Safety and survival of docetaxel and cabazitaxel in metastatic castration-resistant prostate cancer.

OBJECTIVES: To investigate real-world haematological toxicity, overall survival (OS) and the treatment characteristics of docetaxel and cabazitaxel chemotherapy in metastatic castration-resistant prostate cancer (mCRPC). PATIENTS AND METHODS: This retrospective claims data study followed patients with mCRPC receiving cabazitaxel or docetaxel from their first chemotherapy infusion. Haematological toxicities were measured using treatment codes and inpatient diagnoses. OS was estimated using the Kaplan-Meier method. A multivariable Cox regression analysis was used to identify OS predictors. RESULTS: Data from 539 patients administered docetaxel and 240 administered cabazitaxel were analysed. Regarding adverse events, within 8 months of treatment initiation, some kind of treatment for haematological toxicity was documented in 31% of patients given docetaxel and in 61% of patients given cabazitaxel. In the same period, hospitalization associated with haematological toxicity was documented in 11% of the patients in the docetaxel cohort and in 15% of the patients in the cabazitaxel cohort. In the docetaxel cohort, 9.9% of patients required reverse isolation and 13% were diagnosed with sepsis during hospitalization. In the cabazitaxel cohort, the cumulative incidence was 7.9% and 15%, respectively. The median OS was reached at 21.9 months in the docetaxel cohort and, because of a later line of therapy, at 11.3 months in the cabazitaxel cohort. A multivariate Cox regression revealed that indicators of locally advanced and metastatic disease, severe comorbidities, and prior hormonal/cytotoxic therapies were independent predictors of early death. CONCLUSION: Cabazitaxel patients face an increased risk of haematological toxicities during treatment. Together with their short survival time, this calls for a strict indication when using cabazitaxel in patients with mCRPC.

Surgical Reintervention Rates after Invasive Treatment for Lower Urinary Tract Symptoms due to Benign Prostatic Syndrome: A Comparative Study of More than 43,000 Patients with Long-Term Followup.

PURPOSE: No large-scale comparison of the 4 most established surgical approaches for lower urinary tract symptoms due to benign prostate obstruction in terms of long-term efficacy is available. We compared photoselective vaporization, laser enucleation and open simple prostatectomy to transurethral resection with regard to 5-year surgical reintervention rates. MATERIALS AND METHODS: A total of 43,041 male patients with lower urinary tract symptoms who underwent transurethral resection (34,526), photoselective vaporization (3,050), laser enucleation (1,814) or open simple prostatectomy (3,651) between 2011 and 2013 were identified in pseudonymized claims and core data of the German local health care funds and followed for 5 years. Surgical reinterventions for lower urinary tract symptoms, urethral stricture or bladder neck contracture were evaluated. Surgical approach was related to reintervention risk using the Kaplan-Meier method and Cox proportional hazards models. RESULTS: A total of 5,050 first reinterventions were performed within 5 years of primary surgery (Kaplan-Meier survival without reintervention: 87.5%, 95% CI 87.2%-87.8%). Photoselective vaporization carried an increased hazard of reintervention (HR 1.31, 95% CI 1.17-1.46, p <0.001) relative to transurethral resection, open simple prostatectomy carried a lower hazard (HR 0.43, 95% CI 0.37-0.50, p <0.001) and laser enucleation of the prostate did not differ significantly (HR 0.84, 95% CI 0.66-1.08, p=0.2). This pattern was more pronounced regarding reintervention for lower urinary tract symptom recurrence (photoselective vaporization: HR 1.52, 95% CI 1.35-1.72, p <0.001; laser enucleation of the prostate: HR 0.84, 95% CI 0.63-1.14, p=0.3; open simply prostatectomy: HR 0.38, 95% CI 0.31-0.46, p <0.001 relative to transurethral resection). CONCLUSIONS: Five-year reintervention rates of transurethral resection and laser enucleation did not differ significantly, while photoselective vaporization had a substantially higher rate. Open simple prostatectomy remains superior to transurethral resection with respect to long-term efficacy.

