Variation across operating sites in urinary and sexual outcomes after radical prostatectomy in localized and locally advanced prostate cancer.

PURPOSE: The extent of variation in urinary and sexual functional outcomes after radical prostatectomy (RPE) between prostate cancer (PC) operating sites remains unknown. Therefore, this analysis aims to compare casemix-adjusted functional outcomes (EPIC-26 scores incontinence, irritative/obstructive function and sexual function) between operating sites 12 months after RPE. MATERIALS AND METHODS: Analysis of a cohort of 7065 men treated with RPE at 88 operating sites (prostate cancer centers, "PCCs") between 2016 and 2019. Patients completed EPIC-26 and sociodemographic information surveys at baseline and 12 months after RPE. Survey data were linked to clinical data. EPIC-26 domain scores at 12 months after RPE were adjusted for relevant confounders (including baseline domain score, clinical and sociodemographic information) using regression analysis. Differences between sites were described using minimal important differences (MIDs) and interquartile ranges (IQR). The effects of casemix adjustment on the score results were described using Cohen's d and MIDs. RESULTS: Adjusted domain scores at 12 months varied between sites, with IQRs of 66-78 (incontinence), 89-92 (irritative/obstructive function), and 20-29 (sexual function). Changes in domain scores after casemix adjustment for sites ≥ 1 MID were noted for the incontinence domain (six sites). Cohen's d ranged between - 0.07 (incontinence) and - 0.2 (sexual function), indicating a small to medium effect of casemix adjustment. CONCLUSIONS: Variation between sites was greatest in the incontinence and sexual function domains for RPE patients. Future research will need to identify the factors contributing to this variation. TRIAL REGISTRY: The study is registered at the German Clinical Trial Registry ( https://www.drks.de/drks_web/ ) with the following ID: DRKS00010774.

68Ga-Prostate-Specific Membrane Antigen Positron Emission Tomography-Computed Tomography-Based Primary Staging and Histological Correlation after Extended Pelvic Lymph Node Dissection in Intermediate-Risk Prostate Cancer.

OBJECTIVE: The objective of this study is to evaluate prostate-specific membrane antigen positron emission tomography-computed tomography (PSMA PET/CT)-based primary staging in exclusively D'Amico intermediate-risk prostate cancer (PCa) patients. PATIENTS AND METHODS: We relied on the Braunschweig institutional database and retrospectively identified D'Amico intermediate-risk PCa patients who were administered to 68Ga-PSMA PET/CT-based primary staging prior to consecutive radical prostatectomy and extended lymph node dissection. Sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) for the detection of lymph node metastases were analyzed per-patient (n = 39), per-pelvic side (n = 78), and per-anatomic-region (external iliac artery and vein left/right vs. obturator fossa left/right vs. internal iliac artery left/right) (n = 203), respectively. RESULTS: Sensitivity, specificity, PPV, and NPV per-patient were 20.0, 94.1, 33.3, and 88.9%, respectively. Sensitivity, specificity, PPV, and NPV per-pelvic-side were 16.7, 97.2, 33.3, and 93.3%, respectively. Sensitivity, specificity, PPV, and NPV per-anatomic-region were 16.7, 99.0, 33.3, and 97.5%, respectively. CONCLUSIONS: We recorded high rates of specificity and NPV for 68Ga-PSMA PET/CT-based primary staging in D'Amico intermediate-risk PCa patients. Conversely, the sensitivity and PPV were lower than anticipated. Larger and favorably prospective trials are needed to verify our results and to unravel possible bias from such smaller studies.

Psychometric validation of the German version of the EPIC-26 questionnaire for patients with localized and locally advanced prostate cancer.

PURPOSE: For patients with prostate cancer, validated and reliable instruments are essential for measuring patient-reported outcomes. The aim of this study was to validate the German version of the widely established Expanded Prostate Cancer Index Composite with 26 items (EPIC-26). METHODS: A German translation of the original questionnaire was tested in 3094 patients with localized or locally advanced (any T, any N and M0) prostate cancer with treatment intent (including radical prostatectomy, brachytherapy, active surveillance, watchful waiting). They completed the EPIC-26 questionnaire before treatment. A total of 521 of them also completed a questionnaire 12 months afterward. Internal consistency, sensitivity to change, and construct validity were assessed. RESULTS: The internal consistency of all domains was sufficient (Cronbach's alpha between 0.64 and 0.93). Item-to-scale correlation coefficients showed acceptable associations between items and their domain score (all > 0.30), with the lowest scores for "bloody stools" (r = 0.37) and "breast problems" (r = 0.32). Confirmatory and exploratory factor analysis confirmed the five-dimension structure of the EPIC-26 (comparative fit index 0.95). CONCLUSIONS: Psychometric evaluation suggests that the German version of the EPIC-26 is a well-constructed instrument for measuring patient-reported health-related symptoms in patients with prostate cancer.

