Patient-reported Outcomes In Men Research Articles

Does cost minimization of hypofractionated radiation therapy content all health stakeholders?

Does cost minimization of hypofractionated radiation therapy content all health stakeholders?

(487) Long-term Outcomes Following Partial Plaque Excision and Grafting (PEG) for Peyronie’s Disease and Subanalysis of Patients Who Undergo PEG Despite Pre-operative Counseling Against PEG

Abstract Introduction Peyronie’s Disease (PD) is a debilitating condition characterized by progressive scarring of the tunica albuginea. The resulting deformities are often emotionally devastating to patients, and include erectile dysfunction, painful erections, penile curvature, indentation, hourglass, and hinge deformities. According to previously published surgical algorithm for PD in 1997, partial plaque excision and grafting (PEG) is recommended for patients with >60 degree curvature +/− hinge and strong pre-operative erections while placement of an inflatable penile prosthesis (IPP) is recommended when rigidity is sub-optimal.* Nevertheless, many patients counseled to undergo an IPP refuse and insist on proceeding with PEG due to personal preference. We hypothesize that men counseled to undergo IPP but choose to undergo PEG will report lower satisfaction rates and reduced ability to engage in sexual intercourse post-operatively. Objective Our objective was to evaluate and compare long-term patient-reported outcomes in men who underwent PEG at a single institution between 2007 and 2021. Methods A retrospective chart review was conducted from 2007 to 2021 on PEG surgeries performed at a single, tertiary-care institution in patients ≥18 years old who had >3 months of follow up. Results 251 patients underwent PEG with a mean follow up was 35.5 months. 54 patients (22%) were initially advised to undergo IPP but elected for PEG. Of these 54 patients, 17 (32%) had pre-operative 9-10 subjective erectile rigidity, relative to 110 of 197 (56%) patients who were initially counseled to undergo PEG (p=0.002). On duplex penile ultrasound, patients counseled to undergo IPP had a mean objective erectile rigidity of 7.8, compared to a mean objective rigidity of 8.6 in patients initially counseled to undergo PEG (p 15 units for pre-operative duplex ultrasound evaluation were less likely to be able to engage in post-operative intercourse following PEG surgery (48.6%) relative to those who needed <15 units (71.1%) (p=0.02). Conclusions Patients who were initially counseled to undergo IPP due to sub-optimal erectile rigidity but elected for PEG procedure had worse post-operative ability to engage in penetrative intercourse. Significantly more of these patients also eventually underwent IPP. Pre-operative trimix dosing <15U is a predictor of post-operative erectile function as it may be reflective of better pre-operative erectile quality. Subjective and objective measures of erectile function appear to be critical predictors of post-operative erectile function in patients who had underwent PEG, confirming the previously published 1997 algorithm on the surgical management of PD.* *J Urol 1997; 158: 2149-52. Disclosure Any of the authors act as a consultant, employee or shareholder of an industry for: Boston Scientific (Consultant)

Patient-reported Outcomes in Men with Metastatic Castration-resistant Prostate Cancer Harboring DNA Damage Response Alterations Treated with Talazoparib: Results from TALAPRO-1

