Expanded Prostate Cancer Index Composite Questionnaire Research Articles

Cs-131 prostate brachytherapy boost and effect of hydrogel rectal spacer on long-term patient-reported rectal bleeding and bowel quality of life

This study evaluates long-term patient-reported bowel quality of life (QOL), rectal bleeding, and bleeding bother in patients with prostate cancer treated with external beam radiation therapy (EBRT) and Cesium-131 LDR brachytherapy (LDR-BT) boost with and without hydrogel rectal spacer. This is a retrospective analysis of prostate cancer patients treated between 2007 and 2022 with 45 Gy EBRT followed by 85 Gy Cs-131 LDR-BT boost with or without hydrogel rectal spacer. Expanded Prostate Cancer Index Composite (EPIC) QOL questionnaires pre-treatment and at each follow-up were collected. Patient-reported rectal bleeding occurring more than "rarely" and bother from rectal bleeding occurring more than a "very small problem" were deemed clinically significant. Fisher's exact test was used to test the association of rectal spacer use and the incidence of clinically significant rectal bleeding and bleeding bother. Paired samples t-test was used to analyze mean bowel scores at each time point. Three hundred and forty-one patients were included in the analysis. The rectal spacer was used in 108 patients. Overall median follow-up was 48 months (IQR, 24-72), with a median follow-up of 24 months (IQR, 12-37.5) for the hydrogel group and 60 months (IQR, 36-84) for the non-hydrogel group. EPIC questionnaire response rates at median follow-up were 33% and 37% for the hydrogel and non-hydrogel groups, respectively. A clinically significant decrease in mean bowel domain scores was seen in the bowel bother domain at 6 and 12 months for patients who did not receive a rectal spacer. At the last follow-up of 60 months, the prevalence of clinically significant rectal bleeding and bleeding bother were 2.2% and 2.2%, respectively. The cumulative incidence of clinically significant long-term rectal bleeding was 2.8% and 18.9% in the hydrogel group and non-hydrogel group, respectively (Fisher's exact test, p < 0.0001). The cumulative incidence of clinically significant long-term bowel bother was 4.6% and 19.7% in the hydrogel group and non-hydrogel group, respectively (Fisher's exact test, p < 0.001). Use of hydrogel rectal spacer with EBRT and Cs-131 LDR-BT boost was significantly associated with a lower incidence of patient-reported rectal bleeding and bother from rectal bleeding, and better long-term bowel QOL. Cumulative incidence was 2.8% (hydrogel group) versus 18.9% (non-hydrogel group) and 4.6% (hydrogel group) versus 19.7% (non-hydrogel group) for clinically significant long-term rectal bleeding and long-term bleeding bother, respectively.

PSOR2 Presentation Time: 11:35 AM: Effect of SpaceOAR on Patient-Reported Rectal Bleeding Following External Beam Radiation Therapy and Cs-131 Prostate Brachytherapy Boost

<h3>Purpose</h3> To evaluate long-term patient reported rectal bleeding in patients with prostate cancer treated at our institution with and without SpaceOAR following external beam radiation therapy and Cesium-131 (131Cs) prostate LDR brachytherapy boost. <h3>Materials and Methods</h3> We started routinely offering SpaceOAR to patients treated with external beam radiation therapy and 131Cs prostate LDR brachytherapy boost from 2016 with goal of potentially reducing rectal toxicity, including late rectal bleeding. We analyzed patients treated with and without SpaceOAR with at least 6 months of follow-up, with treatment from January 2007 to February 2021. Patients were asked to fill out Expanded Prostate Cancer Index Composite (EPIC) QOL questionnaire pre-treatment and at each scheduled follow-up appointment. The EPIC questionnaire included the following categories related to rectal bleeding and bother from rectal bleeding. Rectal bleeding occurring more than "rarely" was deemed clinically significant and severe rectal bleeding was defined as occurring "usually" or "always". Clinically significant bother from rectal bleeding was defined as considering bleeding to be more than a "very small problem." Severe bother from rectal bleeding was defined as being a "moderate" or "big" problem. Univariate Cox regression was performed to assess for impact of SpaceOAR on incidence of clinically significant rectal bleeding, with censorship at maximum follow-up. <h3>Results</h3> 317 patients were included in the analysis, all of whom were treated with a combination of external beam radiation therapy and LDR brachytherapy boost. 172 patients (54.3%) had intermediate-risk prostate cancer, while 145 patients (45.7%) had high-risk disease. 157 patients (49.5%) received androgen deprivation therapy, while 160 patients (50.5%) did not. 87 patients (27.4%) underwent prostate LDR brachytherapy boost with SpaceOAR inserted in the operating room following completion of prostate seed implant, with remaining 230 patients (72.5%) treated without SpaceOAR. Median follow-up for patients who received SpaceOAR was 18 months (IQR 12-30 months), whereas median follow-up for patients who did not receive SpaceOAR was 54 months (IQR 36-72 months). Incidence of acute clinically significant rectal bleeding, occurring before 6 months, was 3.9% in the cohort treated without SpaceOAR and 3.4% in the cohort treated with SpaceOAR. Incidence of late clinically significant rectal bleeding was 19.6% without SpaceOAR and 0% with SpaceOAR. For patients who developed late clinically significant rectal bleeding, median time to development was 18 months (IQR 9-24 months). Prevalence of late clinically significant rectal bleeding at last follow-up was 3.5% without SpaceOAR. Incidence and prevalence of late severe rectal bleeding without SpaceOAR was 4.7% and 1.3%, respectively. Incidence of late clinically significant bother from rectal bleeding was 20% without SpaceOAR and 0% with SpaceOAR. Prevalence of late clinically significant bother from rectal bleeding at last follow-up was 4.3% without SpaceOAR. Incidence and prevalence of late severe bother from rectal bleeding without SpaceOAR was 10.9% and 2.2%, respectively. On univariate analysis, SpaceOAR utilization was significantly associated with reduction in incidence of clinically significant rectal bleeding (p=0.035, hazard ratio 0.033; 95% confidence interval 0.001-0.784). <h3>Conclusions</h3> Overall prevalence of late rectal bleeding following 131Cs LDR prostate brachytherapy at last follow-up was less than 5%. SpaceOAR was associated with lower incidence of clinically significant rectal bleeding occurring at 6 months post-treatment or later as assessed by the EPIC questionnaire. Given the lower median follow-up in the SpaceOAR group, additional follow-up is warranted to determine whether this reduction is maintained long-term.