Elastography Targeted Prostate Biopsy in Patients under Active Surveillance.

OBJECTIVE: The aim of this study was to examine elastography-based prostate biopsy in prostate cancer (PCa) patients under active surveillance. PATIENTS AND METHODS: We relied on PCa patients who opted for active surveillance and underwent elastography targeted and systematic follow-up biopsy at the Braunschweig Prostate Cancer Center between October 2009 and February 2015. Each prostate sextant was considered as an individual case. Sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV), and accuracy (ACC) for elastography to predict follow-up biopsy results were analyzed, respectively, and 95 % confidence intervals (CIs) were carried out by using 2000 bootstrapping sample analyses. RESULTS: Overall, 50 men and 300 sextants were identified. Overall, 27 (54%) men and 66 (22%) sextants harbored PCa at follow-up biopsy. Sensitivity, specificity, PPV, NPV, and ACC for elastography to predict follow-up biopsy results were: 19.7 (95% CI: 11.9-27.3), 86.8 (95% CI: 82.7-90.3), 29.6 (95% CI: 14.6-46.0), 79.3 (95% CI: 71.6-86.5), and 72.0% (95% CI: 65.7-78.3), respectively. CONCLUSIONS: We recorded limited reliability of elastography-based prediction of follow-up biopsy results in active surveillance patients. Based on our analyses, we can neither recommend to rely exclusively on elastography-based targeted biopsies nor to delay or to omit follow-up biopsies based on elastography results during active surveillance.

Only Size Matters in Stone Patients: Computed Tomography Controlled Stone-Free Rates after Mini-Percutaneous Nephrolithotomy.

OBJECTIVE: To examine and predicting stone-free rates (SFRs) after minimally invasive-percutaneous nephrolithotomy (mini-PNL) based on computed tomography (CT), instead of X-ray or ultrasound control. PATIENTS AND METHODS: We identified 146 mini-PNL patients with pre- and postoperative CT scans. Patient and stone characteristics were assessed. Stone-free status was defined as ≤3 mm residual fragment after mini-PNL according to postsurgery CT scan. Multivariable logistic regression analyses predicted stone-free status after mini-PNL. RESULTS: Overall, 62 (42.5%) patients achieved stone-free status after mini-PNL. In multivariable analyses, stone size was the only independent predictor for stone-free status (OR 0.9; p = 0.02). Patients with stones > 20 mm were less likely to achieve stone-free status, than those harboring stones 10-20 mm (OR 0.3; p = 0.009). SFRs according to stone size categories (< 10, 10-20, and > 20 mm) were 33.3, 50.5, and 25%. Body mass index (BMI) and stone density (Houndsfield units) were no independent predictors for stone-free status after mini-PNL. CONCLUSIONS: We report lower SFRs than expected. Stone size was the only independent predictor for stone-free status after mini-PNL. Patients with larger stones need to be informed about high risk of additional interventions. High BMI and high stone density do not represent a barrier for stone-free status after mini-PNL.

PSA response to cabazitaxel is associated with improved progression-free survival in metastatic castration-resistant prostate cancer: the non-interventional QoLiTime study.

