Expanded Prostate Cancer Index Composite Research Articles

Analysis of Gastrointestinal Toxicity in Patients Receiving Proton Beam Therapy for Prostate Cancer: A Single-Institution Experience

PurposeWe characterized both physician- and patient-reported rates of gastrointestinal (GI) toxicity in patients treated with proton beam therapy (PBT) at our institution for prostate adenocarcinoma and identified factors associated with toxicity. Methods and materialsWe treated 192 patients with PBT between July 2013 and July 2016. Included patients had ≥1 year of follow-up. Potential preexisting clinical and treatment-related risk factors for GI toxicity were recorded. Common Terminology Criteria for Adverse Events version 4.0 was used to score toxicity. Expanded Prostate Cancer Index Composite (EPIC) bowel domain questionnaires assessed patient-reported quality of life. Associations between grade (GR) 2+ toxicity and clinical, treatment, and dosimetric factors were assessed using Cox models and corresponding hazard ratios. ResultsThe median follow-up was 1.7 years. Most of the observed GI toxicity (>90%) was in the form of rectal bleeding (RB). GR2+ GI toxicity and RB actuarial rates specifically at 2 years were 21.3% and 20.4%, respectively. GR3 toxicity was rare, with only 1 observed RB event. No GR4/5 toxicity was seen. The EPIC bowel domain median score was 96 (range, 61-100) pretreatment, 93 (range, 41-100) at 1 year, 89 (range, 57-100) at 1.5 years, and 89 (range, 50-100) at 2 years. Anticoagulation use was the only factor selected during multivariate analysis for predicting GR2+ RB, with a resulting concordance index of 0.59 (95% confidence interval, 0.48-0.68; P = .088). Type of proton technology (pencil beam scanning vs uniform scanning) and number of fields treated per day (1 vs 2) showed no significant difference in toxicity rate. ConclusionsPBT was associated with acceptable rates of GR2+ transient GI toxicity, mostly in the form of RB, which correlated with anticoagulation use. High EPIC bowel domain quality of life was maintained in the 2 years after treatment.

Patient and Dosimetric Predictors of Genitourinary and Bowel Quality of Life After Prostate SBRT: Secondary Analysis of a Multi-institutional Trial

Stereotactic body radiation therapy (SBRT) is an emerging option for localized prostate cancer. However, there are no standard dosimetric guidelines, and normal tissue tolerances for extreme hypofractionation are not well defined. We analyzed dosimetric correlations with patient-reported urinary and bowel quality of life (QOL) on a prospective trial. Patients with low- or intermediate-risk prostate cancer from 18 institutions were enrolled on a phase 2 trial from 2007 to 2012 and treated using robotic SBRT to 38Gy in 4 fractions on consecutive days. No androgen deprivation was used. Patients received simulation with Foley catheter for urethral delineation. The clinical target volume was prostate (low-risk patients) or prostate plus 1cm of proximal seminal vesicles (intermediate-risk patients). Multiple dosimetric measures for urethra, bladder, and rectum were prospectively recorded. QOL using the Expanded Prostate Cancer Index Composite was assessed before and after treatment at protocol-specific time points. Linear regression was used to assess factors associated with QOL at 1month and 2years. A total of 259 patients were enrolled. QOL data were available for 98%, 96%, and 84% at baseline, 1month, and 2years, respectively. Median age was 69years. Prior transurethral resection of the prostate and clinical target volume size were associated with 2-year urinary incontinence. There was a trend toward worse 2-year obstruction/irritation in older patients on multivariable analysis. Bladder and urethral doses were not associated with either 1-month or 2-year urinary QOL. In contrast, rectum maximum dose was associated with both 1-month and 2-year bowel QOL. At 2years, the proportion with moderate or big overall bowel problems (as defined by Expanded Prostate Cancer Index Composite-26) was significantly higher in patients with rectum maximum dose greater than versus less than the median 37.4Gy (11% vs 2%, Fisher's exact test P=.008). These results provide novel data that contribute to a better understanding of patient and dosimetric factors associated with adverse QOL effects from prostate SBRT.

A Prospective Analysis of the Effects of Nerve-Sparing Radical Prostatectomy on Urinary Continence Based on Expanded Prostate Cancer Index Composite and International Index of Erectile Function Scoring Systems.