BackgroundTalazoparib has shown antitumor activity with a manageable safety profile in men with metastatic castration-resistant prostate cancer (mCRPC) and DNA damage response (DDR)/homologous recombination repair (HRR) alterations. ObjectiveTo evaluate patient-reported health-related quality of life (HRQoL) and pain in patients who received talazoparib in the TALAPRO-1 study, with a special interest in patients harboring breast cancer susceptibility gene 1 or 2 (BRCA1/2) mutations. Design, setting, and participantsTALAPRO-1 is a single-arm, phase 2 study in men with mCRPC DDR alterations either directly or indirectly involved in HRR, who previously received one to two taxane-based chemotherapy regimens for advanced prostate cancer and whose mCRPC progressed on one or more novel hormonal agents. Outcome measurements and statistical analysisMen completed the European Quality-of-life Five-dimension Five-level scale (EQ-5D-5L), EQ-5D visual analog scale (VAS), and Brief Pain Inventory—Short Form at predefined time points during the study. The patient-reported outcome (PRO) population included men who completed a baseline and one or more postbaseline assessments before study end. Longitudinal mixed-effect models assuming an unstructured covariance matrix were used to estimate the mean (95% confidence interval [CI]) change from baseline for pain and general health status measurements among all patients and patients with BRCA1/2 mutations. Results and limitationsIn the 97 men in the PRO population treated with talazoparib (BRCA1/2, n = 56), the mean (95% CI) EQ-5D-5L Index improved (all patients, 0.05 [0.01, 0.08]; BRCA1/2 subset, 0.07 [0.03, 0.10]), as did the EQ-5D VAS scores (all patients, 5.42 [2.65, 8.18]; BRCA1/2 subset, 4.74 [1.07, 8.41]). Improvements in the estimated overall change from baseline (95% CI) in the mean worst pain were observed in all patients (–1.08 [–1.52, –0.65]) and the BRCA1/2 subset (–1.15 [–1.67, –0.62]). The probability of not having had experienced deterioration of worst pain by month 12 was 84% for all patients and 83% for the BRCA1/2 subset. ConclusionsIn heavily pretreated men with mCRPC and DDR/HRR alterations, talazoparib was associated with improved HRQoL in all patients and the BRCA1/2 subset. In both patient groups, worst pain improved from baseline and the probability of not experiencing a deterioration in worst pain with talazoparib was high. Patient summaryWe show that talazoparib was associated at least with no change or improvements in health-related quality of life (HRQoL) and pain burden in men with metastatic castration-resistant prostate cancer and DNA damage response/homologous recombination repair gene alterations in the TALAPRO-1 study. These findings in patient-reported HRQoL and pain complement the antitumor activity and tolerability profile of talazoparib.

Evaluation of Hypofractionated Radiation Therapy Use and Patient-Reported Outcomes in Men With Nonmetastatic Prostate Cancer in Australia and New Zealand

Randomized clinical trials in prostate cancer have reported noninferior outcomes for hypofractionated radiation therapy (HRT) compared with conventional RT (CRT); however, uptake of HRT across jurisdictions is variable. To evaluate the use of HRT vs CRT in men with nonmetastatic prostate cancer and compare patient-reported outcomes (PROs) at a population level. Registry-based cohort study from the Australian and New Zealand Prostate Cancer Outcomes Registry (PCOR-ANZ). Participants were men with nonmetastatic prostate cancer treated with primary RT (excluding brachytherapy) from January 2016 to December 2019. Data were analyzed in March 2021. HRT defined as 2.5 to 3.3 Gy and CRT defined as 1.7 to 2.3 Gy per fraction. Temporal trends and institutional, clinicopathological, and sociodemographic factors associated with use of HRT were analyzed. PROs were assessed 12 months following RT using the Expanded Prostate Cancer Index Composite (EPIC)-26 Short Form questionnaire. Differences in PROs were analyzed by adjusting for age and National Comprehensive Cancer Network risk category. Of 8305 men identified as receiving primary RT, 6368 met the inclusion criteria for CRT (n = 4482) and HRT (n = 1886). The median age was 73.1 years (IQR, 68.2-77.3 years), 2.6% (168) had low risk, 45.7% (2911) had intermediate risk, 44.5% (2836) had high-/very high-risk, and 7.1% (453) had regional nodal disease. Use of HRT increased from 2.1% (9 of 435) in the first half of 2016 to 52.7% (539 of 1023) in the second half of 2019, with lower uptake in the high-/very high-risk (1.9% [4 of 215] to 42.4% [181 of 427]) compared with the intermediate-risk group (2.2% [4 of 185] to 67.6% [325 of 481]) (odds ratio, 0.26; 95% CI, 0.15-0.45). Substantial variability in the use of HRT for intermediate-risk disease remained at the institutional level (median 53.3%; range, 0%-100%) and clinician level (median 57.9%; range, 0%-100%) in the last 2 years of the study period. There were no clinically significant differences across EPIC-26 urinary and bowel functional domains or bother scores. In this cohort study, use of HRT for prostate cancer increased substantially from 2016. This population-level data demonstrated clinically equivalent PROs and supports the continued implementation of HRT into routine practice. The wide variation in practice observed at the jurisdictional, institutional, and clinician level provides stakeholders with information that may be useful in targeting implementation strategies and benchmarking services.