PURPOSE: To evaluate the association between prostate-specific antigen (PSA) response and progression-free and overall survival in men with metastatic castration-resistant prostate cancer (mCRPC) treated with cabazitaxel. METHODS: Men with mCRPC receiving cabazitaxel (25 mg/m2, every 3 weeks) plus oral prednis(ol)one (10 mg/day) were enrolled in the non-interventional, prospective QoLiTime study. Main outcome measures were progression-free survival and overall survival, in all patients and in those who showed a ≥ 50 or a ≥ 30% decrease in PSA relative to baseline after four cycles of cabazitaxel, as well as quality-of-life parameters. RESULTS: Of the 527 men (median age 72 years), 266 received ≥ 4 cycles of cabazitaxel and had PSA response data. After four cycles, 34.6% of men achieved a PSA decrease ≥ 50% and 49.6% a decrease ≥ 30%. Median progression-free survival was 7.7 (95% CI 6.2, 9.5) months, and overall survival was 19.5 (95% CI 16.0, 30.9) months, corresponding to 1-year event rates of 39.4 and 78.8%, respectively. Median progression-free survival was longer in PSA responders versus non-responders (15.7 vs 5.5 months at 50% cut-off; 15.7 vs 5.3 months for 30% cut-off; both P < 0.0001). Overall survival (50% cut-off) was 23.3 months in responders and 16.0 months in non-responders (P = 0.068); corresponding data at the 30% cut-off are 21.7 and 16.0 months (P = 0.057). Overall, 55.4% of men experienced ≥ 1 adverse event, 59.6% of whom had a serious adverse event. CONCLUSION: PSA response after four cycles of cabazitaxel is associated with improved progression-free survival in men with mCRPC treated with cabazitaxel plus prednis(ol)one.

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

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

Health-Related Quality of Life in 536 Long-Term Prostate Cancer Survivors after Treatment with Leuprorelin Acetate: A Combined Retrospective and Prospective Analysis.

INTRODUCTION: We investigated the health-related quality of life (HRQoL) of long-term prostate cancer patients who received leuprorelin acetate in microcapsules (LAM) for androgen-deprivation therapy (ADT). METHODS: The observational study was carried out by 30 office-based German urologists in 536 prostate cancer (PCa) patients treated for ≥5 years with LAM and in 116 patients of an age-matched control group (CG). Data on HRQoL and health status was collected prospectively using validated questionnaires QLQ-C30, QLQ-PR25 and Karnofsky Index. Data on effectiveness (clinical response, prostate specific antigen [PSA], testosterone) and safety was collected retrospectively from patients' health records. We used descriptive statistics to analyze the data. RESULTS: The mean treatment duration was 8.6 years (range 4.5-19.8 years). General health status (QLQ-C30) was comparable for both groups. Differences were observed regarding physical - and role functioning. ADT patients rated single items slightly worse than CG. Karnofsky-Index showed comparable high values (median of 90%). QLQ-PR25 revealed more PCa-related symptoms for ADT patients. Within 6 months, median PSA level declined >90% and median testosterone levels declined below castration level from 4.0 to 0.2 ng/mL. Clinical response (European Organisation for Research and Treatment of Cancer criteria) was observed in at least 90% of ADT patients. CONCLUSIONS: Long-term ADT with LAM is a well-accepted, tolerated, effective, and low-burden treatment option for patients with advanced, hormone-sensitive PCa.

Quality of life and pain relief in men with metastatic castration-resistant prostate cancer on cabazitaxel: the non-interventional 'QoLiTime' study.

OBJECTIVE: To examine health-related quality of life (QoL) in men with metastatic castration-resistant prostate cancer (mCRPC) on cabazitaxel. PATIENTS AND METHODS: Men with mCRPC receiving cabazitaxel (25 mg/m², every 3 weeks) and 10 mg/day oral prednis(ol)one were enrolled (2011-2014) in the non-interventional prospective 'QoLiTime' study. Primary outcome was change in QoL (European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire 30-item) with respect to prostate-specific antigen (PSA) response after four cycles of cabazitaxel. Secondary outcomes included occurrence of adverse events (AEs). RESULTS: Of 527 men, 348 received four cycles of cabazitaxel and 266 had the necessary PSA level measurements. After four cycles, 92 (34.6%) men had a PSA level decrease ≥50% (responders). QoL remained stable throughout the study (P = 0.62). Change in QoL did not differ between responders and non-responders (P = 0.69). Change in PSA level and global health status between baseline and four cycles showed an inversely proportional relationship (correlation coefficient -0.14; 95% confidence interval -0.26 to -0.01; P = 0.03), with increasing PSA level corresponding to lower health status. Responders showed no change in physical functioning vs baseline (-1.75, P = 0.12); non-responders showed a reduction vs baseline (-7.00, P < 0.001) and responders (P = 0.05). Responders showed an improvement in pain vs baseline (-7.61, P = 0.05) and vs non-responders (P = 0.01). AEs occurred in 292 patients (55.4%), most commonly anaemia (16.5%), fatigue (12.3%) and diarrhoea (11.8%). Neutropenia and febrile neutropenia were reported in 3.8% and 3.6% of patients, respectively. CONCLUSION: Prostate-specific antigen level response was associated with stable physical functioning and improvement in pain. Symptom increases were seen in areas typical of chemotoxicity, but QoL was maintained.

