Expanded Prostate Cancer Index Research Articles

Discordance of patient- and physician-reported toxicities in two prospective trials of stereotactic body radiotherapy (SBRT) for localized prostate cancer.

245 Background: SBRT for localized prostate cancer (PCa) is the focus of several ongoing and reported high-impact trials, which often focus on physician-reported toxicity (P-Tox) when comparing regimens. Patient-reported quality of life (PR-QoL) may differ and provide a more sensitive comparative metric of treatment burden, especially with fewer provider interactions during SBRT than during protracted RT courses. We evaluated the concordance of prospective genitourinary (GU) and gastrointestinal (GI) P-Tox and PR-QOL in men receiving SBRT for PCa. Methods: Data from two concurrently-enrolled prospective trials of SBRT in high-risk (Phase I Safety Endpoint, NCT01896271) and low-intermediate risk (Phase II GI Toxicity Endpoint, NCT02353832) PCa were used. Matching standardized schedules of collected PR-QoL [Expanded Prostate Cancer Index Composite (EPIC)] and P-Tox (CTCAE v5.0) were analyzed over the first 18 months of follow up, where symptoms are most pronounced. We assessed concordance of Grade≥2 GU/GI physician reported toxicity with PR-QoL declines exceeding anchor based minimal clinically important difference (MCID) thresholds (-6 urinary and -5 bowel summary scores, respectively) for each patient at each time point. Patients without baseline PR-QoL data were excluded in full, while time points with missing PR-QoL or P-Tox were excluded individually without imputation. Concordance was evaluated by Cohen’s kappa statistic. Results: From 101 patients, there were 256 (64%) follow up observations through 18 months with both PR-QoL and P-Tox at the time point and baseline. Concordance of PR-QoL and P-Tox was low at all time points for both GU and GI toxicity domains (mean kappa 0.093; Table). MCID was more often reported by patients than Grade≥2 toxicity by physicians (38% vs 17% for GU and 44% vs 10% for GI). There was little overlap of PR-QoL and P-Tox reporting: Grade≥2 P-Tox reported in 17% of observations with MCID in PR-QoL, while MCID in PR-QoL reported in 54% of observations of Grade ≥2 P-Tox. Mean concordance was similarly low when analyzing sub-groups of trial, investigator, and an alternative 2xMCID threshold. Conclusions: P-Tox and PR-QoL differed dramatically in two prospective studies of SBRT despite toxicity primary endpoints. This may reflect subjective and varying intervention thresholds driving P-Tox reporting, rather than actual patient burden. These data strongly support use of PR-QoL rather than P-Tox for SBRT comparative study endpoints and guidelines in this rapidly evolving space. [Table: see text]

Real-world evidence of patient-reported outcomes following definitive radiation therapy for prostate cancer: Findings from an Australian population-based clinical outcomes registry.

244 Background: We aimed to evaluate patient-reported functional outcomes (PRO) following definitive radiation therapy (RT) for prostate cancer (PCa) in a real-life population-based setting. Methods: The population-based Victorian Prostate Cancer Outcomes Registry (PCOR-Vic) captures approximately 90% of all PCa cases in the state. From 2015 onwards, all men in PCOR-Vic were contacted to complete the Expanded Prostate Cancer Index Composite short-form 26 (EPIC-26) at 12-month post-treatment. The EPIC-26 included urinary incontinence, urinary obstructive, bowel, sexual and hormonal function domain scores, ranging from 0 to 100, with higher score representing better outcomes. We estimated differences in the EPIC-26 domain scores between different RT techniques using linear regression, adjusting for patient, tumor, and treatment related factors, including the use of androgen deprivation therapy (ADT). The nature of recruitment methods and data collection in PCOR-Vic precluded us from measuring EPIC-26 prior to treatment, and hence this was not adjusted for in our analyses. Results: Between 2015 and 2020, there were 1,898 men treated with definitive RT who completed the EPIC-26 questionnaires and were included in this study – 1551 (82%) had external beam radiation therapy (EBRT) alone, 91 (5%) had EBRT with brachytherapy boost (EBRT+BT), 204 (11%) had low-dose-rate brachytherapy (LDR-BT) alone, and 52 (3%) had high-dose-rate brachytherapy (HDR-BT) alone. There were 1,140 (60%) men who had ADT with RT – 68% with EBRT alone, 76% with EBRT+BT, 4% with LDR-BT, and 21% with HDR-BT (P < 0.001). Compared to men who had EBRT alone, men who had LDR-BT had higher adjusted mean EPIC-26 urinary incontinence (8.6 points; 95%CI: 5.3-12.0; P < 0.001), sexual (13.5 points; 95%CI: 9.2-17.8; P < 0.001) and hormonal score (6.8 points; 95%CI: 3.5-10.1; P < 0.001) at 12-month post-treatment. Compared to men who had EBRT alone, there were no statistically significant differences in all five EPIC-26 domain scores in men who had EBRT+BT or HDR-BT alone. Conclusions: This is the first Australian real-world evidence on PRO for different RT modalities for PCa on a population-based level. We observed better urinary incontinence, sexual and hormonal function in men who had LDR-BT compared to EBRT, but no significant differences between men who had EBRT, EBRT+BT or HDR-BT.

