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.

[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.

[Active surveillance-much safety, little recruitment : Is it possible to extend the indication for "intermediate-risk" prostate cancer?] / Active Surveillance ­ viel Sicherheit, wenig Rekrutierung : Ist eine Ausdehnung der Indikation auf das intermediäre Risiko möglich?

BACKGROUND: In contrast to North America or Sweden, active surveillance (AS) has not yet become established in our country for suitable prostate carcinomas (PCa). The strict entry criteria specified by the guideline are not likely to improve the acceptance in the near future. In early detection, prostate-specific antigen (PSA) testing leads to high numbers of overtreatment. There are various reasons for the continued preference for radical surgery. OBJECTIVES: The goal is to examine whether the heterogeneous group with intermediate-risk PCa contains tumors that may be eligible for AS. MATERIALS AND METHODS: In the HAROW trial, 52 AS patients with differently defined intermediate-risk PCa were followed for a median of 85.6 months. Oncologic outcomes are reported. RESULTS: Sixteen (30%) patients had a tumor of cT2b category, 21 (40%) had a Gleason score 3 + 4, 7 (14%) had ≥3 positive biopsy cores, 21 (40%) had a PSA >10 ng/ml, and 22 (42%) had a PSA density >0.2 ng/ml2. Carcinoma-specific and metastasis-free survival were 100% and 96%, respectively. Thirty four patients discontinued AS in favor of invasive treatment, and an additional eight men maintained a noninvasive approach by switching to watchful waiting. CONCLUSIONS: Efforts are under way to specify the criteria for patients with intermediate-risk PCa who may be eligible for AS. Tumors of cT2 category could be grouped together. The Gleason 4 fraction needs to be quantified because it determines the prognosis.

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.

Treatment-Related Healthcare Costs of Metastatic Castration-Resistant Prostate Cancer in Germany: A Claims Data Study.

PURPOSE: Treatments for patients with metastatic castration-resistant prostate cancer (mCRPC) have expanded rapidly. They include the chemotherapies docetaxel and cabazitaxel, hormonal drugs abiraterone and enzalutamide, and best supportive care (BSC). Cabazitaxel has proven to be the last life-prolonging option, associated with a significant risk of serious adverse events. Given the lack of real-world evidence, we aimed to compare healthcare resource utilization (HRU) and costs in patients with mCRPC treated with cabazitaxel, docetaxel, abiraterone, enzalutamide, and BSC. METHODS: We used 2014-2017 claims data from a large German statutory health insurance fund, the Techniker Krankenkasse, to identify patients with mCRPC. Patient allocation to individual therapy regimens was based on clinical knowledge and included therapy cycles, duration of therapy, and continuous treatment. The study period lasted from the first claim until death, the end of data availability, a drug switch, or discontinuation of therapy, whichever came first. Multivariate regression models were used to compare monthly all-cause and mCRPC-related HRU and costs across cohorts by adjusting for baseline covariates (including age and comorbidities). RESULTS: The 3944 identified patients with mCRPC initiated treatment with cabazitaxel (n = 240), docetaxel (n = 539), abiraterone (n = 486), enzalutamide (n = 351), or BSC (n = 2328). In most domains, HRU was highest in the cabazitaxel cohort and lowest in the BSC group. Accordingly, the highest all-cause and mCRPC-related costs per month, respectively, were observed in patients receiving cabazitaxel (€7631/€6343), followed by abiraterone (€5226/€4579), enzalutamide (€5079/€4416), docetaxel (€2392/€1580), and BSC (€959/€438). Cost variations were mostly attributable to drugs, inpatient treatment, and sick leave payments. CONCLUSION: mCRPC treatment imposes a high economic burden on statutory health insurance. Cabazitaxel is associated with substantially higher expenses, resulting from higher drug costs and a greater need for inpatient treatment. As mCRPC continues to be incurable, decision makers and clinician leaders should carefully evaluate public access to innovative agents and optimal treatment strategies.

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.

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.

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.

[It is unclear whether pelvic lymphadenectomy is of oncological benefit in prostate cancer]. / Der onkologische Nutzen der pelvinen Lymphadenektomie ist beim Prostatakarzinom nicht geklärt.

Fossati's 2017 review questions the value of pelvic lymphadenectomy (pLA) in radical prostatectomy (RP) because available studies fail to show any oncological benefit. Our finding that no spread of metastatic lymph nodes (LN) has been demonstrated is based on registry data, clinical trials without evidence of pLA benefit and considerations of the genetic link between LN metastasis and distant metastases. The improved imaging with 68GaPSMA-PET-CT facilitates the detection of metastases and thus the omission of pLA as diagnostic intervention, thereby avoiding typical complications. The question whether pLA, or a multimodal treatment concept, might benefit intermediate and high-risk patients can only be answered by an RCT which, above all, must consider the incompletely removed primary as a source of metastatic spread.

[Noninvasive treatment of organ-confined prostate cancer in elderly patients-results of the HAROW study]. / Die nichtinvasive Therapie des organbegrenzten Prostatakarzinoms im Alter ­ Ergebnisse der HAROW-Studie.

