[The interoperability of IIEF-5 with EPIC-26 : Sexual function after radical prostatectomy]. / Die Übertragbarkeit von IIEF-5 (International Index of Erectile Function 5 Item Short Form) auf EPIC-26 (Expanded Prostate Cancer Index Composite 26) : Sexuelle Funktion nach radikaler Prostatektomie.

BACKGROUND: In the past, the IIEF­5 (International Index of Erectile Function 5 ) was predominantly used to measure erectile function in prostate cancer patients. Following international developments, the domain "sexuality" of the EPIC-26 (Expanded Prostate Cancer Index Composite 26) is increasingly used in Germany. OBJECTIVE: The aim of this work is to create a practicable comparison of the domain "sexuality" of the EPIC-26 with the IIEF­5 for treatment in Germany. This is particularly necessary for the evaluation of historical patient collectives. MATERIALS AND METHODS: For the evaluation, 2123 patients with prostate cancer confirmed by biopsy from 2014-2017 who completed both the IIEF­5 and the EPIC-26 were considered. Linear regression analyses are calculated to convert IIEF­5 sum scores to EPIC-26 sexuality domain scores. RESULTS: The correlation between IIEF­5 and the EPIC-26 domain score "sexuality" was 0.74, suggesting a high degree of content convergence between the constructs measured. While the standard error of the predicted values is relatively small, the prediction intervals are very wide. For example, for the critical IIEF­5 value of 22, the predicted value is 78.88 with a 95% prediction interval of 55.09 to 102.66. CONCLUSION: IIEF­5 and the Sexuality scale of the EPIC-26 measure a similar construct. The analysis shows that conversion of individual values is associated with great uncertainty. However, at the group level, the observed EPIC-26 "sexuality" score could be predicted quite accurately. This opens up the possibility of comparing the erectile function of cohorts of patients/test persons, even if this was collected with different measuring instruments.

[Quality criteria in urology : How to obtain comparable results?] / Qualitätskriterien in der Urologie : Wie kann eine Vergleichbarkeit der Ergebnisse geschaffen werden?

The standardization of procedural flow and medical documentation increasingly allows further possibilities. The best-known example of process standardization is the centralized treatment of complex clinical pictures, while patient-reported outcome measurements (PROMs) enable standardized documentation. Using the example of prostate cancer, existing literature on the topic of quality optimization in medicine is discussed. The following key points are addressed: (1) Increasing use of standardized PROMs for outcome documentation. (2) The transfer of complex clinical pictures to dedicated specialized centers has been shown to increase the quality of patient care as long as standardized PROMs are used. (3) Healthcare policymakers benefit from the use of PROMs and increasingly pursue a "value-based healthcare" approach.

[Treatment concepts for primary oligometastatic prostate cancer]. / Therapiekonzepte beim primär oligometastasierten Prostatakarzinom.

BACKGROUND: About 5% of prostate cancer patients have distant metastases at diagnosis. In these metastatic hormone-sensitive prostate cancers (mHSPC), systemic therapy is recommended, according to the guidelines. Moreover, metastasis-directed therapy (MDT) is discussed to prolong survival. OBJECTIVES: The contemporary literature concerning local therapy and MDT in patients with mHSPC is summarized. METHODS: Selective literature search. RESULTS: In 2018, randomized controlled data on local therapy in mHSPC patients were published by the authors of the STAMPEDE study. Here, patients were randomized between standard of care (SOC) ± radiotherapy to the prostate (RT). Within the overall cohort, no difference regarding 3­year overall survival (OS) was observed. Within a prespecified subgroup of patients with low metastatic burden. Similar results were observed in numerous retrospective studies analyzing radical prostatectomy; prospective randomized studies are pending. For MDT, there are no sufficient data in mHSPC patients yet. CONCLUSIONS: In the current guidelines, systematic therapy is standard of care in mHSPC patients. In patients with low metastatic burden, a survival benefit was observed when adding percutaneous RT to the prostate. Retrospective studies also suggest a benefit when adding RP. However, whether MDT prolongs survival is still unknown.

Correction to: The natural course of pT2 prostate cancer with positive surgical margin: predicting biochemical recurrence.