Limitations of Elastography Based Prostate Biopsy.

PURPOSE: The role of elastography in patients initially and at repeat prostate biopsy is still indeterminate. The existing literature is sparse and controversial. MATERIALS AND METHODS: We studied patients who underwent elastography based and systematic biopsy between October 2009 and February 2015 at Braunschweig Prostate Cancer Center. Patients were separated according to first vs repeat biopsy setting. Each prostate sextant was considered an individual case. The sensitivity, specificity, positive and negative predictive values, and accuracy of elastography to predict biopsy results were analyzed. The 95% CIs were determined by bootstrapping analysis of 2,000 samples. RESULTS: Overall 679 men and a total of 4,074 sextants were identified. Of the 679 men 160 (23.6%) underwent first biopsy and 519 (76.4%) underwent repeat biopsy. In the 160 men at first biopsy sensitivity was 18.0% (95% CI 14.5-21.3), specificity was 87.7% (95% CI 85.3-89.9), positive predictive value was 36.6% (95% CI 28.4-45.4), negative predictive value was 73.0% (95% CI 67.5-77.9) and accuracy was 67.9% (95% CI 63.4-72.2). Results in 519 men (76.4%) at repeat biopsy were 19.8% (95% CI 16.0-23.7), 90.9% (95% CI 89.9-91.9), 20.1% (95% CI 15.8-24.8), 90.7% (95% CI 89.0-92.3) and 83.5% (95% CI 81.6-85.2), respectively. CONCLUSIONS: We found limited reliability of elastography prediction at prostate biopsy in patients at first and repeat biopsies. Based on our analyses we cannot recommend a variation of well established systematic biopsy patterns or a decrease in biopsy cores based on elastography.

Non-metastatic castrate-resistant prostate cancer: a call for improved guidance on clinical management.

BACKGROUND: Guidelines on the clinical management of non-metastatic castrate-resistant prostate cancer (nmCRPC) generally focus on the need to continue androgen deprivation therapy and enrol patients into clinical trials of investigational agents. This guidance reflects the lack of clinical trial data with established agents in the nmCRPC patient population and the need for trials of new agents. AIM: To review the evidence base and consider ways of improving the management of nmCRPC. CONCLUSION: Upon the development of castrate resistance, it is essential to rule out the presence of metastases or micrometastases by optimising the use of bone scans and possibly newer procedures and techniques. When nmCRPC is established, management decisions should be individualised according to risk, but risk stratification in this diverse population is poorly defined. Currently, prostate-specific antigen (PSA) levels and PSA doubling time remain the best method of assessing the risk of progression and response to treatment in nmCRPC. However, optimising imaging protocols can also help assess the changing metastatic burden in patients with CRPC. Clinical trials of novel agents in nmCRPC are limited and have problems with enrolment, and therefore, improved risk stratification and imaging may be crucial to the improved management. The statements presented in this paper, reflecting the views of the authors, provide a discussion of the most recent evidence in nmCRPC and provide some advice on how to ensure these patients receive the best management available. However, there is an urgent need for more data on the management of nmCRPC.

True targeting-derived prostate biopsy: HistoScanning™ remained inadequate despite advanced technical efforts.

PURPOSE: To verify the reliability of HistoScanning™-based, true targeting (TT)-derived prostate biopsy. METHODS: We relied on 40 patients suspicious for prostate cancer who underwent standard and TT-derived prostate biopsy. Sensitivity, specificity, positive predictive value, negative predictive value and the area under the curve (AUC) were assessed for the prediction of biopsy results per octant by HistoScanning™, using different HistoScanning™ signal volume cutoffs (>0, >0.2 and >0.5 ml). RESULTS: Overall, 319 octants were analyzed. Of those, 64 (20.1 %) harbored prostate cancer. According to different HistoScanning™ signal volume cutoffs (>0, >0.2 and >0.5 ml), the AUCs for predicting biopsy results were: 0.51, 0.51 and 0.53, respectively. Similarly, the sensitivity, specificity, positive predictive and negative predictive values were: 20.7, 78.2, 17.4 and 81.6 %; 20.7, 82.0, 20.3 and 82.3 %; and 12.1, 94.6, 33.3 and 82.9 %, respectively. CONCLUSIONS: Prediction of biopsy results based on HistoScanning™ signals and TT-derived biopsies was unreliable. Moreover, the AUC of TT-derived biopsies was low and did not improve when additional signal volume cutoffs were applied (>0.2 and >0.5 ml). We cannot recommend a variation of well-established biopsy standards or reduction in biopsy cores based on HistoScanning™ signals.

