BB results in any clinically important detriment in functional outcomes or HRQoL compared to men receiving EBRT only. Whilst statistically significantly worse urinary irritation/obstruction outcomes were reported in the EBRT-BB cohort, the threshold for a clinically significant difference was not exceeded and further research is required for confirmation.

Impact of High-Dose-Rate and Low-Dose-Rate Brachytherapy Boost on Toxicity, Functional and Cancer Outcomes in Patients Receiving External Beam Radiation Therapy for Prostate Cancer: A National Population-Based Study.

PURPOSE: External beam radiation therapy (EBRT) with brachytherapy boost reduces cancer recurrence in patients with prostate cancer compared with EBRT monotherapy. However, randomized controlled trials or large-scale observational studies have not compared brachytherapy boost types directly. METHODS AND MATERIALS: This observational cohort study used linked national cancer registry data, radiation therapy data, administrative hospital data, and mortality records of 54,642 patients with intermediate-risk, high-risk, and locally advanced prostate cancer in England. The records of 11,676 patients were also linked to results from a national patient survey collected at least 18 months after diagnosis. Competing risk regression analyses were used to compare gastrointestinal (GI) toxicity, genitourinary (GU) toxicity, skeletal-related events (SRE), and prostate cancer-specific mortality (PCSM) at 5 years with adjustment for patient and tumor characteristics. Linear regression was used to compare Expanded Prostate Cancer Index Composite 26-item version domain scores (scale, 0-100, with higher scores indicating better function). RESULTS: Five-year GI toxicity was significantly increased after low-dose-rate brachytherapy boost (LDR-BB) (32.3%) compared with high-dose-rate brachytherapy boost (HDR-BB) (16.7%) or EBRT monotherapy (18.7%). Five-year GU toxicity was significantly increased after both LDR-BB (15.8%) and HDR-BB (16.6%), compared with EBRT monotherapy (10.4%). These toxicity patterns were matched by the mean patient-reported bowel function scores (LDR-BB, 77.3; HDR-BB, 85.8; EBRT monotherapy, 84.4) and the mean patient-reported urinary obstruction/irritation function scores (LDR-BB, 72.2; HDR-BB, 78.9; EBRT monotherapy, 83.8). Five-year incidences of SREs and PCSM were significantly lower after HDR-BB (2.4% and 2.7%, respectively) compared with EBRT monotherapy (2.8% and 3.5%, respectively). CONCLUSIONS: Compared with EBRT monotherapy, LDR-BB has worse GI and GU toxicity and HDR-BB has worse GU toxicity. HDR-BB has a lower incidence of SREs and PCSM than EBRT monotherapy.

Toxicity of Pelvic Lymph Node Irradiation With Intensity Modulated Radiation Therapy for High-Risk and Locally Advanced Prostate Cancer: A National Population-Based Study Using Patient-Reported Outcomes.

PURPOSE: Little is known about the toxicity of additional pelvic lymph node irradiation in men receiving intensity modulated radiation therapy (IMRT) for prostate cancer. The aim of this study was to compare patient-reported outcomes after IMRT to the prostate only (PO-IMRT) versus the prostate and pelvic lymph nodes (PPLN-IMRT). METHODS AND MATERIALS: Patients who received a diagnosis of high-risk or locally advanced prostate cancer in the English National Health Service between April 2014 and September 2016 who were treated with IMRT were mailed a questionnaire at least 18 months after diagnosis. Patient-reported urinary, sexual, bowel, and hormonal functional domains on a scale from 0 to 100, with higher scores indicating better outcomes, and generic health-related quality of life were collected using the Expanded Prostate Cancer Index Composite 26-item version and EQ-5D-5L. We used linear regression to compare PPLN-IMRT versus PO-IMRT with adjustment for patient, tumor, and treatment characteristics. RESULTS: Of the 7017 men who received a questionnaire, 5468 (77.9%) responded; 4196 (76.7%) had received PO-IMRT and 1272 (23.3%) PPLN-IMRT. Adjusted differences in the Expanded Prostate Cancer Index Composite 26-item version domain scores were smaller than 1 (P always >.2), except for sexual function, with men who had PPNL-IMRT reporting a lower mean score (adjusted difference, 2.3; 95% confidence interval, 0.9-3.7; P = .002). This did not represent a clinically relevant difference. There was no significant difference in health-related quality of life (P = .5). CONCLUSIONS: Additional pelvic lymph node irradiation does not lead to clinically meaningful increases in the toxicity of IMRT for prostate cancer according to patient-reported functional outcomes and health-related quality of life.