Long-term outcomes of active surveillance for clinically localized prostate cancer in a community-based setting: results from a prospective non-interventional study.

PURPOSE: To report on long-term outcomes of patients treated with active surveillance (AS) for localized prostate cancer (PCa) in the daily routine setting. METHODS: HAROW (2008-2013) was a non-interventional, health service research study about the management of localized PCa in the community setting, with 86% of the study centers being office-based urologists. A follow-up examination of all patients who opted for AS as primary treatment was carried out. Overall, cancer-specific, and metastasis-free survival, as well as discontinuation rates, were determined. RESULTS: Of 329 patients, 62.9% had very-low- and 21.3% low-risk tumours. The median follow-up was 7.7 years (IQR 4.7-9.1). Twenty-eight patients (8.5%) died unrelated to PCa, of whom 19 were under AS or watchful waiting (WW). Additionally, seven patients (2.1%) developed metastasis. The estimated 10-year overall and metastasis-free survival was 86% (95% CI 81.7-90.3) and 97% (95% CI 94.6-99.3), respectively. One hundred eighty-seven patients (56.8%) discontinued AS changing to invasive treatment: 104 radical prostatectomies (RP), 55 radiotherapies (RT), and 28 hormonal treatments (HT). Another 50 patients switched to WW. Finally, 37.4% remained alive without invasive therapy (22.2% AS and 15.2% WW). Intervention-free survival differed between the risk groups: 47.8% in the very-low-, 33.8% in the low- and 34.6% in the intermediate-/high-risk-group (p = 0.008). On multivariable analysis, PSA-density ≥ 0.2 ng/ml2 was significantly predictive for receiving invasive treatment (HR 2.55; p = 0.001). CONCLUSION: Even in routine care, AS can be considered a safe treatment option. Our results might encourage office-based urologists regarding the implementation of AS and to counteract possible concerns against this treatment option.

Treatment of post-prostatectomy urinary incontinence and erectile dysfunction: there is insufficient utilisation of care in German cancer survivors.

PURPOSE: Treatment of post-prostatectomy urinary incontinence (UI) and erectile dysfunction (ED) increases quality of life (QoL). Aim of our study was to evaluate the utilisation of care among patients with post-prostatectomy UI and ED in Germany. METHODS: The HAROW study documented treatment of patients with localised prostate cancer (≤ T2c) in Germany. 1260 patients underwent radical prostatectomy (RP). Patients answered validated questionnaires after a median follow-up of 6.3 years. Response rate was 76.8%. RESULTS: Median age at RP was 65 (IQR 60-69) years. 14% (134/936) used more than one pad per day for UI. 25% (26/104, 30 missing) of UI patients underwent surgery to improve continence. Of patients without surgery, 41% (31/75) reported a moderate-to-severe issue concerning their incontinence with worse mental health and QoL. 81% (755/936) patients were unable to have an erection firm enough for sexual intercourse. Of all ED patients, 40% (319/793) used ED treatment regularly or tried it at least once. 49% (243/499) of patients with interest in sex never tried ED treatment. In multivariate analysis, patients not using ED treatments were older (≥ 70 years OR 4.1), and more often had preoperative ED (OR 2.3) and less interest in sex (OR 2.2). Nevertheless, 30% (73/240) of these patients had moderate-to-severe issues with their ED reporting worse mental health and QoL. CONCLUSION: Almost half of the patients without post-prostatectomy UI and ED treatment reported moderate-to-severe issues with a significant decrease in QoL. This indicates an insufficient utilisation of care in Germany.

Active Surveillance for Incidental (cT1a/b) Prostate Cancer: Long-Term Outcomes of the Prospective Noninterventional HAROW Study.

