Cancer Index Composite Short Form Research Articles

Urinary incontinence after radical prostatectomy for prostate cancer-data from 17,149 patients from 125 certified centers

In addition to erectile dysfunction, urinary incontinence is the most common functional limitation after radical prostatectomy (RPE) for prostate cancer (PCa). The German S3guideline recommends informing patients about possible effects of the therapy options, including incontinence. However, only little data on continence from routine care in German-speaking countries after RPE are currently available, which makes it difficult to inform patients. The aim of this work is to present data on the frequency and severity of urinary incontinence after RPE from routine care. Information from the PCO (Prostate Cancer Outcomes) study is used, which was collected between 2016 and 2022 in 125 German Cancer Society (DKG)-certified prostate cancer centers in 17,149 patients using the Expanded Prostate Cancer Index Composite Short Form (EPIC-26). Changes in the "incontinence" score before (T0) and 12months after RPE (T1) and the proportion of patients who used pads, stratified by age and risk group, are reported. The average score for urinary incontinence (value range: 0-worst possible to 100-best possible) was 93points at T0 and 73points 12months later. At T0, 97% of the patients did not use apad, compared to 56% at T1. 43% of the patients who did not use apad before surgery used at least one pad aday12months later, while 13% use two or more. The proportion of patients using pads differs by age and risk classification. The results provide acomprehensive insight into functional outcome 12months after RPE and can be taken into account when informing patients.

Urinary Incontinence and Sexual Function After the Introduction of NeuroSAFE in Radical Prostatectomy for Prostate Cancer

BackgroundNerve-sparing (NS) radical prostatectomy (RP) results in better functional outcomes. Intraoperative neurovascular structure–adjacent frozen section examination (NeuroSAFE) significantly increases the frequency of NS surgery. The effect of NeuroSAFE on postoperative erectile function (EF) and continence is not yet clear. ObjectiveTo describe EF and continence outcomes for men undergoing RP with the NeuroSAFE technique. Design, setting, and participantsBetween September 2018 and February 2021, 1034 men underwent robot-assisted RP. Data for patient-reported outcomes were collected via validated questionnaires. InterventionNeuroSAFE technique for RP. Outcome measurements and statistical analysisContinence was assessed using the International Consultation on Incontinence Questionnaire-Urinary Incontinence Short Form (ICIQ-UI SF) or Expanded Prostate Cancer Index Composite short form (EPIC-26) and defined as use of 0–1 pads/d. EF was evaluated using EPIC-26 or the International Index of Erectile Function short form (IIEF-5), with data converted according to the Vertosick method and categorized. Descriptive statistics were used to asses and describe tumor characteristics and continence and EF outcomes. Results and limitationsOf the 1034 men who underwent RP after introduction of the NeuroSAFE technique, 63% and 60% completed a preoperative and at least one postoperative questionnaire on continence and EF, respectively. Of the men who underwent unilateral or bilateral NS surgery, use of 0–1 pads/d was reported by 93% after 1 yr and 96% after 2 yr; the corresponding rates for men who underwent non-NS surgery were 86% and 78%. Overall, use of 0–1 pads/d was reported by 92% of the men at 1 yr and by 94% at 2 yr after RP. Men in the NS group had a good or intermediate Vertosick score after RP more often than the non-NS group. Overall, 44% of the men had a good or intermediate Vertosick score at 1 and 2 yr after RP. ConclusionsAfter introduction of the NeuroSAFE technique, the continence rate was 92% at 1 yr and 94% at 2 yr after RP. The NS group had a greater percentage of men with an intermediate or good Vertosick score and a higher continence rate after RP in comparison to the non-NS group. Patient summaryOur study shows that after introduction of the NeuroSAFE technique during removal of the prostate, the continence rate among patients was 92% at 1 year and 94% at 2 years after surgery. Some 44% of the men had a good or intermediate score for erectile function 1 and 2 years after surgery.

Open retropubic radical prostatectomy versus external beam radiation therapy for localized prostate cancer - patient-reported outcomes