A Randomized Trial of the Effects of Exercise on Anxiety, Fear of Cancer Progression and Quality of Life in Prostate Cancer Patients on Active Surveillance.

We examined the effects of exercise on prostate cancer-specific anxiety, fear of cancer progression, quality of life and psychosocial outcomes in patients with prostate cancer on active surveillance. The ERASE (Exercise during Active Surveillance for Prostate Cancer) Trial randomized 52 patients with prostate cancer undergoing active surveillance to high-intensity interval training (HIIT, 26 patients) or usual care (UC, 26 patients). The HIIT group performed a 12-week, thrice weekly, supervised, aerobic HIIT program. The UC group did not exercise. Patient-reported outcomes were assessed at baseline and after intervention, including prostate cancer-specific anxiety (Memorial Anxiety Scale for Prostate Cancer), fear of cancer progression (Fear of Cancer Recurrence Inventory), prostate cancer symptoms (Expanded Prostate Cancer Index Composite), quality of life (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core) and psychological health outcomes (eg fatigue, stress and self-esteem). Analysis of covariance was used to compare between-group differences. Fifty of 52 participants (96%) completed patient-reported outcome assessments at 12 weeks. Adherence to HIIT was 96%. Compared to UC, HIIT significantly improved total prostate cancer-specific anxiety (adjusted between-group mean difference -2.7, 95% confidence interval, range -5.0 to -0.4, p=0.024), as well as the fear of progression subscale (p=0.013), hormonal symptoms (p=0.005), perceived stress (p=0.037), fatigue (p=0.029) and self-esteem (p=0.007). A 12-week supervised HIIT program may improve prostate cancer-specific anxiety, fear of cancer progression, hormone symptoms, stress, fatigue and self-esteem in men with prostate cancer on active surveillance. Larger trials are needed to confirm the effects of HIIT on patient-reported outcomes in the active surveillance setting.

Importance of considering interest in sex when evaluating satisfaction after robot-assisted radical prostatectomy.

To assess the impact of patients' interest in sex on the satisfaction after robot-assisted radical prostatectomy, longitudinal changes of urinary and sexual functions and bothers were evaluated. A total of 101 patients underwent robot-assisted radical prostatectomy in our institution. Based on sexual interest, they were divided into the high-interest and low-interest groups. Overall satisfaction, urinary function, urinary bother, sexual function, and sexual bother were evaluated using the expanded prostate cancer index composite questionnaire preoperatively and at 1, 3, 6, and 12 months after robot-assisted radical prostatectomy. We investigated the associations between the overall satisfaction and urinary function/urinary bother/sexual function/sexual bother scores (with higher score indicating better function and less impairment). In the high-interest group (n = 45), satisfaction correlated with high urinary function and urinary bother scores early after robot-assisted radical prostatectomy (urinary function: 1 and 3 months, urinary bother: 3 months postoperatively; P < 0.05) and then with high sexual bother score thereafter (sexual bother at 6 and 12 months after surgery; P < 0.05). Sexual function score did not correlate with satisfaction. In the low-interest group (n = 56), satisfaction correlated with high urinary function and urinary bother scores over time (urinary function: 3 and 6 months, urinary bother: at 3, 6 and 12 months postoperatively; P < 0.05). Neither sexual function nor sexual bother correlated with satisfaction postoperatively in the low-interest group. The impact of urinary and sexual functions and bothers on patients' overall satisfaction differed between patients with high- and low-interest in sex. The patient's interest in sex should be considered when assessing satisfaction after robot-assisted radical prostatectomy.

Creation and Psychometric Validation of the Sexual Minorities and Prostate Cancer Scale (SMACS) in Sexual Minority Patients-The Restore-2 Study

BackgroundExisting measures of sexual functioning in prostate cancer survivors focus primarily on erectile function and do not adequately measure the experiences of sexual minority men. AimTo develop and psychometrically evaluate a new scale to measure sexual functioning among sexual minority men with prostate cancer. MethodsSexual minority prostate cancer patients (n = 401) completed an online battery of urinary and sexual functioning tests in 2019, including a new 37-item instrument about their sexual functioning post-treatment for prostate cancer. OutcomesWe used confirmatory factor analysis to determine the construct validity of a new scale including five subscales: a four-factor model for all participants (n = 401) evaluated Sexual Satisfaction, Sexual Confidence, Frequency of Sexual Problems, and Urinary Incontinence in Sex. A single-factor model completed only by participants who had attempted or desired receptive anal sex (n = 255) was evaluated in the fifth subscale: Problematic Receptive Anal Sex. To evaluate criterion validity, we calculated the intercorrelations between each Sexual Minorities and Prostate Cancer Scale (SMACS) subscale and four related scales: the Expanded Prostate Cancer Index Composite-50 (EPIC), the Functional Assessment of Cancer Therapy-Prostate, the Brief Symptom Inventory-18, and the International Consultation on incontinence questionnaire. Cronbach's alphas were calculated to measure internal consistency (ie, reliability). ResultsCronbach's alpha values ranged from 0.64 to 0.89. Loadings (0.479–0.926) and model fit indices were strong (Root Mean Square Error of Approximation: 0.085, Standardized root mean squared residual: 0.063, comparative fit index: 0.927, Tucker-Lewis Index: 0.907). For criterion validity, Sexual Satisfaction, Sexual Confidence, and Frequency of Sexual Problems were moderately correlated with EPIC function and bother scores (r = 0.50–0.72) and Urinary incontinence in sex correlated moderately with EPIC Urinary Function and International Consultation on incontinence questionnaire scores (0.45–0.56). Clinical ImplicationsThe SMACS can be used by clinicians and researchers to comprehensively measure sexual functioning in sexual minority men, in conjunction with existing scales. Strengths and limitationsThis new scale is validated in a large, geographically diverse cohort of sexual minority cancer survivors and fills an important gap in existing measures of sexual functioning. Limitations include a lack of a validation sample. ConclusionThe SMACS is a valid and reliable new scale that measures sexual minority men's experience of urinary incontinence in sex, problematic receptive anal sex, and sexual distress.Polter EJ, Kohli N, Rosser BRS, et al. Creation and Psychometric Validation of the Sexual Minorities and Prostate Cancer Scale (SMACS) in Sexual Minority Patients-The Restore-2 Study. J Sex Med 2022;19:529–540.