Long-term patient-reported outcomes in men with Peyronie's disease undergoing nonsurgical and nonintralesional injection management.

Peyronie's disease (PD) has a negative impact on overall quality of life for many patients and their partners. There is a significant portion of patients who elect noninvasive therapy and in this scenario we have little data with which to counsel patients. We aim to evaluate long-term patient-reported outcomes in a cohort of men with PD who elected conservative treatment. We identified all males with a diagnosis of PD evaluated at our institution by a single provider between May 2012 and January 2018. We excluded men who were <18 years old or had undergone surgical or intralesional injection (ILI) treatments. A PD-specific questionnaire was sent to those who met our inclusion criteria. 88/514 patients completed the survey and met the inclusion criteria. Penile curvature subjectively improved in 49%, remained stable in 34%, and worsened in 17%. Penile shortening was reported in 89% of patients. Penile shortening subjectively improved in 27%, remained stable in 59%, and worsened in 14%. Roughly 60% reported worsened intercourse satisfaction and erectile function. 60% reported that PD had negatively impacted their self-esteem and 69% felt that PD negatively impacted their sexual partner. Patients who utilized penile traction therapy (PTT) were significantly more likely to report improvements in penile curvature, shortening, and ability to engage in penetrative intercourse. Our survey provides important data on patient-reported outcomes in men with PD electing nonsurgical and non-ILI interventions. Although 49% of men noted at least a mild subjective improvement in their curvature over time, a majority had declining erectile function, decreased intercourse satisfaction, and psychosocial distress. These data can be used when counseling patients with a new diagnosis of PD who are considering treatment options.

Significantly increased risk of all-cause mortality among cardiac patients feeling lonely

ObjectiveTo explore whether living alone and loneliness 1) are associated with poor patient-reported outcomes at hospital discharge and 2) predict cardiac events and mortality 1 year after hospital discharge in...

The Oxytocin Antagonist Cligosiban Prolongs Intravaginal Ejaculatory Latency and Improves Patient-Reported Outcomes in Men with Lifelong Premature Ejaculation: Results of a Randomized, Double-Blind, Placebo-Controlled Proof-of-Concept Trial (PEPIX)