PurposeThis study aims to objectively characterize the effect of successful nerve sparing (NS) during radical prostatectomy (RP) on postoperative urinary continence (UC) using International Index of Erectile Function (IIEF)-scores and a previously described Expanded Prostate Cancer Index Composite (EPIC) score cutoff value (COV) for UC. Several notable studies on this topic present conflicting outcomes. This is largely due to a lack of clear definitions and consensus regarding preserved erectile function (EF) and UC.MethodsThis study is comprised of all patients who underwent RP at the Kantonsspital Baden, Switzerland, between 2004 and 2013. Patients completed self-assessment questionnaires for UC (EPIC) and EF (IIEF) pre- and postoperatively (3, 6, 9, 12, 18, and 24 months; yearly thereafter). We used a previously described EPIC subscore COV, with “satisfactory continence” signified by a score >85. Statistical analysis was performed using Kaplan-Meier and Cox regression analyses for “surgeon-” and “IIEF-defined” NS definitions.ResultsOf 236 men with a median age of 63 years (interquartile range [IQR], 59–66 years) and median follow-up time of 48 months (IQR, 30–78 months), 176 underwent unilateral (n=33) or bilateral (n=143) NS RP. Fifty-four underwent non-NS (NNS) RP. Kaplan-Meier analyses identified the following risk factors for UC: age, prostate volume, cancer risk group, and NS status. In surgeon-defined NS RP cases, multivariate analysis for regaining continence demonstrated no significant difference (hazard ratio [HR], 0.78; 95% confidence interval [CI], 0.48–1.25; P=0.3). With successful IIEF-defined NS RPs, regression analysis demonstrated no significant difference (HR, 0.89; 95% CI, 0.59–1.35; P=0.58).ConclusionsIn our population, analysis and comparison of surgeon- and IIEF-defined NS and NNS cohorts revealed that NS RP did not improve postoperative UC. The conservation of UC alone should not motivate surgeons or patients to pursue NS RP.

Patient Reported Outcome Measures for Transperineal Template Prostate Mapping Biopsies in the PICTURE Study

Transperineal template prostate mapping biopsy is an increasingly used method of procuring tissue from men with suspected prostate cancer. We report patient related outcome measures and adverse events in men in the PICTURE trial (ClinicalTrials.gov NCT01492270) who underwent this diagnostic test. A total of 249 men underwent multiparametric magnetic resonance imaging followed by transperineal template prostate mapping biopsy as a validation study. Functional outcomes before and after transperineal template prostate mapping were prospectively collected and recorded with questionnaires, including the I-PSS (International Prostate Symptom Score), the I-PSS-QoL (Quality of Life), the IIEF-15 (International Index of Erectile Function-15) and the EPIC (Expanded Prostate Cancer Index Composite) urinary function. Mean age was 62 years, median prostate specific antigen was 6.8 ng/ml and median gland size was 37 ml. At transperineal template prostate mapping biopsy a median of 49 cores (IQR 40-55) were taken. Mean time to complete the post-procedure patient related outcome measure questionnaires was 46 days. Adverse events included post-procedure acute urinary retention in 24% of patients, rectal pain in 26% and perineal pain in 41%. Transperineal template prostate mapping biopsy resulted in a statistically significant increase in scores on the I-PSS from 10.9 to 11.8 (p = 0.024) and the I-PSS-QoL from 1.57 to 1.76 (p= 0.03). The IIEF-15 erectile function score decreased by 23.2% from 47.7 to 38.7 (p <0.001). Significant deterioration was noted in all 5 of IIEF-15 functional domains, including erectile and orgasmic function, sexual desire, and intercourse and overall satisfaction (p <0.001). EPIC urinary scores showed no overall change from baseline. Transperineal template prostate mapping biopsy causes a high urinary retention rate and a detrimental impact on genitourinary functional outcomes, including deterioration in urinary flow and sexual function. Our findings can be used to ensure adequate counseling about transperineal template prostate mapping biopsies. The results point to a need for strategies such as multiparametric magnetic resonance imaging and targeted biopsies to minimize the harms of transperineal template prostate mapping biopsy.

Does partnership status affect the quality of life of men having robotic-assisted radical prostatectomy (RARP) for localised prostate cancer?