A Prospective Study of Stereotactic Body Radiotherapy (SBRT) with Concomitant Whole-Pelvic Radiotherapy (WPRT) for High-Risk Localized Prostate Cancer Patients Using 1.5 Tesla Magnetic Resonance Guidance: The Preliminary Clinical Outcome.

Simple SummaryMagnetic resonance (MR)-guided stereotactic body radiotherapy (MRgSBRT) with concomitant whole-pelvic nodal radiotherapy (WPRT) represents a novel radiotherapy paradigm for high-risk prostate cancer (HR-PC), potentially improving online image guidance and clinical outcomes. This is the first prospective study aims to report the preliminary clinical experiences and treatment outcome of 1.5 Tesla adaptive MRgSBRT with concomitant WPRT in HR-PC patients (72.5 ± 6.8 years). Forty-two consecutive localized HR-PC patients were treated by online adaptive MRgSBRT (8 Gy(prostate)/5 Gy(WPRT) × 5 fractions) combined with androgen deprivation therapy (ADT) and followed up (median: 251 days, range: 20–609 days). The maximum cumulative acute gastrointestinal (GI)/ genitourinary (GU) grade 1 and 2 toxicity rates were 19.0%/81.0% and 2.4%/7.1%, respectively. The subacute (>30 days) GI/GU grade 1 and 2 toxicity rates were 21.4%/64.3% and 2.4%/2.4%, respectively. No grade 3 toxicities were reported. Patient-reported quality of life (QoL) showed insignificant changes in urinary, bowel, sexual, and hormonal domain scores during the follow-up period. All patients had early post-MRgSBRT biochemical responses, while biochemical recurrence (prostate-specific antigen nadir + 2 ng/mL) occurred in one patient at month 18. The early results suggested favorable treatment-related toxicities and encouraging patient-reported QoLs, but long-term follow-up is still needed. Background: Conventionally fractionated whole-pelvic nodal radiotherapy (WPRT) improves clinical outcome compared to prostate-only RT in high-risk prostate cancer (HR-PC). MR-guided stereotactic body radiotherapy (MRgSBRT) with concomitant WPRT represents a novel radiotherapy (RT) paradigm for HR-PC, potentially improving online image guidance and clinical outcomes. This study aims to report the preliminary clinical experiences and treatment outcome of 1.5 Tesla adaptive MRgSBRT with concomitant WPRT in HR-PC patients. Materials and methods: Forty-two consecutive HR-PC patients (72.5 ± 6.8 years) were prospectively enrolled, treated by online adaptive MRgSBRT (8 Gy(prostate)/5 Gy(WPRT) × 5 fractions) combined with androgen deprivation therapy (ADT) and followed up (median: 251 days, range: 20–609 days). Clinical outcomes were measured by gastrointestinal (GI) and genitourinary (GU) toxicities according to the Common Terminology Criteria for Adverse Events (CTCAE) Scale v. 5.0, patient-reported quality of life (QoL) with EPIC (Expanded Prostate Cancer Index Composite) questionnaire, and prostate-specific antigen (PSA) responses. Results: All MRgSBRT fractions achieved planning objectives and dose specifications of the targets and organs at risk, and they were successfully delivered. The maximum cumulative acute GI/GU grade 1 and 2 toxicity rates were 19.0%/81.0% and 2.4%/7.1%, respectively. The subacute (>30 days) GI/GU grade 1 and 2 toxicity rates were 21.4%/64.3% and 2.4%/2.4%, respectively. No grade 3 toxicities were reported. QoL showed insignificant changes in urinary, bowel, sexual, and hormonal domain scores during the follow-up period. All patients had early post-MRgSBRT biochemical responses, while biochemical recurrence (PSA nadir + 2 ng/mL) occurred in one patient at month 18. Conclusions: To our knowledge, this is the first prospective study that showed the clinical outcomes of MRgSBRT with concomitant WPRT in HR-PC patients. The early results suggested favorable treatment-related toxicities and encouraging patient-reported QoLs, but long-term follow-up is needed to confirm our early results.