IntroductionCligosiban is an orally administered oxytocin receptor antagonist being developed to treat premature ejaculation (PE). AimTo determine the safety and efficacy of cligosiban capsules (dose range 400–800 mg) to improve intravaginal ejaculation latency time (IELT) and patient-reported outcomes in men with severe lifelong PE. MethodsPatients recorded details of at least 4 sexual intercourse events during a 4-week run-in period, after which they underwent baseline assessments. Patients were eligible for the study if they rated their control of ejaculation as poor/very poor and their stopwatch-assessed IELT was ≤1 minute in ≥75% of intercourse attempts. Eligible patients were randomized to an 8-week treatment period with double-blind cligosiban or placebo (to be taken 1 to 6 hours prior to sexual activity). The starting dose was 400 mg (not more than 1 dose per day) which could be increased to 800 mg after 2 and/or 4 weeks of treatment. Assessments were conducted at 2, 4, and 8 weeks. Main Outcome MeasureEfficacy measures were comprised of IELT, self-rating of ejaculation control and ejaculation-related distress (recorded in an electronic diary after each intercourse attempt), premature ejaculation profile, and the Clinical Global Impression of Change. ResultsThe mean ratio of fold change from baseline in IELT to the last 4 weeks of treatment (cligosiban/placebo) was 1.9 compared to a baseline of 1.0 (P = .0079). The mean increase in IELT from baseline to the last 4 weeks of treatment was 61.0 seconds for cligosiban, which was significantly different from (and 3.6-fold greater than) the mean increase of 16.4 seconds for placebo (P = .0086). Statistically significant improvements in ejaculation control and ejaculation-related personal distress scores were also observed for cligosiban compared to little or no change with placebo. Cligosiban was generally well tolerated, with no serious or severe adverse events or other safety parameters. Clinical ImplicationsThis proof-of-concept study demonstrated the potential for cligosiban, an oxytocin antagonist, to successfully treat symptoms of severe lifelong PE. Strengths and LimitationsThis was a Phase II, randomized, double-blind, placebo-controlled study that was adequately powered to detect a clinically meaningful difference in change in IELT between cligosiban and placebo. Larger studies will be needed to confirm these findings, determine the optimal dose of cligosiban and assess efficacy in men with acquired PE. ConclusionsCligosiban was well tolerated, and resulted in significant benefits in both objective and subjective measures of ejaculatory control in men with lifelong PE and therefore offers significant potential as an on-demand, orally administered agent for the treatment of PE.McMahon C, Althof S, Rosen R, et al. The Oxytocin Antagonist Cligosiban Prolongs Intravaginal Ejaculatory Latency and Improves Patient-Reported Outcomes in Men with Lifelong Premature Ejaculation: Results of a Randomized, Double-Blind, Placebo-Controlled Proof-of-Concept Trial (PEPIX). J Sex Med 2019; 16:1178–1187.

The Oxytocin Antagonist Cligosiban Fails to Prolong Intravaginal Ejaculatory Latency in Men with Lifelong Premature Ejaculation: Results of a Randomized, Double-Blind, Placebo-Controlled Phase IIb trial (PEDRIX)

IntroductionCligosiban is an orally administered, centrally penetrant oxytocin receptor antagonist being developed to treat premature ejaculation (PE). AimTo determine the efficacy of 3 dose levels of cligosiban caplets to prolong intravaginal ejaculation latency time (IELT) and improve patient-reported outcomes in men with lifelong PE. MethodsPatients recorded details of at least 4 sexual intercourse events during a 4-week run-in period, after which they underwent baseline assessments. Patients were eligible for the study if their stopwatch-assessed IELT was ≤1 minute in ≥75% of intercourse attempts and if they met other diagnostic criteria for lifelong PE. Eligible patients (target 220 evaluable) were randomized to double-blind cligosiban 400, 800, or 1200 mg or matching placebo caplets (to be taken 1 to 6 hours prior to sexual activity). Assessments were conducted at 2, 4, and 8 weeks. Main Outcome MeasureEfficacy measures were comprised of IELT, self-rating of ejaculation control and ejaculation-related distress (recorded in an electronic diary after each intercourse attempt), premature ejaculation profile, Patient’s Global Impression of Severity, and the Clinical Global Impression of Change. ResultsThere were no clinically or statistically significant differences between cligosiban (at any dose level) and placebo for the primary endpoint (change in geometric IELT) or any of the secondary endpoints. Cligosiban was well tolerated with a side-effect profile similar to placebo. Clinical ImplicationsThis Phase IIb study failed to demonstrate the potential for cligosiban, an oxytocin antagonist, to successfully treat symptoms of severe lifelong PE at doses up to 1200 mg. Strengths and LimitationsThis was a Phase IIb, randomized, double-blind, placebo-controlled study that was adequately powered but failed to detect a clinically meaningful or statistical difference in change in IELT between cligosiban at 3 dose levels and placebo. This is in contrast to a similarly designed proof-of-concept study where cligosiban was flexibly dosed at doses up to 800 mg and did demonstrate clinically meaningful and statistically significant changes in efficacy parameters. The reasons for this disparity are not known. ConclusionsCligosiban was well tolerated but failed to demonstrate efficacy for the treatment of men with lifelong PE at doses up to 1200 mg.Althof S, Osterloh IH, Muirhead GJ, et al. The Oxytocin Antagonist Cligosiban Fails to Prolong Intravaginal Ejaculatory Latency in Men with Lifelong Premature Ejaculation: Results of a Randomized, Double-Blind, Placebo-Controlled Phase IIb trial (PEDRIX). J Sex Med 2019; 16:1188–1198.