Introduction/Objective. Active treatment options for localized prostate cancer (LPCa) include surgery and radiotherapy with androgen deprivation therapy (ADT) in selected cases, but all options have side effects, mainly addressed to urinary, sexual, and bowel function. Our study aimed to assess and compare patient-reported outcome measures (PROMs) after open retropubic radical prostatectomy (ORRP) or external beam radiotherapy (EBRT). Methods. Between June 2019 and May 2021, a total of 120 patients, with LPCa had undergone active treatment, as follow: ORRP ? 60 patients and EBRT ? 60 patients. A validated questionnaire, the Expanded Prostate Cancer Index Composite Short Form (EPIC-26) instrument was used to assess PROM, through the following domains: urinary, sexual and bowel. Patients completed a questionnaire at baseline and six, 12, and 24 months after primary treatment. Results. All urinary scores had statistically significant interaction between time and group. After six, 12, and 24 months, all urinary scores were statistically significantly lower in the ORRP group. After 12 and 24 months, bowel score values were statistically significantly lower in patients in the ERBT group. Sexual scores change statistically significant during the follow-up period, without difference between the groups (p < 0.05). Conclusion. Both ORRP and EBRT are associated with decline of sexual scores. ORRP showed significant variations in all urinary scores, with more pronounced negative impact on urinary symptoms compared to EBRT during the entire follow-up period. Bowel scores are lower in EBRT.

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.

The expanded prostate cancer index composite short form (EPIC-26) for measuring health-related quality of life: content analysis of patients\u2019 spontaneous comments written in survey margins

IntroductionThis study investigates comments that prostate cancer patients spontaneously write in the margins of the Expanded Prostate Cancer Index Short Form (EPIC-26) questionnaire. We aim to show the possible barriers that patients face while answering the survey, and to consider how these barriers may affect the response data generated. We investigate the kind of information patients’ comments on EPIC-26 contain, and patients’ motivations to provide this information. We also study why some EPIC domains spark more comments than others.MethodWe analyzed 28 pages of transcribed comments and four pages of supplementary letters from our survey participants (n = 496). Using inductive content analysis, we generated 10 categories describing the content of participants’ comments, and four themes demonstrating their motives for commenting. The comments regarding each EPIC domain were quantified to discover any differences between domains.ResultsThe sexual domain of EPIC-26 provoked over half of all comments. Patients without recent sexual activity or desire had difficulties answering sexual function questions 8–10. The lack of instructions on whether to take erectile aid use into account when answering erectile function questions led to a diversity of answering strategies. Patients with urinary catheters could not find suitable answer options for questions 1–4. All domains sparked comments containing additional information about experienced symptoms.ConclusionPatients are mainly willing to report their symptoms, but a lack of suitable answer options causes missing data and differing answering strategies in the sexual and urinary domains of EPIC-26, weakening the quality of the response data received.

Europa Uomo Patient Reported Outcome Study (EUPROMS): Descriptive Statistics of a Prostate Cancer Survey from Patients for Patients

BackgroundEuropa Uomo initiated the Europa Uomo Patient Reported Outcome Study (EUPROMS) to collect prostate cancer (PCa) patient-reported outcome (PRO) data as a primary endpoint. ObjectiveTo inform future PCa patients about the impact of PCa treatment through self-reported PRO data of fellow patients collected outside a clinical trial setting. Design, setting, and participantsA cross-sectional survey was conducted among PCa patients currently receiving or having received treatment. The EUPROMS survey contained the EQ-5D-5 L (generic health), the EORTC-QLQ-C30 (cancer-specific quality of life (QoL), and the Expanded Prostate cancer Index Composite short form 26 (EPIC-26; prostate-specific health) questionnaires. Outcome measurements and statistical analysisDescriptive statistics were used to assess the demographic and clinical characteristics, and to analyze the PROs of EQ-5D-5L, EORTC-QLQ-C30, and EPIC-26. Results and limitationsBetween August 21 and November 19, 2019, 2943 men from 24 European countries completed the EUPROMS survey. The median age of the respondents was 71 yr (interquartile range 65–75 yr); 81.9% was living with a spouse. In total, 1937 (65.8%) men underwent a single treatment, and 636 (21.6%), 300 (10.2%), and 70 (2.4%) underwent two, three, and four treatments, respectively. Fatigue scores are highest for men who underwent radiotherapy or chemotherapy. Progression of disease leads to more insomnia. Surgery affects urinary incontinence the most. Self-reported sexual function amounts to 27/100, with the lowest scores being reported for men who underwent surgery and radiotherapy (15/100). Overall, patients who received two or more treatments reported lower scores for all indices. ConclusionsThe EUPROMS survey provided a cross-sectional picture of the current PCa patient population and their reported QoL. Initial treatment is often followed by subsequent treatments, affecting mainly sexual function, as well as fatigue and insomnia. QoL of men undergoing chemotherapy is worse for almost all domains. These data can inform physicians and patients on the true impact of PCa treatment. Patient summaryPatient-reported quality of life in the Europa Uomo Patient Reported Outcome Study (EUPROMS) survey—a more informal setting as compared with clinical trials—reveals that prostate cancer treatment affects mainly sexual function, fatigue, and insomnia.