Association between pelvic nodal radiotherapy and patient-reported functional outcomes through 5 years among men undergoing external-beam radiotherapy for prostate cancer: An assessment of the comparative effectiveness analysis of surgery and radiation (CEASAR) cohort.

The role of pelvic irradiation in men receiving external beam radiotherapy (EBRT) for prostate cancer is unclear, in part due to a lack of data on patient-reported outcomes. We sought to compare functional outcomes for men receiving prostate and pelvic versus prostate-only radiotherapy, longitudinally over 5 years. We performed a population-based, prospective cohort study of men with clinically-localized prostate cancer undergoing EBRT. We examined the effect of prostate and pelvic (n = 102) versus prostate-only (n = 485) radiotherapy on patient-reported disease-specific (using the Expanded Prostate Cancer Index Composite[EPIC]-26) and general health-related (using the SF-36) function, over 5 years. Regression models were adjusted for outcome-specific baseline function, clinicopathologic characteristics, and androgen deprivation therapy (ADT). 587 men (median [quartiles] age 69 [64-73] years) met inclusion criteria and completed ≥1 post-treatment survey. More men treated with prostate and pelvic radiotherapy had high-risk disease (58% vs. 18%, P < 0.01) and received ADT (75% vs. 41%, P < 0.01). These men reported worse sexual (6 months-5 years), hormonal (at 6 months), and physical (6 months-5 years) function. Accounting for baseline function, patient and tumor characteristics, and use of ADT, pelvic irradiation was not associated with statistically or clinically significant differences in bowel function, urinary incontinence, irritative voiding symptoms or sexual function through 5-years (all P > 0.05). Marginally clinically important differences were noted in hormonal function at 3-years (adjusted mean difference 4.7, 95% confidence interval [1.2-8.3]; minimally clinically important difference (MCID) 4 to 6) and 5-years (4.2, [0.4-8.0]) following treatment. After adjustment, there was a transient statistically significant, but not clinically important, difference in emotional well-being at 6 months (3.0, [0.19-5.8]; MCID 6) that resolved by 1 year and no differences in physical functioning or energy and fatigue. This prospective, population-based cohort study of men with localized prostate cancer treated with EBRT, showed no clinically important differences in disease-specific or general health-related quality of life with the addition of pelvic irradiation to prostate radiotherapy, supporting the use of pelvic radiotherapy when it may be of clinical benefit, such as men with increased risk of nodal involvement.

Impacts of Neoadjuvant Hormonal Therapy Prior to Robot-Assisted Radical Prostatectomy on Postoperative Hormonal- and Sexual-Related Quality of Life - Assessment by Patient-Reported Questionnaire.

PurposeNeoadjuvant hormonal therapy (HT) before radical prostatectomy (RP) is not recommended by current guidelines in terms of oncological outcomes. Despite this, neoadjuvant HT is sometimes conducted before RP for a small proportion of patients in clinical practice. This study evaluated the impacts of neoadjuvant HT on hormonal- and sexual-related quality of life (QOL) among patients who underwent robot-assisted RP (RARP).Materials and MethodsParticipants comprised 470 patients divided into a non-neoadjuvant HT group (n = 408) and a neoadjuvant HT group (n = 62). Hormonal- and sexual-related QOL were measured using the Expanded Prostate Cancer Index Composite (EPIC) questionnaire.ResultsHormonal summary scores at 6 and 9 months, function scores before and 3, 6, and 9 months and bother score at 6 months after RARP were significantly lower in the neoadjuvant HT group than in the non-neoadjuvant HT group. Sexual function scores were decreased in the neoadjuvant HT group compared to the non-neoadjuvant HT group before and 6 months after RARP. In the neoadjuvant HT group, sexual function at 3 months after RARP was significantly worse in patients with >5 months of neoadjuvant HT than in patients with ≤5 months of neoadjuvant HT. Conversely, sexual bother at 3 months after RARP was significantly worse in patients with ≤5 months of neoadjuvant HT than in patients with >5 months of neoadjuvant HT.ConclusionVintage neoadjuvant HT prior to RARP should not be recommended due to not only oncological outcomes, but also the impacts on postoperative hormonal- and sexual-related QOL.