The health-related quality of life in patients with prostate cancer managed with active surveillance using the Expanded Prostate Cancer Index Composite survey: Systematic review and meta-analysis

ABSTRACT Objective To examine the health-related quality of life (HRQoL) of patients with prostate cancer managed with active surveillance (AS) compared with those who receive definitive treatment using the Expanded Prostate Cancer Index Composite (EPIC) Survey. Methods We used the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines and searched PubMed and ScienceDirect for articles published between April 2010 and April 2020. Eligible studies reported original data on the HRQoL of men undergoing AS for prostate cancer, including studies comparing AS to curative methods particularly radical prostatectomy, radiotherapy, and brachytherapy. Results We identified nine eligible articles, all were non-experimental observational studies of which seven were longitudinal and two were cross-sectional studies. The EPIC questionnaire was the main instrument used in all studies to assess the HRQoL. AS was noted to show the highest calculated mean score among management groups in all comparative studies at study endpoints including cross-sectional studies (95% confidence interval 2.17–5.75, P < 0.001). The maximum score deterioration for patients who were managed with AS in all studies was only 7.5 points (12.2%) after 2 years follow-up. AS had the least mean score decline among all management groups. Patients with a normal testosterone level were found to have high HRQoL scores. The number of prostate biopsies did not correlate with the HRQoL score. Conclusion Patients with prostate cancer managed with AS report less impacts on their HRQoL compared to patients who receive definitive treatments. However, further high-quality research with long-term data are required to help both the patient and the physician in making a well-informed management decision.

Clinical use of expanded prostate cancer index composite-based health-related quality of life outcomes after robot-assisted radical prostatectomy for localized prostate cancer.

BackgroundThis study aimed to assess the longitudinal health-related quality of life (HRQOL) using the Expanded Prostate Cancer Index Composite (EPIC) and HRQOL change between the nerve-sparing technique in Japanese men treated with robot-assisted radical prostatectomy (RARP).MethodsA total of 573 patients who received RARP were included in this study. EPIC questionnaire was administered before treatment and up to 36 months after RARP. Clinical recovery was defined as half of the standard deviation of the baseline score for each domain. We divided all patients into recovery group or nonrecovery group. The time from survey to each domain recovery was calculated using the Kaplan–Meier method. We compared the sexual and urinary score change between groups using analysis of variance to confirm the effect of nerve-sparing technique.ResultsThe median age was 67 years (interquartile range, 62–71 years). The mean score of all urinary domains worsened noticeably after 1 month. All postoperative urinary summary, function, and incontinence scores were significantly lower than preoperative scores up to 3 years post-RARP. Postoperative sexual summary and functional scores were significantly lower than preoperative score at all follow-up times throughout the 36 months. The recovery rate for the urinary incontinence domain was the lowest (44.5%), whereas the recovery rate for the urinary irritative–obstructive domain was the highest (73.7%). In the sexual domain, the bother domain had a higher recovery rate (73.0%) than the functional domain (29.7%). Although the recovery of sexual domains was slower compared with other domains, by 36 months after RARP, almost all values had recovered. Compared with other technique groups, bilateral intrafascial nerve-sparing group showed significantly decreased change in subscale scores before and after RARP in several sexual and urinary domain.ConclusionThe time course and extent of functional and bother domain recovery documented in this study may prove useful for RARP patient selection in Japan.

Mapping expanded prostate cancer index composite to EQ5D utilities to inform economic evaluations in prostate cancer: Secondary analysis of NRG/RTOG 0415.

The Expanded Prostate Cancer Index Composite (EPIC) is the most commonly used patient reported outcome (PRO) tool in prostate cancer (PC) clinical trials, but health utilities associated with the different health states assessed with this tool are unknown, limiting our ability to perform cost-utility analyses. This study aimed to map EPIC tool to EuroQoL-5D-3L (EQ5D) to generate EQ5D health utilities. This is a secondary analysis of a prospective, randomized non-inferiority clinical trial, conducted between 04/2006 and 12/2009 at cancer centers across the United States, Canada, and Switzerland. Eligible patients included men >18 years with a known diagnosis of low-risk PC. Patient HRQoL data were collected using EPIC and health utilities were obtained using EQ5D. Data were divided into an estimation sample (n = 765, 70%) and a validation sample (n = 327, 30%). The mapping algorithms that capture the relationship between the instruments were estimated using ordinary least squares (OLS), Tobit, and two-part models. Five-fold cross-validation (in-sample) was used to compare the predictive performance of the estimated models. Final models were selected based on root mean square error (RMSE). A total of 565 patients in the estimation sample had complete information on both EPIC and EQ5D questionnaires at baseline. Mean observed EQ5D utility was 0.90±0.13 (range: 0.28-1) with 55% of patients in full health. OLS models outperformed their counterpart Tobit and two-part models for all pre-determined model specifications. The best model fit was: "EQ5D utility = 0.248541 + 0.000748*(Urinary Function) + 0.001134*(Urinary Bother) + 0.000968*(Hormonal Function) + 0.004404*(Hormonal Bother)- 0.376487*(Zubrod) + 0.003562*(Urinary Function*Zubrod)"; RMSE was 0.10462. This is the first study to identify a comprehensive set of mapping algorithms to generate EQ5D utilities from EPIC domain/ sub-domain scores. The study results will help estimate quality-adjusted life-years in PC economic evaluations.