Fifteen year quality of life outcomes in men with localised prostate cancer: population based Australian prospective study

ObjectiveTo assess treatment related changes in quality of life up to 15 years after diagnosis of localised prostate cancer.DesignPopulation based, prospective cohort study with follow-up over 15 years.SettingNew South Wales,...

Baseline patient reported outcomes data shows high prevalence of overactive bladder, sexual dysfunction, depression and anxiety in Canadian men with newly diagnosed localized prostate cancer.

BackgroundResearch on prostate cancer survivorship patients has largely been on oncological outcome, incontinence and erectile dysfunction, with less data on the relationship between prostate cancer, bladder function and mental health. This study aims to elucidate the prevalence of lower urinary tract symptoms (LUTS), overactive bladder (OAB), sexual dysfunction, depression and anxiety in Canadian men with newly diagnosed localised prostate cancer.MethodsThis is a single-centre prospective cross-sectional study of men with newly diagnosed localized prostate cancer recruited from June 2017 to July 2018. The patient-reported outcomes (PRO) instruments used in this study included the international prostate symptoms score (IPSS), OAB-V8, EQ-5D™, and the Expanded Prostate Cancer Index Composite short form (EPIC-26). Clinico-pathological data were extracted from medical records. The prevalence of LUTS, OAB, sexual dysfunction, depression and anxiety were determined from the PROs.ResultsA total of 83 patients were included in this study. The median age was 63. Based on IPSS scores, 55.3% of men had mild LUTS, 36.8% had moderate LUTS and 7.9% had severe LUTS. Based on OAB-V8 scores, 55.8% of men had a score of 8 or higher, suggestive of OAB. Only 55.8% of men reported erections adequate for intercourse. 23.1% of men reported to have a moderate to big problem with depression, and 28.8% of men reported to have a degree of anxiety or depression.ConclusionsOAB is a significant problem in men with newly diagnosed localized prostate cancer, with a prevalence of 55.8% based on this study. Baseline sexual dysfunction, anxiety and depression are also prevalent in this population.

Decision regret in men living with and beyond nonmetastatic prostate cancer in the United Kingdom: A population-based patient-reported outcome study.

ObjectiveClinical options for managing nonmetastatic prostate cancer (PCa) vary. Each option has side effects associated with it, leading to difficulty in decision‐making. This study aimed to assess the relationship between patient involvement in treatment decision‐making and subsequent decision regret (DR), and quantify the impact of health‐related quality of life (HRQL) outcomes on DR.MethodsMen living in the United Kingdom, 18 to 42 months after diagnosis of PCa, were identified from cancer registration data and sent a questionnaire. Measures included the Decision Regret Scale (DRS), Expanded Prostate cancer Index Composite short form (EPIC‐26), EQ‐5D‐5L, and an item on involvement in treatment decision‐making. Multivariable ordinal regression was utilized, with DR categorized as none, mild, or moderate/severe regret.ResultsA total of 17 193 men with stage I‐III PCa completed the DRS: 36.6% reported no regret, 43.3% mild regret, and 20.0% moderate/severe regret. The odds of reporting DR were greater if men indicated their views were not taken into account odds ratio ([OR] = 6.42, 95% CI: 5.39‐7.64) or were involved “to some extent” in decision‐making (OR = 4.63, 95% CI: 4.27‐5.02), compared with men who were “definitely” involved. After adjustment, including for involvement, men reporting moderate/big problems with urinary, bowel, or sexual function were more likely to experience regret compared with men with no/small problems. Better HRQL scores were associated with lower levels of DR.ConclusionsThis large‐scale study demonstrates the benefit of patient involvement in treatment decision‐making for nonmetastatic PCa. However, men experiencing side effects and poorer HRQL report greater DR. Promoting engagement in clinical decision‐making represents good practice and may reduce the risk of subsequent regret.

Robot-assisted orthotopic "W" ileal neobladder in male patients: step-by-step video-illustrated technique and preliminary outcomes.

The objectivewasto describe our step-by-step technique for robot-assisted orthotopic "W" ileal neobladder (INB) for urinary diversion following radical cystectomy for oncological purpose, and to report the outcomes of this technique for the first six malepatients treated at our center. Patients underwent robot-assisted radical cystoprostatectomy for bladder cancer and had a "W" ileal neaobladder as urinary diversion. Our surgical technique is described step by step and video illustrated. Patients and operative data were collected and reported. The Expanded Prostate Cancer Index Composite Short Form (EPIC-26) self-administered questionnaire was used to assess the urinary, sexual and bowel functions outcomes at 90days postoperatively. The mean operative time was 475min [420-525] and mean length of stay was 13days [11-15]. No major complications occurred (Clavien grade ≥ 3). Regarding the continence four patients reported they leaked urine rarely or never and two patients having urine leak once a day. Two patients did not wear any pad, the four others reported using pad at night. Two patients reported urinary function as not a problem, one as a very small problem, two as a small problem and one as a moderate problem. These results from our six first cases using the technique described here are promising with interesting early functional outcomes. This has to be confirmed on larger cohort and with long-term follow-up.