Long-term satisfaction with curative treatment and follow-up in prostate cancer survivors

Purpose In a cross-sectional observational study to explore long-term satisfaction with treatment among men who had undergone radical prostatectomy (RP) or definitive pelvic radiotherapy (RT) for prostate cancer (PCa). Methods After mean 7 years from therapy (range: 6–8), 431 PCa-survivors (RP: n = 313, RT: n = 118) completed a mailed questionnaire assessing persistent treatment-related adverse effects (AEs) (Expanded Prostate cancer Index Composite [EPIC-26]) and seven Quality indicators describing satisfaction with the health care service following a most often general practitioner (GP)-led follow-up plan. A logistic regression model evaluated the associations between long-term satisfaction and treatment modality, age, the seven satisfaction-related Quality indicators, and persistent AEs. The significance level was set at p< .05. Results Four of five (81%) PCa-survivors reported long-term satisfaction with their treatment. In a multivariable model, satisfaction was positively associated with sufficient information about treatment and AEs, patient-perceived sufficient cooperation between the hospital and the GP and sufficient follow-up of AEs (ref.: insufficient). Age ≥70 years (ref.: <70) and a rising summary score within the EPIC-26 sexual domain additionally increased long-term satisfaction. The treatment modality itself (RP versus RT) did not significantly impact on satisfaction. Conclusions The majority of curatively treated PCa-survivors are satisfied with their treatment more than 5 years after primary therapy. Sufficient information, improved cooperation between the hospital specialists and the responsible GP and optimized follow-up of AEs may further increase long-term satisfaction among prostatectomized and irradiated PCa-survivors.

Patient-Reported Quality of Life Outcomes after Moderately Hypofractionated and Normofractionated Proton Therapy for Localized Prostate Cancer.

Simple SummaryFor patients with localized prostate cancer (PCa), information on the quality of life (QOL) after treatment is important when determining their preferred treatment option. In external beam radiation therapy, moderate hypofractionation (MH) is becoming an alternative standard for PCa treatment and MH is increasingly used in proton therapy (PT). Although MHPT is a promising strategy, there is little evidence regarding the data of long-term QOL after MHPT. This study evaluated patient-reported QOL over three years after MHPT and compared the data with that after normofractionated PT (NFPT) using the Expanded Prostate Cancer Index Composite-50. We revealed urinary QOL was temporarily decreased with clinically meaningful changes at 1 month, but did not observe clinically meaningful QOL deterioration in other assessment points in the urinary, bowel, and sexual domains over three years after MHPT. In addition, the QOL after MHPT and NFPT was similar overall.We retrospectively evaluated the three-year patient-reported quality of life (QOL) after moderately hypofractionated proton therapy (MHPT) for localized prostate cancer in comparison with that after normofractionated PT (NFPT) using the Expanded Prostate Cancer Index Composite-50. Patients who received MHPT (60–63 Gy (relative biological effectiveness equivalents; RBE)/20–21 fractions) (n = 343) or NFPT (74–78 Gy (RBE)/37–39 fractions) (n = 296) between 2013 and 2016 were analyzed. The minimum clinically important difference (MCID) threshold was defined as one-half of a standard deviation of the baseline value. The median follow-up was 56 months and 83% completed questionnaires at 36 months. Clinically meaningful score deterioration was observed in the urinary domain at 1 month in both groups and in the sexual domain at 6–36 months in the NFPT group, but not observed in the bowel domain. At 36 months, the mean score change for urinary summary was −0.3 (MHPT) and −1.6 points (NFPT), and that for bowel summary was +0.1 and −2.0 points; the proportion of patients with MCID was 21% and 24% for urinary summary and 18% and 29% for bowel summary. Overall, MHPT had small negative impacts on QOL over three years, and the QOL after MHPT and NFPT was similar.

Hematuria following Post-Prostatectomy Radiotherapy: Incidence Increases with Long-Term Followup.

Hematuria following post-prostatectomy radiotherapy (PPRT) is inadequately characterized. We performed a consecutive cohort study of patients treated with PPRT at our institution to characterize this complication including impact on patient-reported quality of life. Patients with potential followup ≥4 years following PPRT were identified. Freedom from ≥grade 2 hematuria (FFG2H; macroscopic blood) was estimated using the Kaplan-Meier method. Predictors of ≥grade 2 hematuria (G2H) were assessed via log-rank tests and the Cox model. Urinary patient-reported quality of life by EPIC-26 (26-question Expanded Prostate Cancer Index Composite) was compared for patients with/without hematuria using mixed-effects regression. A total of 216 men received PPRT (median 68.4 Gy, IQR 68.0-68.4) from 2007 to 2016 at a median of 20 months (IQR 9-45) after prostatectomy. Median followup was 72 months (IQR 54-99). A total of 85 men developed hematuria, of whom 49 (58%) underwent cystoscopy, 13 (15%) required intervention and 26 (31%) experienced recurrent hematuria. Eight-year FFG2H was 55%. G2H was highest in men treated with anticoagulation/antiplatelet therapy (HR 3.24, p <0.001), men with bladder V65 Gy ≥43% (HR 1.97, p=0.004) and men with medication allergies (HR 1.73, p=0.049). Age <65 years (HR 0.81, p=0.374) and diabetes mellitus (HR 0.49, p=0.098) were not associated with G2H. Change in urinary continence (mean -3.5, 95% CI: 10.1, 3.1) and irritation/obstruction (mean -3.0, 95% CI: 5.8, -0.3) domain scores did not exceed the minimally clinically important difference for men with/without hematuria. Hematuria following PPRT is common, especially among men with medication allergies and those on anticoagulation/antiplatelet therapy; however, PPRT-related hematuria is typically self-limited. Limiting bladder V65 Gy may reduce PPRT-related hematuria.