ObjectiveTo investigate whether there are any differences in prostate cancer-specific QoL measures at baseline and at 12-months post-surgery between partnered and unpartnered men having robot-assisted radical prostatectomy (RARP) for localised prostate cancer. MethodsWe investigated differences in patient-reported outcomes using the Expanded Prostate cancer Index Composite-26 (EPIC-26) and the Clark et al. Prostate Cancer Quality of Life Scales. ResultsFive hundred and forty patients were eligible for this study, 56 of whom were unpartnered. We found few differences between partnered and unpartnered men in terms of patient-reported quality of life outcomes following RARP. In our sample of patients with a high socio-economic status, partnered men had lower 12-month postoperative EPIC sexual domain scores and clinical T-stage and were more likely to be sexually active preoperatively. Overall, our data show that men having RARP for prostate cancer have low sexual confidence, high PSA concern and a low outlook at 12-months post-RARP, irrespective of partnership status. ConclusionThe findings of this study suggest that the RARP patient could benefit from a healthcare system that assesses patient sexual outcome following prostatectomy beyond potency and ability to penetrate a partner. By remaining cognisant of other domains such as sexual intimacy, sexual confidence, masculine self-esteem, health worry, PSA concern, outlook and treatment regret, nursing staff may be able to benefit the prostatectomy patient. Where deficits in these domains are observed by the nurse, referral for specialist psychological review could be made. Whether this could work to improve sexual outcomes in men following RARP deserves further investigation.

(P20) Decreased PSA Nadir as a Result of Dose-Escalated Stereotactic Body Radiation for Patients With Low- and Intermediate-Risk Prostate Cancer

Prostate cancer (CaP) is characterized by a low a/b ratio relative to surrounding normal tissue, and consequently a therapeutic gain could be achieved with dose escalation. While potentially ablative PSA nadirs have been demonstrated following LDR brachytherapy, the ability to achieve ablation following stereotactic body radiation therapy (SBRT) remains unclear. The purpose of this study was to report the clinical outcomes, PSA kinetics, and toxicities in patients with low and intermediate-risk CaP treated on a prospective, Phase I/II, IRB approved dose-escalated SBRT trial. From 2011 to 2016, 26 patients with low and intermediate-risk CaP received 40, 45, and 50 Gy in five fractions to the prostate and seminal vesicles in cohorts of 9, 10, and 7 patients (pts). Self-reported QOL was prospectively measured from the Expanded Prostate Cancer Index Composite (EPIC) and International Prostate Symptom Score (IPSS) at baseline and intervals of every 3 months for the first two years followed by every 6 months thereafter. Common Toxicity Criteria for Adverse Events v. 4.03, data was collected to observe acute and late toxicities. No pts received androgen deprivation therapy. Median follow-up was 4.8 years. A PSA nadir <0.5 ng/ml was seen in 22%, 80%, and 71% of patients receiving 40, 45, and 50 Gy, and <0.2 ng/ml in 11%, 50%, and 71% of patients after 3 years. After 5 years, a PSA nadir <0.5 ng/ml was achieved in 100% of patients receiving 45 Gy compared to 33% receiving 40 Gy. PSA nadir was significantly reduced when comparing cohorts receiving 45 or 50 Gy to 40 Gy one to five years following treatment (p<0.02). PSA velocity was not significantly different among treatment groups, demonstrating a sharp initial decline followed by gradual reduction at -1.394, -0.706, -0.330, -0.160, -0.104, -0.070, and -0.050 ng/mL/month, after 3 months, 6 months, 1 year, 2 years, 3 years, 4 years, and 5 years. A benign PSA bounce was observed in 8 patients (32%) at a median bounce height of 0.72 ng/ml after 18 months, demonstrating a trend towards an increased bounce height with increasing fractional dose. There was an acute increase in EPIC and IPSS scores followed by a return to baseline over two years. Acute Grade 2 urinary toxicity occurred in 10 pts with no significant difference among treatment arms. The three patients experiencing late Grade 2 toxicity were in the 45 or 50 Gy cohort. There were no Grade 3 or higher toxicities. Univariate analysis revealed that Grade 2 toxicity was associated with prostate size >60 cc (p<.01). One biochemical failure was observed in the 40 Gy arm after 3.6 years resulting in a freedom from biochemical failure rate of 96% at 5 years. Prostate cancer specific survival was 100% and actuarial overall survival was 96%. This small prospective dose-escalation study identified that higher doses of 45 and 50 Gy, respectively are associated with improved PSA nadir without increased risk of GU or GI toxicity. Further follow-up is needed to assess PSA freedom from recurrence and late toxicity.