INTRODUCTION: Optimal treatment for incidental prostate cancer (IPC) after surgical treatment for benign prostate obstruction is still debatable. We report on long-term outcomes of IPC patients managed with active surveillance (AS) in a German multicenter study. METHODS: HAROW (2008-2013) was designed as a noninterventional, prospective, health-service research study for patients with localized prostate cancer (≤cT2), including patients with IPC (cT1a/b). A follow-up examination of all patients treated with AS was carried out. Overall, cancer-specific, and metastasis-free survival and discontinuation rates were determined. RESULTS: Of 210 IPC patients, 68 opted for AS and were available for evaluation. Fifty-four patients had cT1a category and 14 cT1b category. Median follow-up was 7.7 years (IQR: 5.7-9.1). Eight patients died of which 6 were still under AS or watchful waiting (WW). No PCa-specific death could be observed. One patient developed metastasis. Twenty-three patients (33.8%) discontinued AS changing to invasive treatment: 12 chose radical prostatectomy, 7 radiotherapy, and 4 hormonal treatment. Another 19 patients switched to WW. The Kaplan-Meier estimated 10-year overall, cancer-specific, metastasis-free, and intervention-free survival was 83.8% (95% CI: 72.2-95.3), 100%, 98.4% (95% CI: 95.3-99.9), and 61.0% (95% CI: 47.7-74.3), respectively. In multivariable analysis, age (RR: 0.97; p < 0.001), PSA density ≥0.2 ng/mL2 (RR: 13.23; p < 0.001), and PSA ≥1.0 ng/mL after surgery (RR: 5.19; p = 0.016) were significantly predictive for receiving an invasive treatment. CONCLUSION: In comparison with other AS series with a general low-risk prostate cancer population, our study confirmed the promising survival outcomes for IPC patients, whereas discontinuation rates seem to be lower for IPC. Thus, IPC patients at low risk of progression may be good candidates for AS.

Decision Regret after Radical Prostatectomy does Not Depend on Surgical Approach: 6-Year Followup of a Large German Cohort Undergoing Routine Care.

PURPOSE: Numerous studies have compared the outcomes of open and robot-assisted radical prostatectomy but to our knowledge only 1 study has focused on patient satisfaction and regret. We evaluated intermediate term decision regret after open and robot-assisted radical prostatectomy. MATERIALS AND METHODS: The HAROW (Hormonal Therapy, Active Surveillance, Radiation, Operation, Watchful Waiting) study analyzed localized prostate cancer treatments (T2c N0 M0 or less) in Germany from 2008 to 2013. We collected intermediate term followup data on 1,260 patients after retropubic open or robot-assisted radical prostatectomy. RESULTS: The response rate was 76.8% (936 of 1,218 cases). A total of 404 patients underwent robot-assisted radical prostatectomy and 532 underwent open radical prostatectomy. Patients treated with the robot-assisted procedure showed more self-determined behavior. They reported an active role in surgical decision making and the surgical approach (robot-assisted radical vs open prostatectomy 39% vs 24% and 52% vs 18%, respectively, each p <0.001). Patients treated with the robot-assisted procedure more often participated actively in selecting the treating hospital (25% vs 11%), used the Internet often (87% vs 72%) and traveled an increased distance (63 vs 42 km, all p <0.001). Overall decision regret was low with a mean ± SD score of 14 ± 19 on a scale of 0-no regret to 100-high regret. Multivariate analysis showed that erectile function (OR 3.2), urinary continence (OR 1.8), freedom from recurrence (OR 1.6), an active decision making role (OR 2.2) and shorter followup (OR 0.9 per year) predicted low decision regret (score less than 15). CONCLUSIONS: Intermediate term functional and oncologic outcomes as well as autonomous decision making and followup time influenced decision regret after radical prostatectomy. The surgical approach was not associated with intermediate term decision regret.

Long-term functional outcomes after robotic vs. retropubic radical prostatectomy in routine care: a 6-year follow-up of a large German health services research study.