Conservatively Managed Peyronie's Disease—Long-term Survey Results From Patients Undergoing Nonsurgical and Noninjection Therapies

To evaluate patient-reported temporal changes in penile curvature, pain, shortening, sexual function, and quality of life in men undergoing conservative treatment for PD. Of 3840 patients who underwent evaluation at our institution between 1990 and 2012, 719 were randomly selected to receive a mail-in questionnaire with topics including penile curvature, pain, shortening, sexual function, and quality of life. Men endorsing prior intralesional or surgical therapy were excluded. A total of 125 patients completed the survey and met the inclusion criteria. The median duration between onset of PD symptoms and survey completion was 8.4 years. Overall, 38% felt that their condition had overall improved and 26% felt that their condition had worsened since onset. Penile curvature resolved in 43%, remained stable in 37%, and worsened in 20%. Twelve percent of the men developed a second de novo curvature. Penile pain occurred in 42%, among whom the pain worsened in 18% and completely resolved in 64%. Sixty-five percent reported penile shortening. Subjective erectile function decreased in 60%, and >40% experienced difficulties with penetrative intercourse. Sexual frequency decreased in 68% of the patients and 59% reported decreased relationship satisfaction. Approximately 50% described negative psychological impacts on self-esteem and image. The current report provides the most comprehensive and longest-term data on patient-reported outcomes in men undergoing nonsurgical and noninjection therapies. Although approximately 40% of the men reported overall and curvature improvement at a median 8.4-year follow-up, penile length loss, worsening sexual function, relationship dissatisfaction, and psychosocial distress occurred in the majority of PD men.

Pharmacokinetics, Clinical Efficacy, Safety Profile, and Patient-Reported Outcomes in Patients Receiving Subcutaneous Testosterone Pellets 900 mg for Treatment of Symptoms Associated With Androgen Deficiency

BackgroundImplantation of testosterone doses of at least 150 to 450 mg (ie, two to six pellets) is common clinical practice despite a lack of prospective data. AimTo evaluate pharmacokinetics, clinical efficacy, safety, and patient-reported outcomes in men with androgen deficiency who received implantation of testosterone pellets (900 mg) in an open-label study. MethodsMen with androgen deficiency (serum testosterone < 300 ng/dL [10.4 nmol/L]) were screened and received 12 testosterone pellets (900 mg). Serum hormone measurements (total and free testosterone, dihydrotestosterone, and estradiol) were obtained on days 1, 5, 8, 15, 29, 57, 85, and 113. All hormones were assayed using validated liquid chromatography and tandem mass spectrometry. OutcomesPharmacokinetics of selected hormones was determined. The patient-reported International Index of Erectile Function (IIEF), Center for Epidemiologic Studies Depression (CES-D), and Androgen Deficiency in the Aging Male (qADAM) questionnaires also were performed. Patients rated their satisfaction on a scale from 1 (very satisfied) to 5 (very dissatisfied). Adverse events were monitored throughout. ResultsFifteen patients were included (mean age = 54.5 years, SD = 8.6 years). Mean baseline total testosterone concentration was 241.6 ng/dL (SD = 88.8 ng/dL; mean = 8.4 nmol/L, SD = 3.1 nmol/L). Mean testosterone serum concentrations fluctuated during the first 2 weeks (range = 300–1,000 ng/dL, 10.4–34.7 nmol/L) but remained higher than or equal to 300 ng/dL (10.4 nmol/L) through day 113. Concentrations of free testosterone, dihydrotestosterone, and estradiol mirrored that of total testosterone. Male functioning (IIEF score), depression (CES-D total score), and androgen-deficiency symptoms (qADAM total score) improved from baseline. Most patients were “very satisfied” (40.0%) or “quite satisfied” (26.7%) with treatment. Testosterone pellets were well tolerated. Pellet extrusion and polycythemia occurred in one patient each. Clinical ImplicationsImplantation of high doses (900 mg) of testosterone pellets are generally well tolerated and could provide clinical benefit for some patients. Strengths and LimitationsThis study provides standardized data for the implantation of 12 testosterone pellets. However, the open-label uncontrolled design of this study and its small and ethnically non-diverse patient population limit the interpretation of these data, particularly the patient-reported outcomes. ConclusionImplantation of 12 testosterone pellets (900 mg) was well tolerated and provided adequate and sustained serum testosterone concentrations. Additional randomized controlled trials are needed to confirm efficacy and safety findings.McMahon CG, Shusterman N, Cohen B. Pharmacokinetics, Clinical Efficacy, Safety Profile, and Patient-Reported Outcomes in Patients Receiving Subcutaneous Testosterone Pellets 900 mg for Treatment of Symptoms Associated With Androgen Deficiency. J Sex Med 2017;14:883–890.