In multivariate analysis, GS of the regular prostatectomy specimen was the only statistically significant parameter for pT2R1 prostate cancer.

Standard of Care Versus Metastases-directed Therapy for PET-detected Nodal Oligorecurrent Prostate Cancer Following Multimodality Treatment: A Multi-institutional Case-control Study.

BACKGROUND: Most prostate cancer (PCa) patients with a biochemical failure following primary multimodality treatment (surgery and postoperative radiotherapy) relapse in the nodes. OBJECTIVE: To perform a matched-case analysis in men with lymph node recurrent PCa comparing standard of care (SOC) with metastasis-directed therapy (MDT). DESIGN, SETTING, AND PARTICIPANTS: PCa patients with a prostate-specific antigen (PSA) progression following multimodality treatment were included in this retrospective multi-institutional analysis. INTERVENTION: The SOC cohort (n=1816) received immediate or delayed androgen deprivation therapy administered at PSA progression. The MDT cohort (n=263) received either salvage lymph node dissection (n=166) or stereotactic body radiotherapy (n=97) at PSA progression to a positron emission tomography-detected nodal recurrence. OUTCOME MEASUREMENTS AND STATISTICAL ANALYSIS: The primary endpoint, cancer-specific survival (CSS), was analyzed using the Kaplan-Meier method, log-rank test, Cox proportional hazards models, and propensity score-matched analyses. RESULTS AND LIMITATIONS: At a median follow-up of 70 (interquartile range: 48-98) mo, MDT was associated with an improved CSS on univariate (p=0.029) and multivariate analysis (hazard ratio: 0.33, 95% confidence interval [CI]: 0.17-0.64) adjusted for the year of radical prostatectomy (RP), age at RP, PSA at RP, time from RP to PSA progression, Gleason score, surgical margin status, pT- and pN-stage. In total, 659 men were matched (3:1 ratio). The 5-yr CSS was 98.6% (95% CI: 94.3-99.6) and 95.7% (95% CI: 93.2-97.3) for MDT and SOC, respectively (p=0.005, log-rank). The main limitations of our study are its retrospective design and lack of standardization of systemic treatment in the SOC cohort. CONCLUSIONS: MDT for nodal oligorecurrent PCa improves CSS as compared with SOC. These retrospective data from a multi-institutional pooled analysis should be considered as hypothesis-generating and inform future randomized trials in this setting. PATIENT SUMMARY: Prostate cancer patients experiencing a lymph node recurrence might benefit from local treatments directed at these lymph nodes.

[Metronomic chemotherapy with oral cyclophosphamide : An individual option for the metastatic castration-resistant prostate cancer patient?] / Metronomische Chemotherapie mit oralem Cyclophosphamid : Eine individuelle Option für den metastasierten kastrationsresistenten Prostatakarzinompatienten?

BACKGROUND: Multiple experimental approaches are meanwhile available for progressive metastatic castration resistant prostate cancer (mCRPC) patients after failure of guideline recommended therapy (i. e., chemotherapy and/or hormonal treatment). We evaluated the outcome of metronomic chemotherapy with cyclophosphamide (CY) in combination with low-dose prednisolone. MATERIALS AND METHODS: A total of 14 mCRPC-patients were treated with CY 50 mg/day (plus prednisolone 10 mg/day) between November 2012 and September 2017 after being resistant or unfit for chemotherapy and/or further hormonal treatment. Time to progression and overall survival (OS) were retrospectively determined by using Kaplan-Meier curves. RESULTS: Eight of 14 (57.1%) patients had undergone radical prostatectomy and 2 (14.3%) external beam radiation. All patients had at least three therapy lines and 50% had ≥5 mCRPC therapies. The median time from first diagnosis to mCRPC was 88 months; the median age was 78 years with a median baseline serum prostate-specific antigen (PSA) level of 341 ng/ml. With a median follow-up of 16.4 months, progression-free survival (PFS) was 71, 64, and 43% after 2, 4, and 6 months, respectively. Median OS was 8.1 months. No relevant adverse events occurred. CONCLUSION: Since CY is a well-tolerated medication with partially good clinical tumor control, it seems to be a convenient, individual treatment option in progressive mCRPC patients after failure of guideline recommended therapy.