Effect of Brachytherapy vs. External Beam Radiotherapy on Sexual Function in Patients With Clinically Localized Prostate Cancer: A Meta-Analysis.

Purpose: The aim of this study was to compare the effect of brachytherapy (BT) versus external beam radiotherapy (EBRT) on sexual function in patients with localized prostate cancer (PCa). Methods: Data were retrieved from the PubMed, Cochrane Library, Embase, China National Knowledge Infrastructure (CNKI), and Wanfang Database until March 4, 2021. Analysis was performed by using RevMan 5.4.1. The main clinical outcomes were the Prostate Cancer Symptom Indices (PCSI) scale and the Expanded Prostate Cancer Index Composite (EPIC) scale scores for sexual function. A meta-analysis was performed to calculate standardized mean differences (SMDs) and their 95% CI. This study has undergone PROSPERO registration (No. CDR42021245438). Results: Among the 962 studies retrieved, eight prospective cohort studies met the inclusion criteria, covering a total of 2,340 patients, including 1,138 treated with BT alone and 1,202 treated with EBRT alone. The results demonstrated that BT was to some extent advantageous over EBRT in overall sexual function scores in patients with localized PCa during the immediate post-treatment period (SMD = −0.09, 95% CI: −0.18 to −0.01, p = 0.03), but this difference was not detectable at 3 months (SMD = −0.07, 95% CI: −0.18–0.05, and p = 0.25), 12 months (SMD = −0.01, 95% CI: −0.21–0.20, and p = 0.96), and 24 months (SMD = −0.09, 95% CI: −0.20–0.01, and p = 0.09) after treatment. Conclusion: Our analysis showed that BT showed a short-term advantage over EBRT in terms of sexual function in patients with localized PCa, but this difference diminished over time, though the conclusion needs to be further verified by a longer-term follow-up study.

Nonrandomized Comparison of Efficacy and Side Effects of Bicalutamide Compared With Luteinizing Hormone-Releasing Hormone (LHRH) Analogs in Combination With Radiation Therapy in the CHHiP Trial

PurposeCHHiP is a randomized trial evaluating moderately hypofractionated radiation therapy for treatment of localized prostate cancer. Of all participants, 97% of them had concurrent short-course hormone therapy (HT), either luteinizing hormone-releasing hormone analog (LHRHa) or 150 mg of bicalutamide daily. This exploratory analysis compares efficacy and side effects in a nonrandomized comparison. Methods and MaterialsIn our study, 2700 patients received LHRHa and 403 received bicalutamide. The primary endpoint was biochemical/clinical failure. Groups were compared with Cox regression adjusted for various prognostic factors and stratified by radiation therapy dose. A key secondary endpoint was erectile dysfunction (ED) assessed by clinicians (using scores from Late Effects on Normal Tissues: Subjective/Objective/Management [LENT-SOM] subjective erectile function for vaginal penetration) and patients (single items within the University of California-Los Angeles Prostate Cancer Index [UCLA PCI] and Expanded Prostate Cancer Index Composite [EPIC]-50 questionnaires) at 2 years and compared between HT regimens by χ2 trend test. ResultsBicalutamide patients were significantly younger (median 67 vs 69 years LHRHa). Median follow-up was 9.3 years. There was no difference in biochemical or clinical failure with an adjusted hazard ratio or 0.97 (95% confidence interval, 0.77-1.23; P = .8). At 2 years, grade ≥2 LENT-SOM ED was reported in significantly more LHRHa patients (313 out of 590; 53%) versus bicalutamide (17 out of 68; 25%) (P < .0001). There were no differences in ED seen with UCLA-PCI and EPIC-50 questionnaires. ConclusionsIn this nonrandomized comparison, there was no evidence of a difference in efficacy according to type of HT received. Bicalutamide preserved clinician assessed (LENT-SOM) erectile function at 2 years but patient-reported outcomes were similar between groups.

Acupuncture for prostatectomy incontinence: study protocol for a multicenter single-blind randomized parallel controlled trial

BackgroundUrinary incontinence is a common complication post radical prostatectomy. Acupuncture is considered an effective treatment for post-prostatectomy incontinence (PPI), but the evidence is still limited. We propose to evaluate the effectiveness of acupuncture in a rigorously conducted trial.MethodsTwenty hospitals will recruit 340 participants with urinary incontinence after radical prostatectomy in China from April 2021 to April 2022. Participants will be randomly allocated to acupuncture or sham acupuncture with a 1:1 ratio using computerized simple random sampling. The study plan consists of 1-week baseline, 6-week treatment, and 18-week follow-up. Eighteen 30-min sessions of acupuncture or sham acupuncture treatment will be provided between weeks 1 and 6. The primary outcome is the change in the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF) score at the week 6 from the baseline. Secondary outcomes include the change in volume of urine leakage at weeks 4 and 6 from a baseline measured using the 1-h pad test; 72-h incontinence episode frequency based on a 72-h voiding diary; change in the Expanded prostate cancer Index Composite scale (EPIC-26); change in the Self-Rating Anxiety Scale; weekly consumption of pads; and the severity of urinary incontinence based on a 72-h bladder diary and self-assessment of the therapeutic effect. The safety of acupuncture will also be assessed.DiscussionThis trial will help to identify whether acupuncture is effective for PPI, and, if so, whether it exerts a therapeutic rather than a placebo effect.Trial Registrationwww.Chictr.org.cnChiCTR2100042500. Retrospectively registered on 22 January 2021.