PURPOSE: To compare long-term functional outcomes after robotic vs. retropubic RP for patients with localized prostate cancer in routine care. METHODS: "HAROW" was a large German noninterventional health services research study that prospectively evaluated the treatment of patients with localized prostate cancer (≤ T2c). We sent validated questionnaires to 1260 patients who underwent RP to evaluate long-term outcomes. RESULTS: After a median follow-up of 6.3 [interquartile range (IQR) 4.8-7.6] years, 42 (3%) patients had died. The return rate of the questionnaire was 76.8% (936/1218). The approach was robotic in 404 and retropubic in 532 patients. In the multivariate analysis, lack of postoperative radiotherapy [odds ratio (OR) 3.1], younger patient age (< 60 years: OR 2.8; 60-69 years: OR 2.1), preoperative urinary continence (OR 2.4), and higher annual hospital caseload (≥ 200 cases: OR 1.6) were independent predictors of urinary continence. The potency rate after nerve-sparing RP in preoperatively potent men was 40.5% (111/274). In the multivariate analysis, younger patient age (< 60 years: OR 17.9; 60-69 years: OR 8.0), lower oncologic risk (OR 2.8), and lack of postoperative radiotherapy (OR 2.2) were independent predictors of potency. CONCLUSION: Younger age and lack of postoperative radiotherapy were associated with better urinary continence and erectile function. Additionally, a high annual caseload (≥ 200 RP/year) was associated with better urinary continence. Younger age, low or intermediated oncological risk and lack of postoperative radiotherapy were independent predictors for a trifecta outcome. The surgical approach did not affect long-term functional outcomes.

Health-related quality of life in active surveillance and radical prostatectomy for low-risk prostate cancer: a prospective observational study (HAROW - Hormonal therapy, Active Surveillance, Radiation, Operation, Watchful Waiting).

OBJECTIVES: To compare health-related quality of life (HRQOL) between patients with localised prostate cancer in an active surveillance (AS) group and a radical prostatectomy (RP) group, as evidence shows that both groups have similar oncological outcomes. Thus, comparative findings on the patients' HRQOL are becoming even more important to allow for informed treatment decision-making. PATIENTS AND METHODS: The Hormonal therapy, Active Surveillance, Radiation, Operation, Watchful Waiting (HAROW) study is a prospective, observational study designed to collect data for different treatment options for newly diagnosed patients with localised prostate cancer under real-life conditions. At 6-month intervals, clinical data (D'Amico risk categories, Charlson Comorbidity Index) and HRQOL (European Organisation for Research and Treatment of Cancer quality of life questionnaire 30-item core questionnaire) were collected. Data were analysed by longitudinal multilevel analysis for patients with localised prostate cancer under AS and RP. RESULTS: Data from 961 patients (556 RP, 405 AS) were considered. The follow-up was 3.5 years (median 2 years). The results reveal significant, but not clinically relevant advantages for patients with low-risk prostate cancer managed with AS in contrast to RP concerning global HRQOL as well as role, emotional and social functioning over time, after controlling for age, comorbidities, and partnership status. In some, but not all HRQOL scales, RP patients start with a slightly lower HRQOL and recover up to the level of AS patients within 1-2 years after diagnosis. CONCLUSION: HRQOL is an important aspect in the decision-making and advising process for patients with prostate cancer. In many aspects of HRQOL, AS is associated with more favourable outcomes than RP within the first 1-2 years after diagnosis in our observational design, although the differences were not clinically significant. The result that HRQOL in AS patients is at least as high as in RP patients should be considered when advising patients about the different treatment options for low-risk localised prostate cancer.

Utilization of Active Surveillance and Watchful Waiting for localized prostate cancer in the daily practice.