[Social Inequality in Utilization of Aftercare Services Among Breast and Prostate Cancer Patients]. / Soziale Ungleichheit bei der Inanspruchnahme onkologischer Versorgungsangebote.

OBJECTIVES: This study examines social inequalities in the utilization of medical rehabilitation, complementary and alternative medicine (CAM) and psychosocial support programs among patients with prostate and breast cancer after surgery. METHOD: A prospective, multicenter observational study was conducted. Subjects were 483 patients after primary manifestation of prostate and breast cancer (UICC-Stadium 0-IV) aged between 18 and 65 years. Patients were asked to fill out a questionnaire after surgery and 6 months later. Social inequality was measured by education, income and occupational status. In addition, the insurance status (private vs. statutory) was taken into account. Logistic regression models were used separately for each cancer site. The analyses were controlled for age, tumor stage and mental comorbidity. RESULTS: The associations between social inequality and the utilization of aftercare services vary by inequality indicator and the different health care services. Inequalities in utilization of CAM are most pronounced and consistent. Differences between status groups are small in utilization of rehabilitation. Among breast cancer patients, inequalities are more pronounced than among prostate cancer patients. CONCLUSION: Social inequalities in utilization of aftercare services among breast and prostate cancer patients are inconsistent. Future investigations should clarify to what extent such inequalities are due to access barriers or due to differences in health literacy or preferences.

[Radical prostatectomy in locally advanced prostate cancer]. / Radikale Prostatektomie beim klinisch lokal fortgeschrittenen Prostatakarzinom.

BACKGROUND: Due to an inverse stage migration, the proportion of patients with more aggressive and locally advanced prostate cancer (PCa) has increased over the last few years. The natural history in these patients shows a higher risk of local complications and worse oncologic outcome. OBJECTIVES: To analyze the impact of radical prostatectomy (RP) in patients with locally advanced PCa. MATERIALS AND METHODS: A review of the literature was performed using PubMed and MEDLINE databases focusing on articles addressing locally advanced PCa. RESULTS: Current guidelines recommend local therapy in patients with locally advanced PCa among other treatment options. Thereby no strong evidence favoring radiotherapy or RP is present. Compared to patients without local treatment, RP may improve oncologic outcome and decrease the risk of local complications. Due to more difficult surgery and an increased need of multimodal therapy, higher perioperative morbidity and worse functional outcomes compared to patients with localized PCa are reported. No reliable prospective data indicating a widespread use of neoadjuvant treatment exists. Indication for further adjuvant or salvage therapies depends on pathologic results and postoperative course. CONCLUSIONS: RP is one of the treatment options with good long-term results which can be offered to patients with locally advanced PCa. Nevertheless, patients need to be counselled especially about the worse postoperative functional outcome compared to patients with localized PCa.

The survival impact of neoadjuvant hormonal therapy before radical prostatectomy for treatment of high-risk prostate cancer.

BACKGROUND: Several randomized controlled trials assessed the outcomes of patients treated with neoadjuvant hormonal therapy (NHT) before radical prostatectomy (RP). The majority of them included mainly low and intermediate risk prostate cancer (PCa) without specifically assessing PCa-related death (PCRD). Thus, there is a lack of knowledge regarding a possible effect of NHT on PCRD in the high-risk PCa population. We aimed to analyze the effect of NHT on PCRD in a multicenter high-risk PCa population treated with RP, using a propensity-score adjustment. METHODS: This is a retrospective multi-institutional study including patients with high-risk PCa defined as: clinical stage T3-4, PSA >20 ng ml-1 or biopsy Gleason score 8-10. We compared PCRD between RP and NHT+RP using competing risks analysis. Correction for group differences was performed by propensity-score adjustment. RESULTS: After application of the inclusion/exclusion criteria, 1573 patients remained for analysis; 1170 patients received RP and 403 NHT+RP. Median follow-up was 56 months (interquartile range 29-88). Eighty-six patients died of PCa and 106 of other causes. NHT decreased the risk of PCRD (hazard ratio (HR) 0.5; 95% confidence interval (CI) 0.32-0.80; P=0.0014). An interaction effect between NHT and radiotherapy (RT) was observed (HR 0.3; 95% CI 0.21-0.43; P<0.0008). More specifically, of patients who received adjuvant RT, those who underwent NHT+RP had decreased PCRD rates (2.3% at 5 year) compared to RP (7.5% at 5 year). The retrospective design and lack of specific information about NHT are possible limitations. CONCLUSIONS: In this propensity-score adjusted analysis from a large high-risk PCa population, NHT before surgery significantly decreased PCRD. This effect appeared to be mainly driven by the early addition of RT post-surgery. The specific sequence of NHT+RP and adjuvant RT merits further study in the high-risk PCa population.