SBRT as Monotherapy or Boost for Intermediate or High-Risk Prostate Cancer: A Prospective Observational Study

The high level of precision and accuracy of Stereotactic Body Radiotherapy (SBRT,) in addition to its unique radiobiologic characteristics, confer a potential therapeutic advantage with limited toxicity when compared with alternated radiation therapy treatment approaches. Stereotactic Body Radiation Therapy (SBRT) has become a standard treatment alternative to other treatment options such as laparoscopic-assisted robotic prostatectomy, intensity-modulated radiation therapy (IMRT) and brachytherapy in the management of low-risk prostate cancer. The efficacy and risk profile of SBRT in the setting of intermediate and high-risk prostate cancer are less well studied. The purpose of this project is to evaluate the efficacy and Health-Related Quality of Life (HRQOL) in intermediate and high-risk prostate cancer patients treated with SBRT as monotherapy or as a boost in combination with IMRT. 77 patients with intermediate and high-risk prostate cancer were enrolled in this prospective evaluation Intermediate-risk patients (n=47, 61%)) were treated with SBRT monotherapy, 36.25 Gy in 5 fractions, or with SBRT boost to the prostate, 21 Gy in 3 fractions followed by IMRT directed to the prostate and seminal vesicles, 45 Gy in 25 fractions, per physician discretion. High risk patients (n=30, 39%) were treated with SBRT boost to the prostate, 21 Gy in 3 fractions followed by IMRT directed to the prostate, seminal vesicles and pelvic lymph nodes, 45 Gy in 25 fractions. Androgen deprivation hormonal therapy (ADT) was administered to all patients in the high-risk group and per physician discretion in the intermediate-risk group. Biochemical disease-free survival (bDFS) was calculated per the Phoenix definition. Quality of Life (QOL) was assessed by the American Urological Association (AUA) symptom index, Expanded Prostate cancer Index Composite Short Form (EPIC-26), and the Sexual Health Inventory for Men (SHIM). Acute and late genitourinary (GU) and gastrointestinal (GI) toxicity were graded using the CTCAE version 3.0 and RTOG/ECOG definitions. QOL was estimated using least square means of fixed effects. The median follow-up time was 18 months. The bDFS was 96.43%, 100% and 92.59% for favorable-intermediate, unfavorable-intermediate, and high-risk groups, respectively. Late Grade 2 and 3 genitourinary toxicities were 24%, and 1.2 %, and late grade 2 gastrointestinal toxicities were 3% without grade 3 toxicities reported. Mean EPIC QOL scores declined modestly at 1-month post-treatment, plateaued until about 24 months, and recovering to levels close to baseline thereafter. SBRT as monotherapy or boost in the management of intermediate or high-risk patients with adenocarcinoma of prostate is a promising treatment approach, with excellent short-term bDFS and limited late toxicity. These outcomes will continue to be followed with the goals of confirming equivalence or superiority to alternative radiation therapy treatment approaches.

Quality of life in men living with advanced and localised prostate cancer in the UK: a population-based study.