Longitudinal predictive ability of mapping algorithms: Secondary analysis of NRG Oncology/RTOG 0415.

60 Background: Mapping algorithms informing economic evaluations are often derived using baseline data from clinical trials. It is unclear if these algorithms can predict health utilities accurately in post-intervention data. Thus, this study examines the longitudinal predictive ability of mapping algorithms derived from baseline trial data and explores the factors associated with prediction errors. Methods: This methodological study utilized data from an international, multicenter, randomized controlled trial of patients with low-risk prostate cancer (PC), conducted by NRG Oncology (NCT00331773). In addition to patient demographic and clinical data, this study utilized PRO data collected at baseline and 6, 12 and 24 months post-intervention. The Expanded Prostate Cancer Index Composite (EPIC) questionnaire measures health-related quality-of-life (HRQoL) and has four domains (urinary, sexual, hormonal, and bowel) and two subdomains per domain (function and bother); EuroQOL-5D-3L (EQ5D) captures health utilities. Ordinary Least Squares (OLS) regression models were used to map EPIC scores to EQ5D utilities in the baseline data through 5-fold cross-validation. Predictive performance was tested in the post-intervention data; predicted and reported utilities were compared using t-tests, and the absolute prediction error was modeled using fixed effects, as a function of baseline demographic and clinical covariates, as well as observed and predicted EQ5D utilities. Results: A total of 267 (199) patients had complete EQ5D and EPIC domain (or subdomain) data at baseline and all subsequent assessments. In the EPIC domain sample, mean ± standard deviation observed EQ5D utility was 0.90±0.13 at baseline, 0.92±0.11 at 6 months, 0.90±0.13 at 12 months and 0.89±0.14 at 24 months. Mean absolute differences (MDs) between reported and predicted were lower for models using EPIC subdomain data compared to EPIC domain data, and generally decreased as the time of assessment increased. The mapping functions over-predicted utilities for patients in perfect health while the prediction errors were increasingly negative for lower reported EQ5D scores. According to the fixed effects model for EPIC domain data, lower observed and predicted baseline EQ5D scores, and time of assessment were significant predictors of the absolute prediction error; for EPIC subdomain data, lower observed and predicted baseline EQ5D scores, hormonal bother and function, and bowel function significantly predicted the absolute prediction error. Conclusions: This study is the first to demonstrate the longitudinal validity of EPIC questionnaire, and builds upon existing research on longitudinal validity of mapping functions. The low MDs in prediction errors in post-intervention data indicate that the mapping functions are sensitive to treatment effect, thereby increasing confidence in their use in economic evaluations in PC.

A Pilot Study Assessing Aspects of Sexual Function Predicted to Be Important After Treatment for Prostate Cancer in Gay Men: An Underserved Domain Highlighted.

Purpose: Existing questionnaires assessing sexual function after prostate cancer (PCa) were developed in predominantly heterosexual male cohorts and may measure function incompletely in gay men. We sought to determine if there are sexual function domains relevant to gay men that are not captured by the Expanded Prostate Cancer Index Composite (EPIC) sexual function assessment. Methods: Fifty-three gay men with PCa responded to an online survey regarding the applicability of the sexual function domain in the validated EPIC questionnaire. They were then queried about whether the prostate is a source of sexual pleasure and the importance of measuring sexual satisfaction as it relates to receptive anal intercourse. Results: A majority of gay men with PCa found the EPIC sexual function tool to be applicable when measuring erectile function (76.5%). Of the men queried, 64.2% felt that the prostate is a source of sexual pleasure and 52.8% felt it important to measure sexual satisfaction associated with receptive anal intercourse. A larger proportion of gay men who engaged in receptive anal intercourse, compared with those who did not engage in receptive anal intercourse, felt that the prostate is a source of sexual pleasure (100% vs. 57.1%), and thought it important to measure sexual satisfaction as it relates to receptive anal intercourse after PCa treatment (90.0% vs. 45.2%). Conclusions: Our findings highlight the need to create a validated questionnaire to measure sexual satisfaction from receptive anal intercourse to help care for men engaging in receptive anal intercourse after PCa treatment.

Self-Reported Burden in Elderly Patients With Localized Prostate Cancer Treated With Stereotactic Body Radiation Therapy (SBRT).