PURPOSE: To analyze the utilization of Active Surveillance (AS) and Watchful Waiting (WW) in the daily routine setting, since both are non-invasive treatment options for localized prostate cancer (PCa), which are used in a curative (AS) or palliative (WW) setting. Since differentiation of both strategies is not always clear, patients were compared with respect to the inclusion criteria, frequency of follow-up examinations (Prostate Specific Antigen = PSA tests, rebiopsies), and initiation of a deferred treatment. METHODS: HAROW is a non-interventional, health-service research study on the management of localized PCa in the community setting. Of 3169 patients, prospectively enrolled from 2008 to 2013 with a mean follow-up of 28.2 months, 468 chose AS and 126 WW. Treating urologists reported clinical variables, information on therapy and clinical course of disease. RESULTS: AS patients were significantly younger and had more low-risk tumors. No differences were seen in the number of PSA tests during follow-up: mean number of PSA tests was 6.08 for AS- and 5.18 for WW patients, more than four PSA tests were reported in 63.9% AS- and 59.5% WW patients (p = 0.136). At least one re-biopsy was performed in 39.7% AS- and 9.5% WW patients (p < 0.001). Discontinuation rates were 23.9% (n = 112) for AS and 11.9% (n = 15) for WW. Most of the AS patients opted for a curative treatment (prostatectomy = 65, radiotherapy = 30), whereas 12 WW patients received a palliative hormone therapy and three patients received radiotherapy. CONCLUSIONS: Physicians seem to distinguish clearly between AS and WW in terms of inclusion criteria and deferred therapy, whereas this differentiation tends to become indistinct in terms of follow-up examinations.

Risk stratification: a tool to predict the course of active surveillance for localized prostate cancer?

OBJECTIVE: To investigate a cohort of patients undergoing active surveillance (AS) for localized prostate cancer (PCa) with regard to possible differences in discontinuation rates, subsequent therapies, reasons for intervention and pathological findings after deferred surgery after patient stratification into very-low-risk, low-risk and intermediate-/high-risk PCa groups. PATIENTS AND METHODS: The HAROW study was a non-interventional, observational, outcomes research study on the management of localized PCa in the community setting. A total of 468 patients were prospectively enrolled in the HAROW study, with a mean follow-up of 28.5 months. Treating urologists reported clinical variables, information on therapy and clinical course of disease at 6-month intervals. RESULTS: Of 468 patients under AS, 244 were stratified into very-low-risk, 142 into low-risk and 82 into intermediate-/high-risk groups. Of these patients, 112 discontinued AS. Discontinuation rates were 25.4% in the very-low-risk, 21.1% in the low-risk and 24.4% in the intermediate-/high-risk groups (P = 0.633). The main reasons for intervention were biopsy upgrade and/or prostate-specific antigen elevation in the very-low- and low-risk groups, and patient preference in the intermediate-/high-risk group (P < 0.05). No significant differences were found regarding subsequent therapies and pathological findings after deferred surgery. CONCLUSION: Our results show no differences in the outcome of risk-stratified patients in the specified risk groups managed with AS, while switching to an invasive treatment on the patient's request was more frequent in the intermediate-/high-risk group.

Patient-physician communication and health-related quality of life of patients with localised prostate cancer undergoing radical prostatectomy - a longitudinal multilevel analysis.

OBJECTIVES: To examine whether patient-physician communication is associated with health-related quality of life (HRQoL) in a sample of patients with localised prostate cancer undergoing radical prostatectomy (RP). PATIENTS AND METHODS: HAROW (Hormonal therapy, Active Surveillance, Radiation, Operation, Watchful Waiting) is a prospective, observational study designed to collect data of the different treatment options for newly diagnosed patients with localised prostate cancer under real-life conditions. At 6-months intervals, clinical data (D'Amico risk categories, Charlson comorbidity index), aspects of patient-provider communication (standardised psychosocial-care instrument for patients' assessment of communication; Cologne Patient Questionnaire), and HRQoL (European Organization for Research and Treatment of Cancer Quality of Life Questionnaire) were assessed. Data were analysed by longitudinal multilevel analysis. RESULTS: Completed questionnaires for 1772 patients undergoing a RP were analysed over a 3-year follow-up period. Patients rated the patient-provider communication generally high with slight variations over the course of treatment (3.2-3.8). The HRQoL of the patients varied substantial over time and between the reported subscales (global HRQoL 71.1-77.2; physical functioning 89.1-92.1; role functioning 81.0-88.1; emotional functioning 74.4-84.0; cognitive functioning 84.3-87.7; social functioning (77.7-84.0). The longitudinal multilevel models showed significant associations between patient-provider communication in terms of devotion, support and shared decision-making, and functional aspects of HRQoL. CONCLUSION: Patient-provider communication is a valuable resource to support patients with prostate cancer coping with the disease and to improve their HRQoL. Future interventions should be designed especially for urologists to enhance their awareness for the importance of communication and the relationship with their patients with prostate cancer for treatment outcomes.