MP74-16 MEASURING SEXUAL FUNCTION AFTER TREATMENT FOR PROSTATE CANCER IN MEN WHO HAVE SEX WITH MEN: A HIDDEN DOMAIN EMERGES

You have accessJournal of UrologySexual Function/Dysfunction: Evaluation II1 Apr 2018MP74-16 MEASURING SEXUAL FUNCTION AFTER TREATMENT FOR PROSTATE CANCER IN MEN WHO HAVE SEX WITH MEN: A HIDDEN DOMAIN EMERGES Channa Amarasekera, Vincent Wong, James Burns, Kyle Tsai, David Victorson, and Shilajit Kundu Channa AmarasekeraChanna Amarasekera More articles by this author , Vincent WongVincent Wong More articles by this author , James BurnsJames Burns More articles by this author , Kyle TsaiKyle Tsai More articles by this author , David VictorsonDavid Victorson More articles by this author , and Shilajit KunduShilajit Kundu More articles by this author View All Author Informationhttps://doi.org/10.1016/j.juro.2018.02.2400AboutPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissionsReprints ShareFacebookTwitterLinked InEmail INTRODUCTION AND OBJECTIVES Treatment for prostate cancer (PCa) can lead to significant impairments in sexual function (SF). Assessing SF both pre- and post-treatment provides an assessment of baseline function and helps measure progress with recovery. Several validated questionnaires exist for measuring SF. However, these instruments were validated using cohorts of men that were predominantly heterosexual. Men who have sex with men (MSM) have different sexual repertoires compared to heterosexual men (HSM) and current instruments may not apply to this population. Our objective was to determine if there are SF domains relevant to MSM that are missed by existing tools. METHODS We administered an online self-reported questionnaire to a cohort of 618 men from across the US (285 MSM, 333 HSM) regarding the applicability of the sexual function domain in the validated Expanded Prostate Cancer Index Composite (EPIC) questionnaire. These men were then queried about areas of concern in SF that may have missed by this instrument. Continuous variables were analyzed with a t-test, and a chi-square test was utilized for categorical variables. RESULTS The two cohorts were well matched with regard to demographics, including age, race, and education. MSM and HSM found EPIC-SF equally applicable at measuring erectile function (72.61% of MSM and 73.34% of HSM, p=.74). With regard to currently unmeasured domains, a larger number of MSM felt that prostate stimulation was a source of sexual satisfaction for the receptive partner during receptive anal intercourse (RAI) compared to HSM (61.9% vs. 12.77%, p<.0001). A larger proportion of MSM also felt it important to measure sexual satisfaction with RAI when assessing sexual function after PCa treatment (50.0% MSM vs. 12.2% HSM, p=.0002). When stratifying for MSM who engaged in RAI in the preceding year (MSM-RAI) vs. MSM who did not, a larger proportion of MSM-RAI felt that prostate stimulation was a source of sexual satisfaction during RAI (87.5% vs. 66.3%, p=.001), and more MSM-RAI thought it important to measure sexual satisfaction as it relates to RAI after PCa treatment (75.3% vs. 53.94%, p<.001). CONCLUSIONS Currently used instruments measuring SF are applicable to MSM and HSM with regard to erectile function, but fail to measure sexual satisfaction as it relates to RAI, an important area of sexual function for MSM, particularly in MSM who engage in RAI. Our findings highlight the need to add a domain relating to sexual satisfaction from RAI, to help care for and follow sexual minorities treated for PCa. © 2018FiguresReferencesRelatedDetails Volume 199Issue 4SApril 2018Page: e1005-e1006 Advertisement Copyright & Permissions© 2018MetricsAuthor Information Channa Amarasekera More articles by this author Vincent Wong More articles by this author James Burns More articles by this author Kyle Tsai More articles by this author David Victorson More articles by this author Shilajit Kundu More articles by this author Expand All Advertisement Advertisement PDF downloadLoading ...

Pair-matched patient-reported quality of life and early oncological control following focal irreversible electroporation versus robot-assisted radical prostatectomy

PurposeThe design, conduct and completion of randomized trials for curative prostate cancer (PCa) treatments are challenging. To evaluate the effect of robot-assisted radical prostatectomy (RARP) versus focal irreversible electroporation (IRE) on patient-reported quality of life (QoL) and early oncological control using propensity-scored matching.MethodsPatients with T1c–cT2b significant PCa (high-volume ISUP 1 or any 2/3) who received unifocal IRE were pair-matched to patients who received nerve-sparing RARP. Patient-reported outcomes were prospectively assessed using the Expanded Prostate Cancer Index Composite (EPIC), AUA symptom score and Short Form of Health Survey (SF-12) physical and mental components. Oncological failure was defined as biochemical recurrence (RARP) or positive follow-up biopsies (IRE). Generalized mixed-effect models were used to compare IRE and RARP.Results50 IRE patients were matched to 50 RARP patients by propensity score. IRE was significantly superior to RARP in preserving pad-free continence (UC) and erections sufficient for intercourse (ESI). The absolute differences were 44, 21, 13, 14% for UC and 32, 46, 27, 22% for ESI at 1.5, 3, 6, and 12 months, respectively. The EPIC summary scores showed no statistically significant differences. Urinary symptoms were reduced for IRE and RARP patients at 12 months, although IRE patient initially had more complaints. IRE patients experienced more early oncological failure than RARP patients.ConclusionsThese data demonstrated the superior preservation of UC and ESI with IRE compared to RARP up to 12 months after treatment. Long-term oncological data are warranted to provide ultimate proof for or against focal therapy.