Impact of symptomatic skeletal events on health-care resource utilization and quality of life among patients with castration-resistant prostate cancer and bone metastases.

Data regarding the impact of symptomatic skeletal events (SSEs) on health economics and patient-reported outcomes in men with castration-resistant prostate cancer (CRPC) and bone metastases from a clinical setting are lacking. Hence, this study aimed to quantify the effects of SSEs on health-care resource utilization (HRU), health-related quality of life (HRQoL) and pain in men with CRPC metastasized to bone. This cohort study included men with CRPC and bone metastasis treated at a tertiary center during December 1996-July 2015. SSEs, including pathological fracture, radiation to bone, spinal cord compression and bone surgery, as well as HRU were identified retrospectively through medical records and clinical database. A subset of surviving patients completed Functional Assessment of Cancer Therapy-Prostate (FACT-P) and Brief Pain Inventory-Short Form (BPI-SF) questionnaires. The incremental effect of SSEs on HRU was evaluated using multivariable generalized linear regression. Questionnaire scores were compared using effect sizes (ES); ES⩾0.33 indicated meaningful differences between SSE and non-SSE cohorts. Lower scores suggest lower HRQoL and pain. Of the 832 patients, 207 developed ⩾1 SSE (mean 1.5±0.8) during follow-up (median 2.1 years). Radiation to bone was the most common SSE (84.1%). SSE cohort had significantly higher emergency room (incidence rate ratio (IRR)=1.48; P=0.006), outpatient (IRR=1.17; P=0.005) and inpatient (IRR=1.74; P<0.001) visits. Of the 107 eligible survey patients, 103 (96.3%) responded. SSE cohort had lower mean FACT-P functional well-being (17.5 vs 19.8; P=0.158; ES=0.36), higher mean pain severity (2.5 vs 1.6; P=0.048; ES=0.47) and worst pain scores (3.6 vs 2.3; P=0.033; ES=0.50) compared with the non-SSE cohort, indicating meaningful differences between cohorts. This study demonstrated high economic and HRQoL burden of SSEs. The findings underscore the need for better supportive and disease-modifying treatments for these patients.

On-demand Modafinil Improves Ejaculation Time and Patient-reported Outcomes in Men With Lifelong Premature Ejaculation