Little is known about the health-related quality of life (HRQOL) of men living with advanced prostate cancer. We report population-wide functional outcomes and HRQOL in men with all stages of prostate cancer and identify implications for health-care delivery. For this population-based study, men in the UK living 18-42 months after diagnosis of prostate cancer were identified through cancer registration data. A postal survey was administered, which contained validated measures to assess functional outcomes (urinary incontinence, urinary irritation and obstruction, bowel, sexual, and vitality and hormonal function), measured with the Expanded Prostate Cancer Index Composite short form (EPIC-26), plus questions about use of interventions for sexual dysfunction) and generic HRQOL (assessed with the 5-level EuroQol five dimensions questionnaire [EQ-5D-5L] measuring mobility, self-care, usual activities, pain or discomfort, and anxiety or depression, plus a rating of self-assessed health). Log-linear and binary logistic regression models were used to compare functional outcomes and HRQOL across diagnostic stages and self-reported treatment groups. Each model included adjustment for age, socioeconomic deprivation, and number of other long-term conditions. 35 823 (60·8%) of 58 930 men responded to the survey. Disease stage was known for 30 733 (85·8%) of 35 823 men; 19 599 (63·8%) had stage I or II, 7209 (23·4%) stage III, and 3925 (12·8%) stage IV disease. Mean adjusted EPIC-26 domain scores were high, indicating good function, except for sexual function, for which scores were much lower. Compared with men who did not receive androgen deprivation therapy, more men who received the therapy reported moderate to big problems with hot flushes (30·7% [95% CI 29·8-31·6] vs 5·4% [5·0-5·8]), low energy (29·4% [95% CI 28·6-30·3] vs 14·7% [14·2-15·3]), and weight gain (22·5%, 21·7-23·3) vs 6·9% [6·5-7·3]). Poor sexual function was common (81·0%; 95% CI 80·6-81·5), regardless of stage, and more than half of men (n=18 782 [55·8%]) were not offered any intervention to help with this condition. Overall, self-assessed health was similar in men with stage I-III disease, and although slightly reduced in those with stage IV cancer, 23·5% of men with metastatic disease reported no problems on any EQ-5D dimension. Men diagnosed with advanced disease do not report substantially different HRQOL outcomes to those diagnosed with localised disease, although considerable problems with hormonal function and fatigue are reported in men treated with androgen deprivation therapy. Sexual dysfunction is common and most men are not offered helpful intervention or support. Service improvements around sexual rehabilitation and measures to reduce the effects of androgen deprivation therapy are required. The Movember Foundation, in partnership with Prostate Cancer UK.

Development and Validation of Crosswalks for Patient-reported Sexual and Urinary Outcomes Between Commonly Used Instruments

BackgroundPatient-reported outcome measures (PROMs) have become widely adopted in the care of patients with prostate cancer, but there is no validated crosswalk between two commonly used instruments, the Expanded Prostate Cancer Index Composite Short Form (EPIC-26) and the Memorial Sloan Kettering (MSK) instrument, which consists of the International Index of Erectile Function-6 (IIEF-6) questionnaire and the MSK radical prostatectomy urinary outcome scale. ObjectiveTo develop and validate bidirectional crosswalks between the sexual and urinary domains (single domain in MSK, separate incontinence and irritative/obstructive domains in EPIC-26) of the MSK and EPIC-26 instruments. Design, setting, and participantsRadical prostatectomy (RP) patients completing instruments at MSK and Michigan Urological Surgery Improvement Collaborative (MUSIC) between January and May of 2017 were invited to enroll. Stratified random sampling (by institution, MSK urinary function score, and MSK erectile function score) was used to divide patient data into training and test sets. Models were developed to predict the domain score for each instrument using the other's item responses and domain scores. Performance was evaluated using capped root-mean-squared error and accuracy at established thresholds. Results and limitationsWe received 517 instruments at MSK and 1033 within MUSIC, which were assigned to training (825), post-RP test (412), and pre-RP test (313) sets. We found the crosswalks to have low error and high accuracy. Although the crosswalks are more accurate if responses to each item are known, it is possible to convert between instruments on the basis of a total domain score. ConclusionsThe crosswalks are a valid way to convert between sexual and urinary domains of the MSK and EPIC-26 instruments. Patient summaryWe developed and validated a set of formulas that allow conversion of sexual and urinary function scores between the Memorial Sloan Kettering and Expanded Prostate Cancer Index Composite Short Form patient-reported outcome questionnaires. These crosswalks allow seamless transition between the two questionnaires.

Impact of Prostate Gland Size ≥60 cc on Physician and Patient-Reported Toxicity after High Dose Rate Prostate Brachytherapy