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.

The German version of the Expanded Prostate Cancer Index Composite (EPIC): translation, validation and minimal important difference estimation

BackgroundNo official German translation exists for the 50-item Expanded Prostate Cancer Index Composite (EPIC), and no minimal important difference (MID) has been established yet. The aim of the study was to translate and validate a German version of the EPIC with cultural adaptation to the different German speaking countries and to establish the MID.MethodsWe translated and culturally adapted the EPIC into German. For validation, we included a consecutive subsample of 92 patients with localized prostate cancer undergoing radical prostatectomy who participated the Prostate Cancer Outcomes Cohort. Baseline and follow-up assessments took place before and six weeks after prostatectomy in 2010 and 2011.We assessed the EPIC, EORTC QLQ-PR25, Feeling Thermometer, SF-36 and a global rating of health state change variable. We calculated the internal consistency, test-retest reliability, construct validity, responsiveness and MID.ResultsFor most EPIC domains and subscales, our a priori defined criteria for reliability were fulfilled (construct reliability: Cronbach’s alpha 0.7–0.9; test-retest reliability: intraclass-correlation coefficient ≥ 0.7). Cross-sectional and longitudinal correlations between EPIC and EORTC QLQ-PR25 domains ranged from 0.14–0.79, and 0.06–0.5 and 0.08–0.72 for Feeling Thermometer and SF-36, respectively. We established MID values of 10, 4, 12, and 6 for the urinary, bowel, sexual and hormonal domain.ConclusionThe German version of the EPIC is reliable, responsive and valid to measure HRQL in prostate cancer patients and is now available in German language. With the suggested MID we provide interpretation to what extent changes in HRQL are clinically relevant for patients. Hence, study results are of interest beyond German speaking countries.

Radical prostatectomy in metastatic castration-resistant prostate cancer: Feasibility, safety, and quality of life outcomes.

244 Background: Ongoing studies are evaluating the role of definitive treatment of the primary tumor in men with de novo metastatic prostate cancer. If proven beneficial, the optimal timing of the intervention will need to be considered. Little is known regarding the safety and quality of life outcomes of RP in metastatic castration resistant PCa (mCRPC). Methods: 14 pts undergoing RP on clinical trials and in the setting of mCRPC from 2008-2016 were analyzed. Intra-op and post-op complications were assigned Clavien-Dindo grade. Post-op expanded prostate cancer index composite (EPIC) urinary domains quality of life (QOL) outcomes were reviewed. Results: Patient characteristics were summarized (Table). 5 (36%) pts received platinum based chemo prior to RP. 4 pts had a decrease in PSA post RP (range: 0.2-57.3 ng/ml); 7 pts had an increase in PSA post RP (range: 0.1-24.5 ng/ml); and 3 pts’ PSA was unchanged. Positive surgical margin rate was 57%. 3 of 6 cN0 pts were pN1. 1 of 8 cN1 pts were pN0. 12/14 pts underwent extended lymphadenectomy with a median 3 (IQR 0-4) positive LNs out of 17 (IQR 11-25) LNs removed. Median op time was 239 min (IQR 186-304). Median EBL was 200cc (IQR 150-225). 8 pts had bilateral non-nerve sparing. Median pre-op and &lt;3month post-op EPIC urinary function QOL scores were 84 (IQR 70-95) and 78 (IQR 62-810) respectively. 30-day mortality was 0% and 12/14 pts were alive at 1 year post RP. There were no intra-op complications. There was one Clavien Grade III complication (pelvic abscess), with remaining 5 complications either Grade I or II. Conclusions: In this select cohort of pts with mCRPC, RP was feasible with limited complications. Differences in pre-op and post-op urinary QOL scores were not clinically significant. Given the retrospective nature of the review and the heterogeneity of this heavily pre-treated population, clinical benefit cannot be ascribed to the intervention. Thus, we caution against RP in mCRPC outside of well-designed clinical trials other than for palliation. [Table: see text]

The role of proton beam therapy for patients with intermediate- and high-risk prostate cancer.