How Does Age Affect Urinary Continence following Robot-Assisted Radical Prostatectomy? A Prospective Multi-Institutional Study Using Independently Collected, Validated Questionnaires.

Robot-assisted radical prostatectomy (RARP) is associated with poorer postoperative urinary continence in older men. However, published studies reporting conflicting results have design limitations with insufficient data at the extremes of age. The purpose of this study was to assess the effect of age on post-RARP urinary continence. This study included 5,648 patients from 2 prospective Australian databases who underwent a primary RARP for prostate cancer between 2008 and 2019. Significant urinary bother and pad-usage were evaluated 12 months post-RARP by EPIC-26 (Expanded Prostate Cancer Index Composite) questionnaires, independently collected by third parties. Multivariable logistic regression was used to investigate the relationship between continence and age. Percentages of significant bother increased with age: 4.2%, 6.8% 9.1% and 12.9% at age groups <55, 55-64, 65-74 and ≥75 years, respectively. Compared with men aged 65-69 years, the odds of significant bother in patients <55 years was significantly lower (odds ratio [OR] 0.49, 95% confidence interval [CI] 0.32-0.75, p=0.001). Corresponding OR found no significant difference in bother in patients ≥70 (OR 1.24, 95% CI 0.94-1.63, p=0.13) or ≥75 years (OR 1.41, 95% CI 0.88-2.25, p=0.16). Pad-free rates markedly decreased with age: 86%, 79%, 68% and 50% at ages, <55, 55-64, 65-74 and ≥75 years, respectively. Corresponding social continence (0-1 pads/day) rates also decreased with age: 98%, 96%, 92% and 85%. Urinary bother and pad-usage post-RARP are excellent in young men but worsen with age. Older patients were only slightly more likely to be "significantly bothered" by incontinence despite higher pad-usage.

Sexual Function of Men Undergoing Active Prostate Cancer Treatment Versus Active Surveillance: Results of the Europa Uomo Patient Reported Outcome Study

Background: Europa Uomo initiated the Europa Uomo Patient Reported Outcome Study (EUPROMS) to inform future patients with prostate cancer about the impact of prostate cancer treatment on sexual function. Methods: A one-time online survey was conducted among patients with prostate cancer who underwent treatment for the disease. The survey included the Expanded Prostate Cancer Index Composite short form 26 (EPIC-26) and questions on the use of medications or devices to aid/improve erections in men. Descriptive statistics were used to analyse the EPIC-26 sexual domain and the use of medications or devices. Results: Men on active surveillance reported the highest median sexual function scores (57.0, interquartile range [IQR]: 26.3–83.3) compared with men who underwent radical prostatectomy (20.8, IQR: 8.3–44.5) or radiotherapy (17.3, IQR: 9.7–40.3). Of the men on active surveillance, 44.7% reported “very poor to none/poor ability” to have an erection compared with 71.7–88.2% of the men undergoing active treatment for prostate cancer. Of the men treated actively, 66.6–88.3% rated their ability to function sexually as “very poor/poor” compared with 43.1% for men on active surveillance; more than half of the men who underwent radical prostatectomy viewed their lack of sexual function as a moderate or big problem for which they had tried medications or devices. Conclusions: The EUPROMS study showed that the impact of prostate cancer treatment on sexual function can be significant and non-negligible. These data can be used in daily clinical practice to guide the preference-sensitive decisionmaking process faced by patients newly diagnosed with prostate cancer.

Mirabegron Reduces Urinary Frequency and Improves Overactive Bladder Symptoms at 3 Months After 125I-brachytherapy for Prostate Cancer: An Open-Labeled, Randomized, Non–Placebo-Controlled Study

ObjectiveTo evaluate the additional effects of mirabegron to alpha-1 adrenergic antagonist on lower urinary tract symptoms of patients who underwent 125I-brachytherapy for prostate cancer. Patients and MethodsPatients who underwent 125I-brachytherapy for prostate cancer (cT1-cT3aN0M0) in a single institute between September 2016 and October 2018 were enrolled in the randomized, non-placebo, open-labeled, paralleled study. Patients were randomly distributed (1:1) to combination group (tamsulosin (0.2 mg/day) plus mirabegron (50 mg/day)) or tamsulosin-alone group after 125I -brachytherapy by envelope method. The primary endpoint was the change from baseline in mean voided volume per micturition 3 months after 125I brachytherapy. The secondary endpoints included the changes from baseline of International Prostate Symptom Score, Overactive Bladder Symptom Score, and Expanded Prostate Cancer Index Composite scores and 24 hours urinary frequency after 3 months after 125I brachytherapy. ResultsThe mean changes in volume voided per micturition in the combination (n = 108) and tamsulosin-alone (n = 110) groups were −62.5 (standard deviation, ±53.8) and −68.0 (standard deviation, ±52.7), respectively (P = .17). The change in Overactive Bladder Symptom Score in combination group (P = .02) was more moderate than in tamsulosin-alone group; and 24 hour urinary frequency in combination group was lower (P = .03) than in tamsulosin-alone group. Retention rates within 3 months after 125I-brachytherapy in the mirabegron and tamsulosin-alone groups were 7.3% (9/122) and 6.0% (7/118), respectively (P = .80). ConclusionTamsulosin and mirabegron combination therapy after 125I-brachytherapy did not improve voided volume per micturition compared to tamsulosin-only treatment. However, it could improve frequent urination and overactive bladder symptoms.