Purpose: Retaining quality of life in patients treated with SBRT for prostate cancer remains paramount. As such, balancing the benefits of treatment against the effects of therapy on elderly patients is essential. The EORTC QLQ-ELD14 (ELD-14) is a validated questionnaire with a domain dedicated to burden of illness and treatment in the elderly. The Expanded Prostate Cancer Index Composite (EPIC)-26 is a validated questionnaire which measures urinary, bowel, sexual, and hormonal symptoms. This study reports trends in self-reported burden in patients with prostate cancer treated with SBRT and reveals convergence of self-reported burden with treatment related side effects obtained from the EPIC-26 questionnaire.Methods: All patients ≥70 years old, with localized prostate cancer treated with SBRT ± ADT at Medstar Georgetown University Hospital from 2013 to 2018 and had completed the ELD-14 were eligible for inclusion in this cross-sectional cohort study. Percentage of responses to questions related to disease and treatment burden were counted for each category (“not at all” and “a little” vs. “quite a bit” and “very much”). Additional demographic features were derived from available medical records. A total of 111 patients (median age of 74) responded to the ELD-14 questionnaire at onset of treatment and at the 2-year mark. Responses to EPIC questionnaires at matched follow-ups were scored and correlated with the self-reported burden domain of the ELD-14 using the Spearman correlation coefficient.Results: Number of patients reporting “quite a bit” or “very much” burden from prostate cancer was 6.3% prior to treatment. This was highest at 1-month (10.8%) and decreased to 9.0% at 24 months post-SBRT (X2 = 3.836, p = 0.6986). By comparison, 3.6 and 5.4% reported “quite a bit” or “very much” burden from treatment at start of treatment and 24 months, respectively (X2 = 1.046, p = 0.9838). Patient reported treatment burden was found to converge well with individual domains of EPIC-26. Patients undergoing ADT experienced more burden than their non-ADT counterparts.Conclusions: This cross-sectional study suggests a minority of patients reported high burden from their clinically localized prostate cancer or from their SBRT treatment. Self-reported burden converged well with lower EPIC scores in multiple domains.

Intensity-modulated radiotherapy of prostate cancer with simultaneous integrated boost after molecular imaging with 18F-choline-PET/CT : Clinical results and quality of life.

To analyze clinical results and quality of life of patients with localized prostate cancer after irradiation of the prostate with an18F-choline-PET/CT-based simultaneous integrated boost (SIB) in comparison to acontrol group without SIB. A total of 134 patients underwent intensity-modulated radiotherapy from 2007-2010. All patients received atotal dose of 76 Gy with 2 Gy fractions to the prostate; 67patients received an additional SIB of 80 Gy. The median follow-up was 65months. Quality of life was evaluated with the EPIC (Expanded Prostate Cancer Index Composite) questionnaire. Baseline characteristics were similar in both groups (prostate-specific antigen 11 ng/ml vs. 8 ng/ml, p = 0.20, Gleason score <6 in 36% vs. 46%, p = 0.22, with vs. without SIB). No prostate cancer-related death was observed. No significant difference of quality of life scores was found. The largest difference after 5-6years in comparison to baseline was reported for sexual bother (mean15 vs. 17points with vs. without SIB). Mean urinary scores did not decrease. Bowel bother scores changes were larger in the SIB group (mean5 vs. 2points, dependent on SIB volume), with increased bowel problems (15vs. 2% big/moderate problem with bowel movements, p = 0.03). However, atrend towards higher efficacy with SIB resulted (biochemical recurrence-free survival of 92% vs. 85%, p = 0.17). The first long-term analysis of patients treated with SIB based on molecular imaging with 18-F-choline-PET/CT showed an excellent biochemical recurrence-free survival, but alarger percentage of bowel problems in comparison to the control group.

Cultural adaptation and validation of the Chinese version of the expanded prostate cancer index composite.

The expanded prostate cancer index composite (EPIC) is a widely adopted instrument for the quality of life of patients with prostate cancer. We aimed to create a Chinese version of EPIC to further research in the Chinese-speaking population. A prototype was created by forward-backward translations and revisions. During cultural adaptation, 15 participants were interviewed after they had completed the prototype. A few issues highlighted included confusion related to the question format, subject non-familiarity with the Chinese term for "hot flashes," and the use of the Chinese term for "breast" as a strictly female body part. A pilot version was created based on the cultural adaptation findings. Validation of the pilot version was performed by having 50 participants complete the Chinese EPIC and EORTC QLQ-c30 twice within a 4-week period. Test-retest reliability (Pearson's correlations and difference distribution) and internal consistency (Cronbach's α) were measured using SAS version 9.4. Test-retest reliability values for the urinary, bowel, sexual and hormone domains were 0.71, 0.51, 0.51 and 0.66, respectively; subscale test-retest reliability ranged between 0.29 and 0.82. Internal consistency for domains was good with Cronbach's α ranging from 0.76 to 0.78 for the initial test and 0.67 to 0.85 for the retest. The performance of this version of EPIC was comparable to the validated EORTC QLQ-C30. The EPIC questionnaire was successfully translated into Chinese and was culturally adapted. The resultant Chinese version has high reliability and validity and will be an important tool for research on quality of life in the Chinese population.

Quality of life after brachytherapy or bilateral nerve-sparing robot-assisted radical prostatectomy for prostate cancer: a prospective cohort.