Active surveillance in localized prostate cancer: comparison of incidental tumours (T1a/b) and tumours diagnosed by core needle biopsy (T1c/T2a): results from the HAROW study.

OBJECTIVE: To conduct a comparative prospective analysis of patients with incidental T1a/T1b prostate cancer (IPCa) and those with prostate cancer (PCa) diagnosed by core needle biopsy, treated by active surveillance (AS), with regard to inclusion criteria, progression and switch to deferred treatment. PATIENTS AND METHODS: The HAROW study is an observational outcomes research study on the management of localized PCa. Treating urologists reported clinical variables and information on therapy and clinical course of disease at 6-month intervals. With respect to therapy, only recommendations were made; the final decision on the therapeutic method rested with the treating physician. RESULTS: Out of 2 957 patients included in the HAROW study, 447 chose AS. The median follow-up was 28.3 months. T1a, T1b, T1c and T2a disease were diagnosed in 81, 18, 292 and 56 patients, respectively. Patients in the IPCa group had lower prostate-specific antigen (PSA) levels (4.2 vs 6.1 ng/mL) and more comorbidities than those diagnosed by core needle biospy. The IPCa group also had fewer re-biopsies (25.3 vs 43.2%) and fewer changes to invasive treatment (12.1 vs 25.9%). No significant differences were found with respect to the criteria for discontinuation, subsequent therapies and histological findings after radical prostatectomy. CONCLUSION: Urologists are highly inclined to use AS as a therapeutic option in IPCa. More patients with IPCa than those diagnosed after core needle biopsy continued on AS, which was also associated with the indication for a re-biopsy being less stringently observed.

HAROW: the first comprehensive prospective observational study comparing treatment options in localized prostate cancer.

PURPOSE: To collect data on primary treatment decision and follow-up in patients with diagnosed, histologically confirmed localized (T1a-T2c/N0/M0) prostate cancer (PCa) for up to 5 years in a prospective observational non-interventional study. METHODS: Patients were non-randomly allocated to one of the five treatment strategies: hormone therapy, active surveillance, radiation, operation, or watchful waiting. RESULTS: A total of 3169 patients were included by 259 participating sites; 2957 patients had at least one follow-up visit. 54.8 % of tumors at baseline were staged as T1c, 38 % as T2a-T2c, and 7.1 % as T1a or T1b (missing: 0.2 %). 38.9, 32.6 and 26.6 % of patients were classified as low risk, intermediate risk, and high risk according to d'Amico, respectively (missing: 1.8 %). 56.6 % of patients underwent prostatectomy as primary therapy, 16.4 % received radiation, 6.9 % HT, 15.8 and 4.3 % decided for AS or WW. Mean follow-up was 28.4 months. Progression rates were between 8.6 % (RT) and 33.1 % (AS). CONCLUSION: Whereas RP remains the main treatment option of localized PCa, active surveillance appears to become an accepted and selectively employed treatment option. Careful selection of patients is documented by the highest proportion of patients with low risk (82.5 %), PSA density <0.2 ng/ml/ml (77.5 %), T1 staging (83.6 %), Gleason score ≤6 (92.5 %), ≤2 positive biopsies (79.4 %), and lowest mean PSA (5.8 ng/ml) in the AS group. The relatively high progression rate in the AS group has to be considered in the context of treatment changes; 71/155 patients had a documented change of treatment and 62 of them with a follow-up period of >3 months.

National trends and differences in morbidity among surgical approaches for radical prostatectomy in Germany.