Low-risk prostate cancer: evaluation of quality of life after surgical treatment and during active observation

The study objective is to improve results of treatment of patients with low-risk prostate cancer (PC).Materials and methods. In the study, comparative analysis of data from 84 patients with low-risk PC was performed: 40 patients were included in the active observation group (group 1) and 44 patients underwent radical prostatectomy (group 2). For evaluation of functional responses the following questionnaires were used: Short Form 36 Health Quality Survey (SF-36), International Index of Erectile Function (IIEF-5), International Prostate Symptom Score (IPSS), Expanded Prostate Cancer Index Composite (EPIC-26). For control of oncological results, tests for prostate-specific antigen, digital rectal examination, magnetic resonance imaging of the pelvic organs with intravenous contrast, and confirmation biopsy of the prostate were preformed.Results. Mean score for the SF-36 questionnaire in the group 1 (active observation) at the beginning of the study was 63.2 ± 11.5 for mental health (MH) and 57.1 ± 9.8 for physical health (PH), while in the group 2 MH score was 63.1± 6.8, PH score was 56.2 ± 8.6. However, 18 months later in the group 1 mean MH score increased to 68.2 ± 10.1, mean PH score to 62.4 ± 7.8; in the group 2 PH score increased insignificantly to 64.2 ± 7.4 and PH score decreased to 54.8 ± 5.4 (p &lt;0.05). IIEF-5 score in the group 1 decreased from 18.8 ± 4.2 to 18.3 ± 4.0, in the group 2 from 19.1 ± 4.3 to 16.9 ± 4.8 (p &lt;0.05). Mean IPSS score insignificantly increased in the group 1 from 9.1 ± 2.1 to 9.3 ± 2.7, while in the group 2 it decreased from 9.2 ± 2.3 to 8.4 ± 1.5 (p &lt;0.05). For the EPIC-26 questionnaire, mean score for all criteria initially was 56.1 ± 5.1 in the group 1 and 54 ± 4.4 in the group 2 (after prostatectomy), and currently it increased to 65 ± 4.6 in the group 1 and decreased to 49 ± 5.4 in the group 2.Two (5 %) patients from the group 1 underwent surgical treatment due to PC progression. One (2.5 %) patient chose surgical treatment due to cancer-related anxiety. Biochemical recurrence with an increase in prostate-specific antigen of 0.29 ± 0.09 ng/ml was observed in 3 (6,8 %) patients in the group 2.Conclusion. Strategy of active observation is the preferred method of care for patients with low-risk PC allowing to preserve high quality of life while surgical treatment should be performed only if necessary.

Patient- and Surgeon-Level Variation in Patient-Reported Sexual Function Outcomes Following Radical Prostatectomy Over 2 Years

Of patient-reported outcomes for individuals undergoing radical prostatectomy, sexual function outcomes are among the most reported and the most detrimental to quality of life. Understanding variations at the patient and surgeon level may inform collaborative quality improvement. To describe patient- and surgeon-level sexual function outcomes for patients undergoing radical prostatectomy in the Michigan Urological Surgery Improvement Collaborative (MUSIC) and to examine the correlation between surgeon case volume and sexual function outcomes. This is a prospective cohort study using the MUSIC registry and patient-reported sexual function outcome data. Patient- and surgeon-level variation in sexual function outcomes were examined among patients undergoing radical prostatectomy from May 2014 to August 2019. Sexual function outcome data were collected using validated questionnaires, which were completed before surgery and at 3, 6, 12, and 24 months' follow-up following surgery. All participants were male. Race and ethnicity data were self-reported and were included to examine potential variation in outcomes by race and/or ethnicity. Data were analyzed from January 2021 to March 2021. There were 4 outcomes in this study, including the 26-item Expanded Prostate Cancer Index Composite (EPIC-26) sexual function scores at 3, 6, 12, and 24 months' follow-up; patient-level sexual function recovery at 12- and 24-month follow-up; surgeon-level variation in sexual function outcomes at 12- and 24-month follow-up; and correlation between surgeon case volume and sexual function outcomes. A total of 1426 male patients met inclusion criteria for this study. The median (IQR) age was 64 (58-68) years. A total of 115 participants (8%) were Black, 1197 (84%) were White, 25 (2%) were of another race or ethnicity (consolidated owing to low numbers), and 89 (6%) were of unknown race or ethnicity. Among patients undergoing bilateral nerve-sparing radical prostatectomy, mean (SD) EPIC-26 sexual function scores at 12- and 24-month follow-up (12 months, 39 [28]; 24 months, 63 [29]) did not return to baseline levels. There was wide variation in EPIC-26 sexual function scores at both 12-month follow-up (range, 23-69; P < .001) and 24-month follow-up (range, 27-64; P < .001). Similar variations were found in EPIC-26 sexual function scores and recovery of sexual function by surgeon. Recovery rates ranged from 0% to 40% of patients at 12-month follow-up (18 surgeons; P < .001) and 3% to 44% of patients at 24-month follow-up (12 surgeons; P < .001). Surgeon case volume and sexual function outcomes were not significantly correlated. On multivariable analysis, the following variables were associated with better recovery at 24-month follow-up: younger age (P < .001), lower baseline EPIC-26 sexual function score (P < .001), lower Gleason score (P = .05), and nonobesity (P = .03). In this study, there was significant patient- and surgeon-level variation in sexual function recovery over 2 years following radical prostatectomy. Variation in surgeon-level sexual function outcomes presents an opportunity and model for surgical collaborative quality improvement.