To provide comparative data on quality of life (QoL) after prostate cancer treatment to help patients make an informed decision regarding their choice of treatment. Patients with pathologically proven, non-metastatic, T1-T3bN0 prostate cancer were included in this prospective non-randomized study if they were to receive treatment with curative intent. Sample size was at least 181 patients per cohort/treatment type. QoL was recorded at baseline and at each follow-up using the Expanded Prostate Cancer Index Composite (EPIC) instrument. The minimal clinically important difference was defined as half of the standard deviation of the baseline score for each domain. A mixed effects model was used to compare the different treatments. Data are presented on the brachytherapy and the bilateral nerve-sparing robot-assisted radical prostatectomy (RARP) cohorts. Hormonotherapy was not allowed. Between November 2007 and January 2013, 181 patients who received brachytherapy and 210 patients who underwent RARP were included. Of the patients who underwent RARP, 178 had bilateral nerve-sparing and were included in the present analysis. Response rate to EPIC questionnaires were higher in the brachytherapy than in the RARP arm: 82% vs 57% at 2years after treatment and 55% vs 45% at 4years after treatment. In the mixed effects model, patients in the RARP arm had better QoL with regard to urinary irritation/obstruction or bother and bowel function, and lower QoL regarding sexual function and urinary incontinence. Results were confirmed in a propensity score-matched model. Patient satisfaction was significantly higher in the brachytherapy group at 1, 2 and 3years after treatment. This prospective non-randomized study shows long-term differences in QoL domains after bilateral nerve-sparing RARP and brachytherapy. Differences in patient satisfaction should be further explored. These results could be used to counsel patients in the decision-making process.

Preoperative sexual status of Japanese localized prostate cancer patients: comparison of sexual activity and EPIC scores

Objective: This study aimed to evaluate the relationship between sexual activity and sexual function using questionnaires distributed to middle-aged Japanese patients with localized prostate cancer.Methods: A total of 145 patients who underwent radical prostatectomy were enrolled in the survey reported on herein. Sexual activity and sexual function were investigated via the Expanded Prostate Cancer Index Composite (EPIC) and an original self-reported questionnaire.Results: Of participants, 24.1% and 20.7% had sexual activity within a month period as investigated via the EPIC and original questionnaire, respectively. However, 29.7% of all those who reported sexual activity rate reported “about once every 2 months to a year,” as shown in the original questionnaire. Regarding sexual function as addressed through EPIC, no results within that questionnaire’s measure of sexual function showed significant differences among patients with a rate of actual sexual activity.Conclusions: The present survey showed that more than quarter of preoperative middle-aged Japanese prostate cancer patients surveyed had actual sexual activity, though not within the preceding 4 weeks. To precisely evaluate sexual function of middle-aged Japanese patients, it is necessary to consider actual sexual activity.

Cross-cultural adaptation and validation of the French version of the Expanded Prostate cancer Index Composite questionnaire for health-related quality of life in prostate cancer patients.

BackgroundHealth-related quality of life (HRQoL) has been positioned as one of the major endpoints in oncology. Thus, there is a need to validate cancer-site specific survey instruments. This study aimed to perform a transcultural adaptation of the 50-item Expanded Prostate cancer Index Composite (EPIC) questionnaire for HRQoL in prostate cancer patients and to validate the psychometric properties of the French-language version.MethodsThe EPIC questionnaire measures urinary, bowel, sexual and hormonal domains. The first step, corresponding to transcultural adaptation of the original English version of the EPIC was performed according to the back translation technique. The second step, comprising the validation of the psychometric properties of the EPIC questionnaire, was performed in patients under treatment for localized prostate cancer (treatment group) and in patients cured of prostate cancer (cured group). The EORTC QLQ-C30 and QLQ-PR25 prostate cancer module were also completed by patients to assess criterion validity. Two assessments were performed, i.e., before and at the end of treatment for the Treatment group, to assess sensitivity to change; and at 2 weeks’ interval in the Cured group to assess test-retest reliability. Psychometric properties were explored according to classical test theory.ResultsThe first step showed overall good acceptability and understanding of the questionnaire. In the second step, 215 patients were included from January 2012 to June 2014: 125 in the Treatment group, and 90 in the Cured group. All domains exhibited good internal consistency, except the bowel domain (Cronbach’s α = 0.61). No floor effect was observed. Test-retest reliability assessed in the cured group was acceptable, expect for bowel function (intraclass coefficient = 0.68). Criterion validity was good for each domain and subscale. Construct validity was not demonstrated for the hormonal and bowel domains. Sensitivity to change was exhibited for 5/8 subscales and 2/4 summary scores for patients who experienced toxicities during treatment.ConclusionsThe French EPIC questionnaire seems to have adequate psychometric properties, comparable to those exhibited by the original English-language version, except for the construct validity, which was not available in original version.