OBJECTIVE: In this study, we document trends in radical prostatectomy (RP) employment in Germany during the period 2005-2012 and compare the morbidity of open (ORP), laparoscopic and robotic-assisted RP based on nationwide administrative data of Allgemeine Ortskrankenkassen (AOK) German local healthcare funds. MATERIALS AND METHODS: Administrative claims data of all AOK patients subjected to RP during 2005-2012 (57,156 cases) were used to evaluate the employment of minimally invasive RP (MIRP) procedures, pelvic lymph node dissection (PLND) and nerve-sparing approaches during this period. In addition, data from the most recent three-year period of our dataset (2010-2012) were used to compare the morbidity among the different surgical approaches. Study end points comprised 30-day mortality, 30-day transfusion, 1-year reintervention and 30-day adverse events, as well as 1-year overall complications. RESULTS: A 20 % reduction in RP utilization from 2007 to 2012 was documented. ORP remained the predominant RP approach in Germany. MIRP approaches carried a lower risk of 30-day transfusions, 1-year reinterventions and 1-year overall complications than ORP when adjusting for confounding factors. PLND was associated with an increased risk of complications, while age in the highest quintile and the presence of comorbidities were independent risk factors for morbidity and mortality. Lack of pathological data was the main limitation of the study. CONCLUSIONS: RP utilization in Germany is dropping, but the use of MIRP has risen steadily during the years 2005-2012, which is expected to have a positive impact on the morbidity of the operation.

Treatment of Incidental Prostate Cancer by Active Surveillance: Results of the HAROW Study.

OBJECTIVE: To report on a cohort of patients with incidental prostate cancer (IPC) that was treated by an active surveillance (AS) protocol in the HAROW study. MATERIALS AND METHODS: The HAROW study is an observational study on the management of localized prostate cancer in Germany. Treating urologists were reporting clinical parameters, information on therapy and clinical course of disease at 6-month intervals. RESULTS: In total, 3,169 patients were enrolled. In 224 patients were found an IPC and 104 (46%) of them were put on an AS protocol. The mean follow-up was 26.5 months. Tumor progression was noted in 16 patients. In 11 patients, AS was replaced by a definite intervention. In univariate and multivariate analyses, only PSA density correlated with progression. CONCLUSION: This is the first prospective description of an IPC patient cohort on AS as part of an outcomes research study. AS was selected as a therapeutic strategy in nearly half of the patients (46%). Only a minor proportion (16%) displayed progression. Of the clinical parameters, only PSA density correlated with progression.

"We talk it over"--mixed-method study of interdisciplinary collaborations in private practice among urologists and oncologists in Germany.

BACKGROUND: Utilisation of multidisciplinary teams is considered the best approach to care and treatment for cancer patients. However, the multidisciplinary approach has mainly focused on inpatient care rather than routine outpatient care. The situation in private practice care and outpatient care is gradually changing. We aimed to 1), investigate interdisciplinary cooperations in the care of tumor patients among urologists and oncologists in the community setting, 2), establish an estimate of the prevalence of cooperation among oncologists and organ-specific providers in community settings in Germany and 3), characterise existing cooperations among oncologists and urologists. METHODS: We conducted simultaneously a cross-sectional survey with private practice urologists (n=1,925) and a qualitative study consisting of semi-structured interviews with urologists and oncologists (n=42), primarily with private practices, who had indicated cooperation the care of urological tumor patients. RESULTS: Most of the participants (66%) treated their own tumor patients. When physicians referred patients, they did so for co- and subsequent treatments (43%). Most cooperating urologists were satisfied with the partnership and appreciated the competency of their partners. Qualitative interviews revealed two types of collaboration in the community setting: formal and informal. Collaborations were usually ongoing with many physicians and depended equally on both patient preference and diagnosis. CONCLUSION: Joint patient treatment requires clear delineation of roles and responsibilities and simple means of communication. Formal frameworks should allow for incorporation of patients' critical role in collaboration decisions in treatment and care.

A comparative assessment of active surveillance for localized prostate cancer in the community versus tertiary care referral center.