Long-term survival of patients aged 80 years or older treated with radical prostatectomy for prostate cancer.

BACKGROUND: Radical prostatectomy (RP) is the gold standard for clinically localized prostate cancer (PCa) patients with life expectancy (LE) of at least 10 years. We examined long-term survival of men aged 80 years or older treated with RP and we attempted to identify criteria based on age and comorbidities that could predict survival of at least 10 years after RP, to identify those that might be considered for RP. PATIENTS AND METHODS: In Surveillance Epidemiology and End Results (SEER)-Medicare-linked database, we identified 234 octo- and nonagenarians with clinical T1, T2 or T3 PCa treated with RP between 1991 and 2009. Kaplan-Meier analyses examined 10-year survival patterns. Multivariable Cox regression analyses focused on the combined effect of age and/or Charlson Comorbidity Index (CCI) after adjusting for different confounders. RESULTS: The 10-year overall survival (OS) and cancer specific mortality (CSM) rates in the overall population were 51 and 9.9%. In individuals aged 80-81 years old, the 10-year OS was 62.4 vs. 39.6% in older patients (p = 0.001). Moreover, combination of age 80-81 with CCI = 0 yielded 10-year OS of 67.9 vs. 28.5% in older and sicker patients (p < 0.001). Age 80-81, absence of comorbidities and the combination of age 80-81 with CCI = 0, represented independent predictors of lower overall mortality (all p ≤ 0.01). CONCLUSIONS: Two out of three individuals selected for RP aged 80-81 years and without comorbidities, fulfill the criterion of LE of 10 years or more. Therefore, elderly PCa individuals can be suitable for surgical management, if appropriately selected, based on LE criterion.

Prognostic value of the new Grade Groups in Prostate Cancer: a multi-institutional European validation study.

BACKGROUND: We aimed to assess the prognostic relevance of the new Grade Groups in Prostate Cancer (PCa) within a large cohort of European men treated with radical prostatectomy (RP). METHODS: Data from 27 122 patients treated with RP at seven European centers were analyzed. We investigated the prognostic performance of the new Grade Groups (based on Gleason score 3+3, 3+4, 4+3, 8 and 9-10) on biopsy and RP specimen, adjusted for established clinical and pathological characteristics. Multivariable Cox proportional hazards regression models assessed the association of new Grade Groups with biochemical recurrence (BCR). Prognostic accuracies of the models were assessed using Harrell's C-index. RESULTS: Median follow-up was 29 months (interquartile range, 13-54). The 4-year estimated BCR-free survival (bRFS) for biopsy Grade Groups 1-5 were 91.3, 81.6, 69.8, 60.3 and 44.4%, respectively. The 4-year estimated bRFS for RP Grade Groups 1-5 were 96.1%, 86.7%, 67.0%, 63.1% and 41.0%, respectively. Compared with Grade Group 1, all other Grade Groups based both on biopsy and RP specimen were independently associated with a lower bRFS (all P<0.01). Adjusted pairwise comparisons revealed statistically differences between all Grade Groups, except for group 3 and 4 on RP specimen (P=0.10). The discriminations of the multivariable base prognostic models based on the current three-tier and the new five-tier systems were not clinically different (0.3 and 0.9% increase in discrimination for clinical and pathological model). CONCLUSIONS: We validated the independent prognostic value of the new Grade Groups on biopsy and RP specimen from European PCa men. However, it does not improve the accuracies of prognostic models by a clinically significant margin. Nevertheless, this new classification may help physicians and patients estimate disease aggressiveness with a user-friendly, clinically relevant and reproducible method.