To evaluate the effects of modafinil on the intravaginal ejaculatory latency time (IELT) and patient-reported outcomes in patients with lifelong premature ejaculation (PE). Treatment-naïve lifelong PE patients were included in this proof-of-concept study. Self-estimated IELTs of the patients were recorded and the Premature Ejaculation Profile (PEP) questionnaire was administered before the initiation of on-demand modafinil 100 mg treatment. At the end of 1 month of treatment, self-estimated IELTs were recorded again, along with posttreatment PEP outcomes. Overall, 55 lifelong PE patients with a mean age of 35.07 ± 7.80 (range: 22-58) years were enrolled. Modafinil treatment modestly increased the mean IELT at the end of 1 month (24.82 ± 16.10 seconds vs 49.82 ± 31.46 seconds, P = .0001). Moreover, at the end of 1 month, patients reported in the PEP questionnaire better control over ejaculation (0.75 ± 0.67 vs 1.35 ± 0.91, P = .0001), improved satisfaction with sexual intercourse (0.98 ± 0.78 vs 1.40 ± 0.85, P = .0001), lesser personal distress (0.42 ± 0.69 vs 0.89 ± 1.01, P = .0001), and reduced interpersonal difficulty (1.69 ± 1.48 vs 1.95 ± 1.47, P = .0001). In an uncontrolled proof-of-concept study of men with treatment-naïve lifelong PE where IELT was self-reported without a stopwatch, modest improvements of both IELT and patient-reported outcome measures were observed. Future controlled clinical trials are necessary to confirm these findings.

Transperineal prostate biopsies for diagnosis of prostate cancer are well tolerated: a prospective study using patient-reported outcome measures.

We aimed to determine short-term patient-reported outcomes in men having general anesthetic transperineal (TP) prostate biopsies. A prospective cohort study was performed in men having a diagnostic TP biopsy. This was done using a validated and adapted questionnaire immediately post-biopsy and at follow-up of between 7 and 14 days across three tertiary referral hospitals with a response rate of 51.6%. Immediately after biopsy 43/201 (21.4%) of men felt light-headed, syncopal, or suffered syncope. Fifty-three percent of men felt discomfort after biopsy (with 95% scoring <5 in a 0–10 scale). Twelve out of 196 men (6.1%) felt pain immediately after the procedure. Despite a high incidence of symptoms (e.g., up to 75% had some hematuria, 47% suffered some pain), it was not a moderate or serious problem for most, apart from hemoejaculate which 31 men suffered. Eleven men needed catheterization (5.5%). There were no inpatient admissions due to complications (hematuria, sepsis). On repeat questioning at a later time point, only 25/199 (12.6%) of men said repeat biopsy would be a significant problem despite a significant and marked reduction in erectile function after the procedure. From this study, we conclude that TP biopsy is well tolerated with similar side effect profiles and attitudes of men to repeat biopsy to men having TRUS biopsies. These data allow informed counseling of men prior to TP biopsy and a benchmark for tolerability with local anesthetic TP biopsies being developed for clinical use.

Sex Differences in Patients With Different Stages of Knee Osteoarthritis

ObjectiveTo quantify the differences in physical impairments and in performance-based measures and patient-reported outcomes in men and women seeking nonoperative management of symptomatic moderate knee osteoarthritis (OA) and those with symptomatic end-stage knee OA scheduled for total knee arthroplasty compared with healthy controls. DesignCross-sectional analysis of individuals referred to physical therapy, community participants, and subjects from a 2-year longitudinal study. SettingUniversity research department. ParticipantsCross-sectional analysis of participants (N=289) consisting of a moderate OA group (n=83), a severe OA group (n=143), and a healthy control group (n=63). InterventionsNot applicable. Main Outcome MeasuresQuadriceps strength, timed Up and Go test, stair-climbing test, 6-minute walk test, Knee Outcome Survey–Activities of Daily Living Scale (KOS-ADLS), and Physical Component Summary (PCS) of the Medical Outcomes Study 36-Item Short-Form Health Survey. ResultsWomen had worse scores than men for physical impairment and performance-based measures (P<.001). In the moderate OA group, women had significantly lower KOS-ADLS (P=.007) and PCS (P=.026) scores than men, with no differences seen between sexes in the other 2 groups for patient-reported measures. ConclusionsDifferences between women and men with knee OA on physical impairments and performance-based measures are not echoed in the differences seen in patient-reported measures. These measures signal different domains of knee function in patients with knee OA and should be used as part of a comprehensive functional evaluation.

Effects of recreational soccer in men with prostate cancer undergoing androgen deprivation therapy: study protocol for the 'FC Prostate' randomized controlled trial.