Long-Term Quality of Life in Prostate Cancer Patients Treated with Cesium-131

Prostate brachytherapy (PB) as monotherapy or in combination with external beam radiotherapy (EBRT) represents a curative treatment option for men with prostate cancer. Several radioactive isotopes are approved for use in prostate brachytherapy. Among these, Cesium-131 is the newest to market and has the shortest half-life, a property which gives it dosimetric advantages. Little data exists as to the long-term quality of life (QoL) in patients treated with Cs-131. We identified the first 272 patients treated at our institution with Cs-131, all of whom were treated greater than 5 years ago. Patients were treated between September 2006 and October 2010. These patients were asked to fill out an Expanded Prostate Cancer Index Composite (EPIC) QoL questionnaire and American Urological Association Symptom Score (AUASS) survey before treatment and at each of their follow-up appointments. EPIC scores were reported on a normalized scale from 0-100 (with higher score representing better QoL) for the following categories: Urinary Summary (US), Urinary Function (UF), Urinary Bother (UB), Urinary Incontinence (UI), Urinary Irritation/Obstruction (UIO), Bowel Summary (BS), Bowel Function (BF), and Bowel Bother (BB). AUA scores were reported on a scale of 0-35 (with higher scores representing worse symptomatology). We compared patients’ EPIC and AUA scores at baseline to those at 5-yrs post-treatment. Mean scores were compared using a paired-samples t-test. Clinically significant improvement or worsening in QoL was defined as a change of 10 or more points in EPIC score or 3 or more in AUA score. At 5-yrs of follow-up, 129 patients (47%) had completed both EPIC and AUA questionnaires and one additional patient completed AUA only. Of these 130 patients, median age was 65 (Interquartile range =61-71), 28% had EBRT prior to PB, risk groups were: 40% low-risk; 51% intermediate-risk; 9% high-risk, and 18% received hormonal therapy. Baseline mean EPIC scores were as follows: US=86.7, UF=93.5, UB=82.0, UI=90.8, UIO=85.9, BS=91.5, BF=92.2, BB=90.8. Baseline mean AUA score was 6.9. Average changes in scores at 5-yrs were as follows: US=0.30 (p=0.78), UF=-1.33 (p=0.20), UB=1.51 (p=0.28), UI=-3.25 (p=0.02), UIO=1.98 (p=0.08), BS=-0.07 (p=0.94), BF=-0.26 (p=0.77), BB=-0.11 (p=0.93), AUA=0.18 (p=0.72). The percent of patients with a clinically significant worsening of symptomatology were: US=18%, UF=19%, UB=22%, UI=24%, UIO=14%, BS=13%, BF=16%, BB=17%, AUA=30%. The percent of patients with a clinically significant improvement of symptomatology were: US=15%, UF=14%, UB=27%, UI=15%, UIO=21%, BS=16%, BF=15%, BB=19%, AUA=26%. Our results demonstrate minimal long-term urinary or bowel toxicity with Cs-131 prostate brachytherapy. There were no significant long-term differences in EPIC Urinary Summary score, EPIC Bowel Summary score, or AUA symptom score. As population-based means tend to underestimate individual effects, our conclusion is further validated by the small absolute difference in the rates of clinical improvement and worsening (<10% for all variables).

Comparison of Health Related Quality of Life and Other Clinical Parameters between 20 g and 18 g Needles for Permanent Low-Dose-Rate Implantation in Localized Prostate Cancer

Introduction/objective: To evaluate short-term, treatment-specific endpoints observed following transperineal permanent prostate brachytherapy (TPPB) in patients with low and intermediate risk prostate cancer using a 20- gauge (g) needle technique as compared to traditional 18g needle technique. Our goal was to assess the impact of treatment on urinary, bowel, sexual function and bother as measured by Expanded Prostate Cancer Index Composite (EPIC) quality of life instrument prior to treatment and at 1,3,6 months after treatment. Additionally, acute urinary retention as measured by catheter use following prostate brachytherapy was investigated. Methods and materials: This study was a single institution, balanced, randomized, non-blinded, dual arm interventional study. We accrued 242 low to intermediate risk patients between June 2010 and August 2012. There were 111 patients randomized to 18 g needles (Arm 1) and 131 patients randomized to 20g needles (Arm 2). A matched peripheral dose of 145 Gy was prescribed in all cases. Patients completed EPIC questionnaires prior to TPPB and at 1, 3 and 6 months post treatment. Results: Upon analysis of EPIC scores at each time point post implantation, there was no significant difference between the two arms at any given time period specific to the urinary, bowel and sexual function and bother domains. However, 6/111 (5.4%) patients in Arm 1 and 0/131 (0%) patients in Arm 2 required Foley catheterization secondary to AUR, demonstrating a significant difference (p=0.007). Less than 2cc of perineal bleeding was seen in all patients, with no perineal pain or bruising reported. Conclusion: These data demonstrate that there was no statistically significant difference regarding quality of life parameters between Arm 1 and Arm 2. There was, however, a statistically significant outcome for AUR favoring the 20 g cohort that had 0% AUR.

438 CAN WE PREDICT WHICH PATIENTS URINARY SYMPTOMS IMPROVE FOLLOWING A ROBOTIC PROSTATECTOMY? RESULTS OF EXPANDED PROSTATE CANCER INDEX COMPOSITE (EPIC) URINARY QUALITY OF LIFE OUTCOMES FOLLOWING ROBOTIC PROSTATECTOMY IN A COMMUNITY BASED HEALTHCARE SYSTEM