Prostate volume of ≥60 cubic centimeters (cc) has been a relative contraindication to treatment with interstitial prostate brachytherapy (BT), with some studies showing associations between large prostate size and increased acute toxicity. These studies primarily used low dose rate BT. Few studies have explored toxicity in men with large glands undergoing high dose rate (HDR) BT. We compared the acute patient and physician reported toxicity between men undergoing HDR BT with gland size <60 cc and those with gland size ≥60 cc. We performed a retrospective cohort study of men undergoing prostate HDR BT as part of a prospectively maintained database. The 13.5 Gy x 2 was used for monotherapy and 13.5-15 Gy x 1 for boost to supplement EBRT. Gland size was determined using pre-treatment MRI or TRUS. The International Prostate Symptom Score (IPSS) and Expanded Prostate Cancer Index Composite Short Form (EPIC-26) were used to assess urinary, bowel, and sexual function at baseline and in follow-up. The Common Terminology Criteria for Adverse Events (CTCAE) v4.0 criteria were used to assess genitourinary (GU) and gastrointestinal (GI) toxicity. Baseline demographic and clinical characteristic data were compared between men with gland size <60 cc and those with gland size ≥60 cc using Fisher’s exact and non-parametric Wilcoxon Rank Sum tests. Patient-reported toxicities were compared using Generalized estimating equations (GEE) with an independent weight matrix to account for the correlation between multiple observations. Physician reported toxicities were assessed using a generalized linear mixed effects model. One hundred nineteen men were included in this analysis. Median follow-up was 7.6 months. Median prostate size was 36 cc (range: 13.9-91.9 cc). Thirteen men (10.9%) had a gland size ≥60 cc. There were no differences in baseline urinary medication use, baseline IPSS, or baseline EPIC-26 domain scores between the two groups. There were no differences in mean IPSS over time between the two groups (p=0.9). Men with gland size ≥60 cc had a greater decline in the EPIC-26 urinary incontinence domain score at 1 month (p<0.01) that met criteria for minimal clinically important difference (MCID), but no difference at 3 or 6 months. Men with gland size ≥60 cc had higher urinary irritative/obstructive domain scores at 3 months (p=0.03) that met criteria for MCID, but no difference at 1 or 6 months. There was no difference between groups in bowel or sexual domains. There was a trend towards higher acute urinary retention (AUR) in the ≥ 60 cc group (p=0.06). There was no difference in grade ≥2 GU toxicity and grade ≥2 GI toxicity. Men with prostate gland size of ≥60 cc have no difference in acute physician-reported toxicity, but a trend towards worse AUR and worse urinary incontinence at one month, yet better urinary irritative/obstructive scores at 3 months. Further investigation is needed to limit the impact of therapy on urinary function in men with gland size ≥60 cc.

Mediterranean diet after prostate cancer diagnosis and urinary and sexual functioning: The health professionals follow-up study.

Men with prostate cancer often experience urinary and sexual dysfunction after treatment. Previous studies have demonstrated a relationship between dietary factors and these symptoms among men with diabetes or metabolic syndrome. However, there are limited data on whether diet after prostate cancer diagnosis, including a Mediterranean dietary pattern, affects urinary and sexual function among prostate cancer survivors. Men diagnosed with non-metastatic prostate cancer in the Health Professionals Follow-up Study (n = 2960) from 1986 to 2012 were prospectively followed for a median of 8.3 years after treatment. Participants completed validated dietary questionnaires every 4 years and a health-related quality of life assessment in 2010 or 2012. We used generalized linear models to examine associations between post-diagnosis Mediterranean Diet Score (including individual score components and dietary fat subtypes) and quality of life domains (sexual functioning, urinary irritation/obstruction, urinary incontinence) assessed using the Expanded Prostate Cancer Index Composite Short Form (score 0-100; higher scores indicate better function). No statistically significant relationships were observed between the Mediterranean Diet Score after prostate cancer diagnosis and urinary or sexual function. However, the associations did vary depending on pre-diagnosis urinary and sexual dysfunction for urinary irritation/obstruction and sexual function scores, respectively (P-interactions < 0.0001). Men with higher post-diagnosis vegetable intake reported higher urinary incontinence scores (72 vs 76 comparing lowest to highest quintile; P-trend = 0.003). Similarly, higher vegetable intake and lower polyunsaturated fat intake were associated with higher urinary irritation/obstruction scores (vegetable: 80 vs 84 comparing lowest to highest quintile, P-trend = 0.01; polyunsaturated fat: 84 vs 78 comparing lowest to highest quintile, P-trend = 0.005), however these associations were observed only among men with urinary symptoms prior to their prostate cancer diagnosis. Among men with prostate cancer, diet intake after diagnosis was not significantly associated with urinary or sexual function, although some relationships appeared to differ among men with and without symptoms prior to their prostate cancer diagnosis. Higher vegetable intake and lower polyunsaturated fat intake after prostate cancer diagnosis may be associated with better urinary function. However, this analysis was exploratory, and further research is needed to better delineate these relationships and guide dietary recommendations for men with prostate cancer.