BackgroundAndrogen deprivation therapy (ADT) is a cornerstone in the treatment of advanced prostate cancer. Adverse musculoskeletal and cardiovascular effects of ADT are widely reported and investigations into the potential of exercise to ameliorate the effects of treatment are warranted. The ‘Football Club (FC) Prostate’ study is a randomized trial comparing the effects of soccer training with standard treatment approaches on body composition, cardiovascular function, physical function parameters, glucose tolerance, bone health, and patient-reported outcomes in men undergoing ADT for prostate cancer.Methods/DesignUsing a single-center randomized controlled design, 80 men with histologically confirmed locally advanced or disseminated prostate cancer undergoing ADT for 6 months or more at The Copenhagen University Hospital will be enrolled on this trial. After baseline assessments eligible participants will be randomly assigned to a soccer training group or a control group receiving usual care. The soccer intervention will consist of 12 weeks of training 2–3 times/week for 45–60 min after which the assessment protocol will be repeated. Soccer training will then continue bi-weekly for an additional 20 weeks at the end of which all measures will be repeated to allow for additional analyses of long-term effects. The primary endpoint is changes in lean body mass from baseline to 12 weeks assessed by dual X-ray absorptiometry scan. Secondary endpoints include changes of cardiovascular, metabolic, and physical function parameters, as well as markers of bone metabolism and patient-reported outcomes.DiscussionThe FC Prostate trial will assess the safety and efficacy of a novel soccer-training approach to cancer rehabilitation on a number of clinically important health outcomes in men with advanced prostate cancer during ADT. The results may pave the way for innovative, community-based interventions in the approach to treating prostate cancer.Trial registrationClinicalTrials.gov: NCT01711892

The Effects of Combination Therapy with Dutasteride and Tamsulosin on Clinical Outcomes in Men with Symptomatic Benign Prostatic Hyperplasia: 4-Year Results from the CombAT Study

BackgroundCombination therapy with dutasteride and tamsulosin provides significantly greater benefit than either monotherapy for various patient-reported outcomes in men with moderate-to-severe lower urinary tract symptoms (LUTS) due to benign prostatic hyperplasia (BPH) and prostatic enlargement. ObjectiveTo investigate whether combination therapy is more effective than either monotherapy in reducing the relative risk for acute urinary retention (AUR), BPH-related surgery, and BPH clinical progression over 4 yr in men at increased risk of progression. Design, setting, and participantsThe Combination of Avodart® and Tamsulosin (CombAT) study was a 4-yr, multicenter, randomised, double-blind, parallel-group study in 4844 men ≥50 yr of age with a clinical diagnosis of BPH, International Prostate Symptom Score ≥12, prostate volume ≥30cm3, prostate-specific antigen 1.5–10ng/ml, and maximum urinary flow rate (Qmax) >5 and ≤15ml/s with minimum voided volume ≥125ml. InterventionOral daily tamsulosin, 0.4mg; dutasteride, 0.5mg; or a combination of both. MeasurementsThe 4-yr primary end point was time to first AUR or BPH-related surgery. Secondary end points included BPH clinical progression, symptoms, Qmax, prostate volume, safety, and tolerability. Results and limitationsCombination therapy was significantly superior to tamsulosin monotherapy but not dutasteride monotherapy at reducing the relative risk of AUR or BPH-related surgery. Combination therapy was also significantly superior to both monotherapies at reducing the relative risk of BPH clinical progression. Combination therapy provided significantly greater symptom benefit than either monotherapy at 4 yr. Safety and tolerability of combination therapy was consistent with previous experience with dutasteride and tamsulosin monotherapies, with the exception of an imbalance in the composite term of cardiac failure among the three study arms. The lack of placebo control is a study limitation. ConclusionsThe 4-yr CombAT data provide support for the long-term use of dutasteride and tamsulosin combination therapy in men with moderate-to-severe LUTS due to BPH and prostatic enlargement. Clinicaltrials.gov identifierNCT00090103 (http://www.clinicaltrials.gov/ct2/show/NCT00090103).