OBJECTIVES: To date, evidence on active surveillance (AS) is restricted to protocol-based studies. Conversely, practice patterns outside of such protocols are unknown. The aim of this study was to capture the current AS treatment patterns for localized prostate cancer in patients managed by office-based urologists compared to patients treated at a tertiary care center. METHODS AND MATERIALS: Two prospective cohorts were investigated: 361 AS arm patients of the German Hormonal treatment, Active surveillance, Radiation therapy, OP, Watchful waiting (HAROW) study, an observational health service study and 387 protocol-based AS patients treated at the Department of Urology of the Kantonsspital Aarau, Switzerland were included. Observational non-protocol HAROW versus on-protocol Kantonsspital Aarau (KSA) was compared, and active-treatment-free survival represented the primary outcome. RESULTS: Study population of the observational HAROW versus tertiary care protocol-based KSA cohorts differed statistically significantly regarding age (p < 0.001) and proportion of patients meeting the Chism criteria (p < 0.001). In stratified analyses, AFTS at 1 and 2 years was, respectively, 87.7 % (95 % CI 84.0-91.7) and 75.0 % (95 % CI 69.7-80.8) in HAROW patients compared to 90.8 % (95 % CI 87.8-93.9) and 75.3 % (95 % CI 70.7-80.1) for patients in the KSA cohort (p = 0.97). CONCLUSION: We demonstrate significant differences in terms of AS inclusion, surveillance and discontinuation criteria between patients managed by office-based urologists compared to their tertiary care counterparts. Interestingly, the risk of deferred active therapy was equally moderate for both groups in the short-term follow-up.

A longitudinal study of changes in provider-patient interaction in treatment of localized prostate cancer.

PURPOSE: Whilst much is known as to the met and unmet communication needs of prostate cancer patients, few studies have been conducted on the changes in communication between provider and patient over time. Therefore, the aim of our study is to examine (a) whether there are changes over time in the quality of psychosocial care in long-term treatment of localized prostate cancer and (b) whether those changes are associated with the treatment decision. METHODS: HAROW is a prospective, observational study designed to collect clinical data and patient reported outcomes (PROs) of different treatment options (hormonal therapy, active surveillance, radiation, operation, watchful waiting) for newly diagnosed patients with localized prostate cancer under real conditions. At 6-month intervals, general clinical data, PROs (e.g. quality of life, quality of physician-patient interaction) and individual costs are documented. We analysed data of N = 1,216 patients at the time of initial diagnosis (T1) and after 6 months (T2). RESULTS: There is a significant decline in shared decision-making behaviour of physicians for the group of patients undergoing a prostatectomy and for the hormonal therapy group at the time of initial diagnosis and after 6 months. In terms of emotional support by physicians, there is a significant difference between the treatment groups at the time of initial diagnosis with patients undergoing a prostatectomy reporting significantly less support than the hormonal therapy group. CONCLUSION: Future research from both, the providers' and the patients' perspective, will have to clarify if we can interpret our results as change in the communication behaviour once the treatment decision for prostatectomy or hormonal therapy is made.

[Gender-Sensitive Depression Screening (GSDS) - Further Validation of a New Self-Rating Instrument]. / Gendersensitives Depressionsscreening (GSDS) ­ Befunde zur weiteren Validierung eines neuen Selbstbeurteilungsinstruments.

OBJECTIVE: To check the validity of the preliminary results with the Gender-Sensitive Depression Screening (GSDS) in two German samples of non-psychiatric outpatients. METHODS: The psychometric validation of the GSDS-33 was performed in a sample of non-psychiatric outpatients of different clinics belonging to the Ludwig-Maximilians-University of Munich (n = 958) and in a male non-psychiatric sample of the Men's Health Center in Berlin (n = 237). RESULTS: Findings of the first validation study of the GSDS (Möller-Leimkühler, Mühleck 2020) were largely confirmed. The data also confirmed the factors 'aggressiveness' and 'emotional control' as important components of an increasing depression risk. Compared to a standard screening the GSDS again identified more risk cases among men in the two samples (8 % and 18 %). CONCLUSIONS: The GSDS-25 is a multidimensional, valid and reliable scale for better identifying men with a risk of depression.