Quality of Life, Psychological Functioning, and Treatment Satisfaction of Men Who Have Undergone Penile Prosthesis Surgery Following Robot-Assisted Radical Prostatectomy

BackgroundPenile prosthesis surgery is last-line treatment to regaining erectile function after radical prostatectomy (RP) for localized prostate cancer. AimsTo assess quality of life, psychological functioning, and treatment satisfaction of men who underwent penile implantation after RP; the psychosocial correlates of treatment satisfaction and sexual function after surgery; and the relation between patients’ and partners’ ratings of treatment satisfaction. Methods98 consecutive patients who underwent penile implantation after RP from 2010 and 2015 and their partners were invited to complete a series of measures at a single time point. Of these, 71 patients and 43 partners completed measures assessing sexual function, psychological functioning, and treatment satisfaction. Proportions of patients who demonstrated good sexual function and satisfaction with treatment and clinical levels of anxiety and depression were calculated. Hierarchical regression analyses were conducted to determine psychosocial factors associated with patient treatment satisfaction and sexual function and patient-partner differences in treatment satisfaction. OutcomesPatients completed the Expanded Prostate Cancer Index Composite Short Form (EPIC-26), Erectile Dysfunction Inventory of Treatment Satisfaction (EDITS), Prostate Cancer-Related Quality of Life Scale, Self-Esteem and Relationship Questionnaire (SEAR), Generalized Anxiety Disorder–7 (GAD-7), and Patient Health Questionnaire–9 (PHQ-9). Partners completed the GAD-7, PHQ-9, EDITS (partner version), and SEAR. Results94% of men reported satisfaction with treatment (EDITS score > 50). 77% of men reported good sexual function (EPIC-26 score > 60). Lower depression scores were associated with higher sexual confidence and sexual intimacy, and these were correlated with better treatment satisfaction and sexual function. Patients experienced higher sexual relationship satisfaction (median score = 90.6) than their partners (median score = 81.2), but there was no difference in treatment satisfaction between groups. Higher patient treatment satisfaction was more likely to be reported for couples whose depression scores were more similar. Clinical ImplicationsIt is important to provide preoperative penile implant counseling and encourage patients to seek postoperative counseling if needed. Strengths and LimitationsThis is one of the first Australian-based studies comprehensively assessing treatment satisfaction and psychosocial health of men after penile prosthesis surgery after RP. This was a retrospective cross-sectional study, so there is a possibility of recall bias, and causal associations could not be determined. ConclusionMen in this Australian series who underwent penile prosthesis surgery after RP generally reported good sexual function and treatment satisfaction. Nevertheless, patient and partner mental health influenced their reported experience of the treatment.Pillay B, Moon D, Love C, et al. Quality of Life, Psychological Functioning, and Treatment Satisfaction of Men Who Have Undergone Penile Prosthesis Surgery Following Robot-Assisted Radical Prostatectomy. J Sex Med 2017;14:1612–1620.

Toxicity and quality of life report of a phase II study of stereotactic body radiotherapy (SBRT) for low and intermediate risk prostate cancer

BackgroundClinical data indicates that delivery of larger daily doses of radiation may improve the therapeutic ratio for prostate cancer compared to conventional fractionation. A phase II study of stereotactic body radiotherapy with real-time motion management and daily plan re-optimization for low to intermediate risk prostate cancer was undertaken to evaluate this hypothesis. This report details the toxicity and quality of life following treatment.MethodsFrom 2009 to 2013, 60 patients with T1–T2c prostate cancer with a Gleason score of 6 and PSA ≤ 15 or Gleason score of 7 and PSA ≤ 10 were enrolled. Patients with nodal metastases, an American Urological Association symptom score > 18, or gland size > 100 g were not eligible. Patients were treated to 37 Gy in 5 fractions. Early and late genitourinary and gastrointestinal toxicity were graded based on NCI CTCAE v4.0 and quality of life was assessed by the American Urological Association symptom score, International Index of Erectile Function, and Expanded Prostate cancer Index Composite Short Form up to 36 months after treatment.ResultsAfter a median follow-up of 27.6 months, no grade 3 or greater genitourinary toxicity was observed. Four patients (6.7%) reported a late grade 2 genitourinary toxicity. One patient (1.7%) reported a late grade 3 gastrointestinal toxicity. Five patients (8.3%) developed a late grade 2 gastrointestinal toxicity. The median American Urological Association symptom score increased from 4.5 prior to treatment to 11 while on treatment (p < 0.01), but was 5 at 36 months post-treatment (p = 0.65). Median International Index of Erectile Function scores decreased from 19 to 17 over the course of follow-up (p < 0.01). Only median scores within the Expanded Prostate Cancer Index Composite Short Form sexual domain were significantly decreased at 36 months post-treatment (67.9 vs 45.2, p = 0.02). There was no significant difference in median score within the urinary, bowel, or hormonal domains at 36 months of follow-up.ConclusionsStereotactic body radiotherapy for low to intermediate risk prostate cancer is well tolerated with limited toxicity or decrease in quality of life. Longer follow-up is necessary to assess the efficacy of treatment.Trial registrationClinicaltrials.gov NCT00941915 Registered 17 June 2009.