Incidence of prostate cancer in hypogonadal men receiving testosterone therapy: observations from 5-year median followup of 3 registries.

PURPOSE: Although there is no evidence that testosterone therapy increases the risk of prostate cancer, there is a paucity of long-term data. We determined whether the incidence of prostate cancer is increased in hypogonadal men receiving long-term testosterone therapy. MATERIALS AND METHODS: In 3 parallel, prospective, ongoing, cumulative registry studies 1,023 hypogonadal men received testosterone therapy. Two study cohorts were treated by urologists (since 2004) and 1 was treated at an academic andrology center (since 1996). Patients were treated when total testosterone was 12.1 nmol/l or less (350 ng/dl) and symptoms of hypogonadism were present. Maximum followup was 17 years (1996 to 2013) and median followup was 5 years. Mean baseline patient age in the urological settings was 58 years and in the andrology setting it was 41 years. Patients received testosterone undecanoate injections in 12-week intervals. Pretreatment examination of the prostate and monitoring during treatment were performed. Prostate biopsies were performed according to EAU guidelines. RESULTS: Numbers of positive and negative biopsies were assessed. The incidence of prostate cancer and post-prostatectomy outcomes was studied. A total of 11 patients were diagnosed with prostate cancer in the 2 urology settings at proportions of 2.3% and 1.5%, respectively. The incidence per 10,000 patient-years was 54.4 and 30.7, respectively. No prostate cancer was reported by the andrology center. Limitations are inherent in the registry design without a control group. CONCLUSIONS: Testosterone therapy in hypogonadal men does not increase the risk of prostate cancer. If guidelines for testosterone therapy are properly applied, testosterone treatment is safe in hypogonadal men.

Androgen deprivation therapy in castrate-resistant prostate cancer: how important is GnRH agonist backbone therapy?

BACKGROUND: A growing number of treatment options exist to treat metastatic castrate-resistant prostate cancer (mCRPC), and with these newer options, many questions about optimising treatment remain unanswered. One recommendation that may potentially be overlooked by practitioners is that androgen deprivation therapy (ADT) should be maintained when CRPC develops and when treatment with any of the newer agents is initiated. AIM: However, to emphasise this recommendation, it is valuable to interrogate the evidence for maintaining ADT in different clinical situations. OUTCOME: This statement, reflecting the views of the authors, provides a discussion of this evidence and the rationale behind the recommendation that ADT should be continued in CRPC.

Controversial evidence for the use of HistoScanning™ in the detection of prostate cancer.

INTRODUCTION: Given the growing body of literature since first description of HistoScanning™ in 2008, there is an unmet need for a contemporary review. EVIDENCE ACQUISITION: Studies addressing HistoScanning™ in prostate cancer (PCa) were considered to be included in the current review. To identify eligible reports, we relied on a bibliographic search of PubMed database conducted in January 2015. EVIDENCE SYNTHESIS: Twelve original articles were available to be included in the current review. The existing evidence was reviewed according to the three following topics: prediction of final pathology at radical prostatectomy, prediction of disease stage and application at prostate biopsy. CONCLUSIONS: High sensitivity and specificity for HistoScanning™ to predict cancer foci ≥0.5 ml at final pathology were achieved in the pilot study. These results were questioned, when HistoScanning™ derived tumor volume does not correlate with final pathology results. Additionally, HistoScanning™ was not able to provide reliable staging information according to neither extraprostatic extension, nor seminal vesicle invasion prior to radical prostatectomy. Controversy data also exist according to the use of HistoScanning™ at prostate biopsy. Specifically, most encouraging results were recorded in a small patient cohort. Conversely, HistoScanning™ achieved poor prediction of positive biopsies, when relying on larger studies. Finally, the combination of HistoScanning™ and conventional ultrasound achieved lower detection rates than systematic biopsy. Currently, evidence is at best weak and questions whether HistoScanning™ might improve the detection of PCa.