INTRODUCTION AND OBJECTIVES: Herein we describe various preoperative, operative and pathological variables associated with an improvement in EPIC urinary symptom scores following a robotic prostatectomy. METHODS: From October 2003 to June 2009 Expanded Prostate cancer Index Composite (EPIC) scores and demographic information were prospectively obtained from 623 patients who underwent a robotic radical prostatectomy. Patients received EPIC questionnaires preoperatively 6, 12, 24, 36, 48 and 60 months post-surgery. Two binary outcome variables were created: improvement in urinary incontinence and improvement in urinary bother. Improvement is defined by comparing the value at each post-operative time point to the subject’s baseline value on that subscale, and coding the subject as “improved” if his value at that time point was at least .5 standard deviations greater than his baseline value; otherwise he was considered as “not improved”. This longitudinal data was analyzed with the use of generalized estimating equations (GEE) models that relate the proportion of patients with improvement since procedure to various variables. RESULTS: The highest proportions reporting improvement was 14% at 5 years post-procedure for urinary incontinence and 37.8% at 4 years for urinary bother. The final model with proportion showing improvement in urinary incontinence score included recovery time, African-American race, employment status, nerve-sparing, and prostate weight. Recovery time (P 0.01), African-American race (P 0.01, OR 0.375), and increased prostate weight (P 0.01;OR 2.677) were significantly associated with improvement in urinary incontinence score. The final model with the outcome of proportion showing improvement in urinary bother score included recovery time, body mass index (BMI) category, smoking status, employment category, presence of hypertension, nerve-sparing, and prostate weight. However only recovery time, (p 0.0001), BMI, (P 0.03), (OR 1.108 for overweight compared to low-normal and 0.695 for obese compared to low-normal), and prostate weight had a significant positive association (P 0.0049, estimated odds ratio 1.891). CONCLUSIONS: Various demographic variables are associated with improved urinary quality of life measures. These factors may better identify ideal surgical candidates for a robotic prostatectomy.

Incidence and Predictors of Acute and Chronic Rectal Bleeding as Reported by Patients Through EPIC Questionnaire for Prostate Brachytherapy Using Cesium

To report the incidence of acute and chronic rectal bleeding, based on the patient reported Expanded Prostate Cancer Index Composite (EPIC) score, and to investigate factors predictive of rectal bleeding in patients who underwent prostate brachytherapy (PB) with Cesium-131 (131Cs).

IGF-1 levels are significantly correlated with patient-reported measures of sexual function

Growth hormone (GH) supplementation may help to preserve erectile function. We assessed whether serum insulin-like growth factor 1 (IGF-1) levels, a surrogate for GH levels, correlate with sexual function scores in 65 men who completed the Sexual Health Inventory for Men (SHIM) and Expanded Prostate Cancer Index Composite (EPIC) questionnaires, and had serum IGF-1 and testosterone levels determined. Median±s.d. IGF-1 level, SHIM and EPIC scores were 235.0±86.4, 19.5±8.7 and 56.4±28.3 mg ml(-1), respectively. IGF-1 levels and total SHIM score correlate significantly (r=0.31, P=0.02), as do IGF-1 levels and all individual SHIM question scores, and IGF-1 levels and the sexual domain of the EPIC questionnaire (r=0.30, P=0.02). No correlation was observed between IGF-1 levels and Gleason score, IGF-1 and testosterone level or SHIM score and testosterone level. These data support a potential role for the GH axis in erectile function.

High-Dose-Rate Brachytherapy as a Monotherapy for Favorable-Risk Prostate Cancer: A Phase II Trial

There are multiple treatment options for favorable-risk prostate cancer. High-dose-rate (HDR) brachytherapy as a monotherapy is appealing, but its use is still investigational. A Phase II trial was undertaken to explore the value of such treatment in low-to-intermediate risk prostate cancer. This was a single-institution, prospective study. Eligible patients had low-risk prostate cancer features but also Gleason scores of 7 (51% of patients) and stage T2b to T2c cancer. Treatment with HDR brachytherapy with a single implant was administered over 2 days. One of four fractionation schedules was used in a dose escalation study design: 3 fractions of 10, 10.5, 11, or 11.5 Gy. Patients were assessed with the Common Terminology Criteria for Adverse Events version 2.0 for urinary toxicity, the Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer scoring schema for rectal toxicity, and the Expanded Prostate Cancer Index Composite (EPIC) questionnaire to measure patient-reported health-related quality of life. Biochemical failure was defined as a prostate-specific antigen (PSA) nadir plus 2 ng/ml. Between 2003 and 2008, 79 patients were enrolled. With a median follow-up of 39.5 months, biochemical relapse occurred in 7 patients. Three- and 5-year actuarial biochemical control rates were 88.4% (95% confidence interval [CI], 78.0-96.2%) and 85.1% (95% CI, 72.5-94.5%), respectively. Acute grade 3 urinary toxicity was seen in only 1 patient. There was no instance of acute grade 3 rectal toxicity. Rates of late grade 3 rectal toxicity, dysuria, hematuria, urinary retention, and urinary incontinence were 0%, 10.3%, 1.3%, 9.0%, and 0%, respectively. No grade 4 or greater toxicity was recorded. Among the four (urinary, bowel, sexual, and hormonal) domains assessed with the EPIC questionnaire, only the sexual domain did not recover with time. HDR brachytherapy as a monotherapy for favorable-risk prostate cancer, administered using a single implant over 2 days, is feasible and has acceptable acute and late toxicities. Further follow-up is still required to better evaluate the efficacy of such treatment.