Patient-Reported Outcome After Prostate Stereotactic Body Radiation Therapy—An Analysis of Dosimetric Correlation of Minimally Import Difference for the Expanded Prostate Cancer Index Composite Short Form (EIPIC-26)

Patient-Reported Outcome After Prostate Stereotactic Body Radiation Therapy—An Analysis of Dosimetric Correlation of Minimally Import Difference for the Expanded Prostate Cancer Index Composite Short Form (EIPIC-26)

Erratum to: A phase II experience evaluating quality of life and survival in linac-based SBRT for prostate cancer

This study aims to evaluate SBRT with volumetric modulated arc therapy (VMAT) and toxicity using five validated quality of life (QOL) instruments. An approved prospective NCI-designated phase II study (NCT01581749) was conducted. The inclusion criteria are the following: histologically proven prostate adenocarcinoma, Gleason score 6–7, clinical stage T1b-T2b, PSA ≤20 ng/ml, prostate volume ≤100 cm3, and no prior prostate radiotherapy. SBRT was delivered as 36.25 Gy in five fractions to PTV via VMAT. Patients self-reported on validated QOL measures including the American Urological Association (AUA) Index, Sexual Health Inventory for Men (SHIM), Utilization of Sexual Medications/Devices (USMD), and Expanded Prostate Cancer Index Composite Short Form (EPIC-26). In addition, PSA response and survival were evaluated. A total of 33 patients were entered into the study. Median time from treatment to last follow up was 30 months. Mean age was 67.5 years. Mean PSA was 6.1 and Gleason scores ranged from 6 to 7. Mean PSA declined by 42 % was observed at 1 month post-treatment and continued to decrease. Three patients (9.7 %) had PSA bounce, with one patient having disease progression (3.0 %). There were no transient side effects or sequelae noted on their QOL questionnaires over the follow-up period of 36 months. Some adverse effects to sexual health were noticed with the majority of these incidences occurring within 1 month after treatment and resolved within 3 months of symptom onset. SBRT with VMAT for low-intermediate risk prostate cancer is well tolerated. Acute toxicities showed no apparent impact on patient general sense of well-being. No adverse effects were observed over the 36 month period.

MP80-09 IS EXTRAPERITONEAL ROBOT-ASSISTED RADICAL PROSTATECTOMY CONTRAINDICATED IN THE SETTING OF PRIOR INGUINAL HERNIA REPAIR WITH MESH?

INTRODUCTION AND OBJECTIVES: Urinary incontinence post radical prostatectomy is a common complication regardless of approach, with significant negative impact on health-related quality of life. Although 12-month continence rates range from 85-95% in established studies, few patients are continent in the early postoperative period. The posterior reconstruction of Denonvilliers’ musculofascial plate (PRDMP) may improve the early return to urinary continence, though reports in the literature have been mixed, warranting further study. Weaknesses in previous studies of PRDMP included varied definitions of continence, differing surgeon experience, lack of randomization, and insufficient statistical power. We compared the PRDMP versus standard urethrovesical anastomosis during robotassisted radical prostatectomy (RARP) in a randomized controlled trial (RCT). METHODS: Patients with clinically localized prostate cancer scheduled for RARP were prospectively recruited in clinic and randomly allocated to PRDMP or conventional anastomosis. Patients were blinded to allocation status and the surgeon was informed immediately before the case to minimize bias. All cases were performed by a highvolume surgeon at a tertiary healthcare center. Our primary outcome was assessed by using the Expanded Prostate Cancer Index Composite Short Form (EPIC-26) survey at baseline and 2, 3, 4, 6, 8, and 12-months postoperatively. Continence was defined as an answer of 0-1 safety pad per day. The trial is powered to detect a significant improvement in continence of 40-75% at 3 months with an a level of 0.05 at 80%, requiring 65 patients per group for power. We have oversampled to account for attrition. Follow-up interviews were done via telephone. RESULTS: Recruitment occurred from April 2014 to July 2015, with a total N1⁄4164. We currently have 6-month follow-up data available on 55 patients in the PRDMP group and 42 in the control group. At months 2, 3, 4, and 6, use of pads for the intervention group and the control group at 0-1 per day (measured continence) was 36.5% and 37.5%, 60.7% and 60.5%, 72.6% and 65.7%, and 83% and 76.5%, respectively CONCLUSIONS: Interim analysis of this RCT suggests a trend toward the PRPMD being more effective than conventional anastomosis in terms of early return to continence following RARP, but more so as the data reached the fourth month. The two groups were also not equal in size. Final analysis at the completion of this RCT is required to establish statistical significance of these findings.