Prostate Biopsy Core Handling: Comparison of Contemporary Preembedding Methods.

INTRODUCTION: The probability of prostate cancer detection is related to the amount of tissue represented. For optimal tissue representation, the specimens should preserve their regular cylindrical shape and avoid artefacts and deformation caused by fixation and preembedding. The aim of our study was to compare contemporary preembedding methods including a new method of using thick cardboard. MATERIALS AND METHODS: To compare the preembedding methods, we took 36 nonfragmented cores from fresh prostatectomy specimens for each method, fixed them in formalin and made histological slides. The comparison criteria were a core section area in the middle section and the number of fragments per core after processing. RESULTS: Two methods (preembedding on the edge of thick cardboard and on biplicated paper) provided a bigger section area of specimens. The differences in amounts of fragments were very small among the methods mentioned above and the preembedding glass with grooves, but preembedding between two sponges in a histological cassette showed higher fragmentation. CONCLUSIONS: Preembedding on the edge of thick cardboard and on biplicated paper can be recommended as effective methods of prostate biopsy core fixation. Paper or cardboard for fixation of prostate biopsy cores should be presoaked with formalin or normal saline.

Combined testosterone and vardenafil treatment for restoring erectile function in hypogonadal patients who failed to respond to testosterone therapy alone.

INTRODUCTION: The role of testosterone in erectile dysfunction (ED) is increasingly recognized. It is suggested that assessment of testosterone deficiency in men with ED and symptoms of hypogonadism, prior to first-line treatment, may be a useful tool for improving therapy. AIM: In this prospective, observational, and longitudinal study, we investigated the effects of vardenafil treatment as adjunctive therapy to testosterone undecanoate in hypogonadal ED patients who failed to respond to testosterone treatment alone. METHODS: One hundred twenty-nine testosterone deficient (serum total testosterone ≤ 3.4 ng/mL) patients aged 56 ± 3.9 years received intramuscular injections of long-acting parenteral testosterone undecanoate at 3-month intervals for 8 months mean follow-up. MAIN OUTCOME MEASURES: Scores on the International Index of Erectile Function Questionnaire-five items (IIEF-5) and partner survey scores were compared at baseline and posttreatment with testosterone therapy alone or in combination with vardenafil. Patient baseline demographics and concomitant disease were correlated with patients' IIEF-5 scores. RESULTS: Seventy one (58.2%) responded well to monotherapy within 3 months. Nonresponders had lower testosterone levels and higher rates of concomitant diseases and smoking. Thirty-four of the 51 nonresponders accepted the addition of 20 mg vardenafil on demand. Efficacy assessments were measured by the IIEF-erectile function domain (IIEF-EF, questions 1-5 plus 15, 30 points) and partner self-designed survey at baseline after 4-6 weeks and at study end point. Thirty out of 34 patients responded well to this combination. IIEF-EF Sexual Health Inventory for Men score improved from 12 to 24 (P < 0.0001), and partner survey showed significantly higher satisfaction (P < 0.001). These patients reported spontaneous or nocturnal and morning erections or tumescence. No changes in adverse effects were recorded. CONCLUSIONS: These data suggest that combination therapy of testosterone and vardenafil is safe and effective in treating hypogonadal ED patients who failed to respond to testosterone monotherapy.

Long-term testosterone treatment in elderly men with hypogonadism and erectile dysfunction reduces obesity parameters and improves metabolic syndrome and health-related quality of life.