Creation and validation of the harmonized Arabic version of the Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP)

ABSTRACT Objectives Tocreate and validate a translated Arabic version of the Expanded Prostate Cancer Index Composite for Clinical Practice (EPIC-CP), a validated patient-reported outcome (PRO) widely used for assessing the quality of life in patients with prostate cancer (PCa). Patients and Methods Using the established protocol as defined by the Professional Society for the Health Economics and Outcomes Research (ISPOR) for translating patient care questionnaires, a harmonised translated Arabic version of EPIC-CP was created. The questionnaire was tested in native Arabic speakers from four different Arabic countries (Saudi Arabia, United Arab Emirates, Jordan, and Kuwait). Cronbach’s alpha and interclass coefficient correlation (ICC) analyses were used to test the internal consistency and test–retest reliability, respectively. In addition, PCa characteristics were collected for participants. Results In total, 168 patients with PCa participated in the study (39 from Saudi Arabia, 23 from United Arab Emirates, 65 from Jordan, and 41 from Kuwait). In all, 52 (31%) participants repeated the questionnaire for test–retest reliability analysis. The median (interquartile range [IQR]) age of patients included in the study was 66 (61–71) years. The median (IQR) PSA level was 9.8 (6–19) ng/mL. Most patients had Grade Group 2 PCa at diagnosis (31%), clinical stage cT1 (42%), managed primarily by urology (79%), and the primary treatment was radical prostatectomy (71%). The total Cronbach’s alpha coefficient was 0.84 demonstrating an acceptable internal consistency. The total ICC was also acceptable at 0.64. Conclusion The Arabic version of the EPIC-CP is a reliable and valid tool for assessing health-related quality of life for Arabic patients with PCa.

Cosmetic Appeal, HRQoL, and Effectiveness of Simple and Pseudotesticular Techniques of Orchidectomy in Prostate Cancer.

Introduction Orchidectomy is the most cost-effective means of hormonal therapy for locally advanced or metastatic prostate cancer (LAMP). However, cost-effectiveness should not detract from health-related quality of life (HRQoL) considerations. Bilateral simple orchidectomy (BSO) has been linked to negative psychometric deficits from an empty scrotum. This study compared the HRQoL, therapeutic efficacy, and cosmetic appeal of BSO with endogenous pseudotesticular techniques of bilateral subcapsular orchidectomy (BSCO) and bilateral-epididymal-sparing orchidectomy (BESO). Research Design. Nigerian patients with LAMP were randomised into three surgical arms: BSO, BSCO, and BESO. Expanded Prostate Cancer Index Composite-26 HRQoL and sociodemographic questionnaires were administered before and three months after orchidectomy. Serum testosterone and PSA were measured at 0, 1, 2, and 3 hours; 7 days; and 3 months postoperatively. Pseudotesticular volumes and cosmetic appeal were assessed at 3 months. Result Sixty-three patients were recruited (24 BSO, 21 BSCO, 18 BESO), 73% of whom were low-income earners. There was no significant difference in the procedure cost nor the PSA or testosterone nadirs achieved over the three-month follow-up period (11.3, 12.6, 15.2 ng/ml (p=0.667) and 0.44, 0.64, 0.79 nmol/l (p=0.603) respectively). Those with pseudotesticles (BSCO, BESO) felt less emasculated (p=0.010). BSCO produced the least sexual bother, highest sexual function, and largest pseudotesticular volumes. The cosmetic appeal scores were similar between groups (77.9 ± 22.8, 81 ± 13.9, and 81.9 ± 22.5, respectively, p=0.858). Conclusion Endogenous pseudotesticular techniques, when compared with BSO, reduce the negative psychological impact experienced by patients without increasing costs. BSCO produced the best pseudotesticular volumes and postoperative sexual function. This study is registered with the ClinicalTrials.gov of the National Institute of Health U.S. National Library of Medicine as TEPSO study, NCT03744494: Comparison of the Therapeutic Efficacy and Patient Satisfaction of Three Techniques of Bilateral Orchidectomy in Prostate Cancer Patients of a Nigerian Sub-population. Registration completed on 16th of November, 2018 (registered retrospectively) NCT03744494.