97 Background: Although there are many patterns of treatment in localized prostate caner, proton beam therapy has no definite role in them. We aimed to assess the outcomes of proton beam therapy (PBT) alone for patients with intermediate- and high-risk prostate cancer, and to clarify the role of PBT in the treatments. Methods: Between Jan. 2011 and Sep. 2014, 204 patients with intermediate- and high-risk prostate cancer who declined to receive hormonal treatments until biochemical or clinical recurrence were enrolled in the study. All patients were irradiated a 70-78 GyE in 28-39 fractions, and pre-treatment risk groups were classified in accordance with the D’Amico criteria. The 5-year (biochemical or clinical) recurrence-free survival (RFS), late gastrointestinal (GI) and genitourinary (GU) toxicity (NCI-CTCAE ver.4.0) were evaluated. We conducted a survey on sexual quality of life (QOL) every six months to evaluate any long-term damage to the sexual function using the Expanded Prostate Cancer Index Composite (EPIC). Results: The mean age and the follow-up period were 66 (range: 39-86) and 52 months (range: 24-76 months), respectively. The 5-year RFS rates in intermediate- (n = 112) and high- (n = 92) risk groups were 96.9% and 83.4%, respectively. There was a significant difference between the two groups (p = 0.002). The incidence of grade 2+ GI and GU toxicity were 4% and 3%, respectively. We found a significant difference in the GI toxicity between the two radiation protocols of 78GyE/39fractions (n = 6, 11%) and 70GyE/28fractions (n = 0, 0%) (p &lt; 0.01). A 5.8% decrease in average after adjusting for aging was found in sexual summary score in six years after treatment, which was equivalent to aging of three years. Conclusions: Proton beam therapy alone demonstrated favorable results in patients with intermediate- and high-risk prostate cancer. Although more patients and longer follow-up are necessary to confirm the outcomes, these results suggested a hypothesis that proton beam therapy might not require androgen deprivation therapy in the treatment of localized prostate cancer, which could lead to a possibility of preserving of sexual function. Clinical trial information: MPTRC-N2 and N3.

Patient-Reported Sexual Aid Utilization and Efficacy After Radiation Therapy for Localized Prostate Cancer

Toreport sexual health-related quality of life outcomes and utilization and efficacy of sexual aids in a contemporary cohort of patients treated for localized prostate cancer. Between 2008 and 2013, 471 consecutive men with localized prostate cancer were treated on 2 institutional protocols (NCT01766492, NCT01618851) or on a prospective institutional registry with patient-reported health-related quality of life. All patients were treated with ultra-hypofractionated radiation therapy. Erectile function (EF) was defined as "firm enough for intercourse" with or without aids per Expanded Prostate Cancer Index Composite-26 (n = 222 at baseline); results apply to this cohort unless specifically noted. Sexual aid utilization and efficacy were patient reported. Multivariable analysis of EF was performed. Median follow-up was 60months, median age was 67years, and 70% had intermediate- or high-risk disease per National Comprehensive Cancer Network guidelines. At 24 and 60months, questionnaire response rates were 86% and 67%, and EF was retained in 53% and 41%, respectively. Baseline sexual aid utilization was 37% (n=82) and was associated with lower 24-month EF preservation on multivariable analysis (adjusted odds ratio 0.49, 95% confidence interval 0.26-0.92). By 60months, 70% of men had tried aids. Of those who found aids helpful at baseline, 84% to 89% reported continued benefit at 24 to 60months. Among aid-naïve patients, efficacy was 80% with first-time use within 12months and 70% more than 12months after radiation therapy (P=.02). Among men who developed erectile dysfunction but found sexual aids helpful, 25% were not current users at 60months. One-third of men used sexual aids at baseline, which doubled by 5years after radiation therapy. Self-reported efficacy was high and sustained. Despite significant declines in EF, a number of men reported helpfulness of aids but were not active users. Future study is required to understand drivers of aid utilization to optimize posttreatment sexual function.

Prospective longitudinal outcomes of quality of life after laparoscopic radical prostatectomy compared with retropubic radical prostatectomy