INTRODUCTION: Late-onset hypogonadism (LOH) is diagnosed when declining testosterone concentrations in the aging male cause unwanted symptoms such as erectile dysfunction (ED), reduced bone density and muscle strength, and increased visceral obesity. Testosterone deficiency is also associated with insulin resistance and the metabolic syndrome (MetS). Restoring testosterone to physiological concentrations has beneficial effects on many of these symptoms; however, it is not known whether these effects can be sustained in the long term. AIMS: To investigate whether treatment with testosterone undecanoate (TU) has a long-term and sustained effect on parameters affected by the MetS in men with LOH and ED, to determine whether long-term testosterone treatment can improve the overall health-related quality of life in these men, and to establish the safety of long-term testosterone treatment. METHODS: Two hundred sixty-one patients (mean age 59.5 ± 8.4 years) diagnosed with LOH and ED were treated with long-acting TU in a prospective, observational, and longitudinal registry study. Men received intramuscular injections of 1,000 mg TU at day 1, at week 6, and every 3 months thereafter. MAIN OUTCOME MEASURES: Parameters affected by the MetS, including obesity parameters (body weight, waist circumference, and body mass index [BMI]), total cholesterol, low-density lipoprotein (LDL), high-density lipoprotein (HDL), triglycerides, glucose, HbA1c (glycated hemoglobin), and blood pressure, as well as total testosterone levels and health-related quality of life, were assessed. RESULTS: We found TU significantly improved obesity parameters (body weight, waist circumference, and BMI) and lowered total cholesterol, LDL cholesterol, triglycerides, fasting blood glucose, HbA1c , and blood pressure over the 5-year study. HDL cholesterol was increased. TU treatment resulted in a sustained improvement in erectile function and muscle and joint pain, which contributed to an improvement in long-term health-related quality of life. Furthermore, we found a relationship between health-related quality of life and waist circumference. Finally, we found no evidence that long-term treatment with TU increases the risk of prostate carcinoma. CONCLUSION: Long-term TU in men with LOH and ED reduces obesity parameters and improves metabolic syndrome and health-related quality of life.

Lower urinary tract symptoms improve with testosterone replacement therapy in men with late-onset hypogonadism: 5-year prospective, observational and longitudinal registry study.

PURPOSE: Many men with "late-onset hypogonadism" (LOH) experience lower urinary tract symptoms (LUTS) that can be distressing and may decrease quality of life. LUTS often appear in men when testosterone levels begin to decline, which could be a significant association. We investigated whether testosterone replacement could alleviate LUTS in men with LOH. METHODS: Two hundred and sixty-one hypogonadal patients (mean age 59.5 years) presenting with erectile dysfunction, having also been evaluated for LUTS, received a single testosterone undecanoate injection at day 1, at week 6 and quarterly thereafter. Parameters, including International Prostate Symptom Score (IPSS), post-voiding residual urine volume, transrectal ultrasound, prostate volume and prostate-specific antigen were measured at each treatment visit. Two hundred and fifty-nine patients were included in the full analysis set. These were subsequently divided into weight losers (L ≥ 5 % weight loss at last visit from baseline) and non-losers (NL). t test analyses were used to compare the IPSS means of these subgroups. The potentially confounding effect on IPSS of using the phosphodiesterase-5 inhibitor (PDE5i) vardenafil was also accounted for. RESULTS: Mean IPSS showed a significant decrease with time following initiation of testosterone treatment (p < 0.05). No significant differences were observed in either IPSS between L and NL groups or in mean IPSS between vardenafil users and non-users. CONCLUSION: Testosterone replacement is associated with improvements in LUTS which are not confounded by weight loss or PDE5i. The mechanisms of this association require further investigation.

[Urinary incontinence after radical prostatectomy for prostate cancer-data from 17,149 patients from 125 certified centers]. / Harninkontinenz nach radikaler Prostatektomie beim Prostatakarzinom ­ aktuelle Daten von 17.149 Patienten aus 125 zertifizierten Zentren.

BACKGROUND: In addition to erectile dysfunction, urinary incontinence is the most common functional limitation after radical prostatectomy (RPE) for prostate cancer (PCa). The German S3 guideline 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. OBJECTIVE: The aim of this work is to present data on the frequency and severity of urinary incontinence after RPE from routine care. MATERIALS AND METHODS: 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 12 months after RPE (T1) and the proportion of patients who used pads, stratified by age and risk group, are reported. RESULTS: The average score for urinary incontinence (value range: 0-worst possible to 100-best possible) was 93 points at T0 and 73 points 12 months later. At T0, 97% of the patients did not use a pad, compared to 56% at T1. 43% of the patients who did not use a pad before surgery used at least one pad a day 12 months later, while 13% use two or more. The proportion of patients using pads differs by age and risk classification. CONCLUSION: The results provide a comprehensive insight into functional outcome 12 months after RPE and can be taken into account when informing patients.