BackgroundThere have been few reports on health-related quality of life (HRQOL) after laparoscopic radical prostatectomy (LRP) in Japanese patients. The aim of this study is to assess changes in HRQOL during 36 months after LRP compared with retropubic radical prostatectomy (RRP).MethodsThe subjects were 105 consecutive patients treated with LRP between 2011 and 2012. HRQOL was evaluated using the International Prostate Symptom Score (IPSS), Medical Outcome Study 8-Items Short Form Health Survey (SF-8), and Expanded Prostate Cancer Index Composite (EPIC) at baseline and 1, 3, 6, 12 and 36 months after surgery. These results were compared with data for 107 consecutive patients treated with RRP between 2005 and 2007. The comparison between LRP and RRP was examined at every time point by Mann-Whitney U-test and chi-square test. Multiple linear regression analysis was used to identify independent factors related to the urinary domain in EPIC.ResultsThe IPSS change was similar in both groups. The LRP group had a better SF-8 mental component summary score at baseline and a better SF-8 physical component summary score at 1 month after surgery. In EPIC, urinary function and bother were worse after LRP, but improved at 12 months and did not differ significantly from those after RRP; however, these factors then worsened again at 36 months after LRP. Urinary incontinence was also worse at 36 months after LRP, compared to RRP. In patients treated with nerve-sparing surgery, urinary function and urinary incontinence were similar and good at 12 and 36 months in both groups. Bowel function and bother, and sexual function and bother were similar in both groups and showed no changes from 12 to 36 months. Age and salvage radiotherapy were independent predictors of incontinence (daily use of two or more pads) in multivariate analysis. Surgical procedure was not an independent factor for incontinence, but incontinence defined as use of one pad or more was associated with the surgical procedure.ConclusionsUrinary function and bother at 36 months were worse after LRP than after RRP. Age, salvage radiotherapy and surgical procedure were associated with urinary incontinence after 36 months.

Development of a Nationally Representative Coordinated Registry Network for Prostate Ablation Technologies

The accumulation of data through a prospective, multicenter coordinated registry network is a practical way to gather real world evidence on the performance of novel prostate ablation technologies. Urological oncologists, targeted biopsy experts, industry representatives and representatives of the FDA (Food and Drug Administration) convened to discuss the role, feasibility and important data elements of a coordinated registry network to assess new and existing prostate ablation technologies. A multiround Delphi consensus approach was performed which included the opinion of 15 expert urologists, representatives of the FDA and leadership from high intensity focused ultrasound device manufacturers. Stakeholders provided input in 3 consecutive rounds with conference calls following each round to obtain consensus on remaining items. Participants agreed that these elements initially developed for high intensity focused ultrasound are compatible with other prostate ablation technologies. Coordinated registry network elements were reviewed and supplemented with data elements from the FDA common study metrics. The working group reached consensus on capturing specific patient demographics, treatment details, oncologic outcomes, functional outcomes and complications. Validated health related quality of life questionnaires were selected to capture patient reported outcomes, including the IIEF-5 (International Index of Erectile Function-5), the I-PSS (International Prostate Symptom Score), the EPIC-26 (Expanded Prostate Cancer Index Composite-26) and the MSHQ-EjD (Male Sexual Health Questionnaire for Ejaculatory Dysfunction). Group consensus was to obtain followup multiparametric magnetic resonance imaging and prostate biopsy approximately 12 months after ablation with additional imaging or biopsy performed as clinically indicated. A national prostate ablation coordinated registry network brings forth vital practice pattern and outcomes data for this emerging treatment paradigm in the United States. Our multiple stakeholder consensus identifies critical elements to evaluate new and existing energy modalities and devices.

Impact of total fascia preservation on early recovery of urinary continence after radical prostatectomy

The objective was to investigate the effect of preserving the total fascia surrounding the prostate (lateral pelvic fascia (LPF) and posterior musculofascial plate) on the early return of urinary continence after three-dimensional laparoscopic radical prostatectomy (3D-LRP). Data from 70 consecutive patients who underwent 3D-LRP from April 2015 to February 2017 were collected prospectively and analyzed retrospectively. Patients were categorized into two groups: with or without LPF preservation; each group consisted of 35 consecutive patients. The rates of urinary continence within 12 weeks (no pad and no urinary leakage) were compared between groups using a 24-hour pad test and questionnaires of the Expanded Prostate Cancer Index Composite (EPIC). Immediately after Foley catheter removal, accumulated recovery rates of continence with the Kaplan–Meier method were 65.7% (23/35) and 14.3% (5/35) for LPF preservation and non-preservation groups, respectively. Four weeks after surgery, continence rates increased to 80% (28/35) and 20% (7/35), respectively. A log-rank test showed a statistical difference between groups ( p &lt; 0.001). The hazard ratio (HR) was 3.341 (95% confidence interval, 1.772–6.301). Our results demonstrated the effectiveness of total fascia preservation for the early recovery of urinary continence after radical prostatectomy. Level of evidence: Not applicable for this multicenter audit.

Health-related-quality-of-life and toxicity after single fraction 19 Gy high-dose-rate prostate brachytherapy: Phase II trial

PurposeTo evaluate the safety, tolerance and impact on health-related-quality-of-life (HRQoL) of the high-dose-rate brachytherapy of 19 Gy (BRT-HDR-19 Gy) single fraction in prostate cancer. MethodsFrom January 2014 to July 2016, 43 patients with low/intermediate risk were treated with BRT-HDR-19 Gy. The patients were monitored prospectively for toxicity and HRQoL. ResultsThe median age, initial PSA and the International Prostate Symptom Score (IPSS) were 71 years (55–78), 7.0 ng/mL (4.2–17.8) and 5 (0–14) respectively. 44% were low-risk and 56% intermediate-risk. Median CTV-V100 (where Vn is the fractional volume of the organ that receives n% of the prescribed dose) was 96.5%, Urethral-Dmax 106% and rectum-2 cc (the dose to 2 cc of rectal wall) 53%. After a median follow-up of 20 months (4–26), acute grade-2 genitourinary (GU) toxicity occurred in 4 patients (9%) and none presented acute gastrointestinal (GI) toxicity. Similarly, four patients (9%) presented late GU grade-2 toxicity. No grade-3 toxicity occurred.In terms of HRQoL, there was a statistically significant decline in Expanded Prostate Cancer Index Composite (EPIC) urinary urgency/obstructive domain at month 3 (p = 0.047), and returned to baseline by month 6. Mean EPIC urinary incontinence, bowel, sexual and hormonal domains did not present significant post BRT-HDR-19 Gy changes.Patients rated their satisfaction at 6 months as “very-satisfied” (23%) or “extremely-satisfied” (77%). ConclusionsBRT-HDR-19 Gy demonstrates excellent results in terms of toxicity, tolerance, safety, patient satisfaction and HRQoL.

Bowel and urinary quality of life after whole-pelvic versus prostate-only volumetric-modulated arc therapy for localized prostate cancer

PurposeThis study aimed to compare bowel and urinary health-related quality of life (HRQOL) between prostate-only (PO) volumetric modulated arc therapy (VMAT) and whole-pelvis (WP) VMAT in patients with localized prostate cancer. Methods and materialsA total of 234 patients treated with definitive VMAT to 78 Gy in 39 fractions were enrolled. Of these, 108 patients received PO-VMAT and 126 patients received initial WP-VMAT to 46.8 Gy in 26 fractions using a simultaneous integrated boost technique. HRQOL was prospectively assessed before radiation therapy (baseline), and 3, 6, 12, and 24 months after treatment using the Expanded Prostate Cancer Index Composite (EPIC). ResultsBaseline HRQOL scores did not differ significantly between the 2 groups. No significant between-group differences in HRQOL change from baseline were observed for all bowel and urinary EPIC domains. The proportion of patients showing a clinically relevant decrease in bowel and urinary HRQOL scores from baseline was similar between the groups throughout the follow-up period. An analysis of individual HRQOL items showed that patients undergoing WP-VMAT were more likely to report moderate/big problems with bloody stools (P = .039) and overall bowel problems (P = .008) than those undergoing PO-VMAT at 12 months. There was no significant between-group difference in any individual items at 24 months, however. ConclusionsBowel and urinary HRQOL is largely similar for patients receiving PO-VMAT and WP-VMAT during 24 months of follow-up, with the only differences seen in responses to specific bowel HRQOL items at 12 months.

Validation of the French-Canadian version of the Expanded Prostate Cancer Index Composite (EPIC) in a French-Canadian population.

This study aims to empirically validate the French-Canadian version of the Expanded Prostate Cancer Index Composite (EPIC), a measure of health-related quality of life for prostate cancer patients. Two hundred fifty-one participants completed a battery of self-report scales, including the French-Canadian version of the EPIC, after having received radiation therapy or radical prostatectomy for prostate cancer. The internal consistency for the urinary incontinence, bowel, and sexual domains of the EPIC-26 was high (Cronbach's alpha coefficients from 0.80-0.92), while coefficients for the urinary irritation/obstruction (0.59) and hormonal (0.67) domains were lower. Item-total correlations (rs=0.15-0.85), and temporal stability (rs=0.72-0.93) generally supported the reliability of the instrument. The five-factor structure of the EPIC-26 was confirmed for the most part. The construct validity of the instrument was also supported by high correlations obtained between each domain and measures assessing similar constructs (rs=-0.56-0.83). The EPIC also showed an excellent sensitivity to change with significant differences obtained on EPIC scores (all p<0.05) between pre- and post-prostate cancer treatment. The psychometric qualities of the French-Canadian version of the EPIC are well-supported, thus providing a valid tool to assess health-related quality of life in prostate cancer patients.