BACKGROUND: Noninvasive treatment options such as active surveillance (AS), watchful waiting (WW), and hormone deprivation therapy (HT) are particularly important in elderly patients with localized prostate cancer (PCa). OBJECTIVES: We examine the use of these noninvasive treatment options in the everyday care in a cohort of patients ≥70 years old. MATERIALS AND METHODS: In the HAROW study, the treatment of localized PCa under everyday conditions is investigated. The only inclusion criterion was newly diagnosed organ-confined PCa (≤cT2c). In AS, WW, and HT patients, we compared initial tumor and patient characteristics, follow-up examinations and changes of therapy. RESULTS: Of 457 patients ≥70 years, 210 chose AS, 160 HT, and 87 WW. Observation times were 6.3 years (AS), 7.5 years (HT), and 7.0 years (WW). AS patients (73.2 years) were younger than WW (76.0 years) and HT patients (76.9 years) and had a higher proportion of low-risk tumors (80%) versus WW (31%) and HT (19%). A change of therapy was observed in 47.1% of AS, 17.2% of WW and 13.1% of HT patients. Metastasis occurred in 1.0% of AS, 4.6% of WW, and 6.9% of HT patients. Overall survival was 94.3% for AS, 90.8% for WW and 81.9% for HT. Within the first 28.4 months, the mean number of PSA determinations did not differ between AS and WW (6.1 vs. 5.2; p = 0.09); a rebiopsy was performed in 37.6% of AS, 11.4% of WW, and 17% of HT patients. CONCLUSIONS: The allocation to curative and palliative strategies should be made according to patient and tumor characteristics by definition. Palliative procedures may represent concepts in older patients who initially chose a curative AS strategy.

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.

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.

Is the Recommendation of a Pelvic Lymphadenectomy in Conjunction with Radical Prostatectomy in Prostate Cancer Patients Justified? Report from a Multidisciplinary Expert Panel Meeting.

INTRODUCTION: Pelvic lymphadenectomy (pLA) in prostate cancer (PCa) is one of the most common uro-oncologic surgical procedures. An increased complication rate is accompanied by unproven oncologic benefit. Extent of pLA and mechanisms of metastasis are discussed controversially. We aimed to explore evidence and knowledge gaps in pLA and mechanisms of metastasis in PCa and to develop further steps to clarify oncologic benefits through an expert panel. METHODS: A multidisciplinary expert meeting was initiated, compiling available facts on pLA and mechanisms of metastasis in PCa. Questions and hypotheses were formulated. The resulting protocol was modeled on priority and consistency in four anonymized voting rounds using the Delphi method (March 2018-June 2018). RESULTS: The oncologic benefit of pLA in PCa is still unclear. Results of randomized trials (RCTs) are pending. Extent and techniques of pLA are differently applied and inconsistently recommended by the guidelines as well as the indication for pLA. Different growth rates for the primaries and metastases and different survival curves for lymph node and organ metastasis at diagnosis argue against metastasis originating from positive nodes. However, results from clinical and basic research support this opportunity in PCa. CONCLUSIONS: The RCTs required to clarify the estimated low oncologic benefit of pLA prove to be difficult because of the great effort (e.g., high case number). Establishing a network of treatment centers for implementation of high-quality cohort studies could be an alternative approach. Future studies with larger panels and international participants based on the presented feasibility should be launched to set this process in motion. Until valid data are available, benefits and harms of pLA should be weighted under consideration of low-invasive techniques (e.g., sentinel pLA).

Prostate-specific health-related quality of life and patient-physician communication - A 3.5-year follow-up.

OBJECTIVE: The aim of this study is to examine associations between prostate-specific health-related quality of life (HRQOL) and aspects of patient-physician communication in localized prostate cancer treatment. METHODS: Data of patients with localized prostate cancer were collected at 6-month intervals over a 3.5-year period within a prospective, observational study (HAROW). Data collection comprised D'Amico risk categories, the Charlson Comorbidity Index, patient-physician communication (information, shared decision making, support, devotion), and prostate-specific HRQOL (incontinence aid, urinary symptoms, bowel symptoms, hormonal treatment-related symptoms, sexual functioning, sexual activity). Data of N = 1722 patients undergoing radical prostatectomy were analyzed by longitudinal multilevel analysis. RESULTS: The mean patient age was 65 years; 31% had a low risk and 38% an intermediate risk of cancer growth and spread; 73% had a Charlson Comorbidity Index of 0. Significant associations were found between prostate-specific HRQOL and shared decision making, support and devotion. Patient information was not significantly associated with aspects of prostate-specific HRQOL. CONCLUSION: Patient reported long term outcomes are associated with aspects of patient-physician communication in prostate cancer patients. Patients feeling involved by their urologists experience less side effects of (surgical) treatment. PRACTICE IMPLICATIONS: Special communication training programmes should be developed and implemented for urologists.

Predictive value of the UICC and AJCC 8th edition tumor-nodes-metastasis (TNM) classification for patients treated with radical prostatectomy.

BACKGROUND: According to the 8th-edition of the tumor-nodes-metastasis-classification localized prostate cancer (PCa) can be divided into two categories (cT1,cT2), two stages (SI,SII), and, by incorporating prostate-specific-antigen (PSA) and WHO-grade (Gleason-Score), into prognostic stage groups (PSG I,IIA,IIB,IIC,III). We examined the predictive value of these systems for an organ-confined disease (pT≤2), favorable WHO-grade ≤2 (Gleason-score ≤7a), and biochemical-free-survival (BFS) after radical prostatectomy (RP). METHODS: Data were collected in a prospective, non-interventional, multicenter health-service-research study for the treatment of localized PCa (HAROW) with 687 patients receiving RP. Mean Follow-up was 31.7 months. RESULTS: Organ-confined disease was present in 76.5% and 63.6% of cT1 and cT2 patients, 75.7% and 59.6% of SI and SII, and 84.6%, 81.6%, 72.8% and 42.5% of PSG I, IIA, IIB and ≥ IIC (p = 0.001). Favorable WHO-grade (Gleason-Score) was present in 75.4% and 60.7% of cT1 and cT2 patients, 74.3% and 56.5% of SI and SII patients, and 86.1%,85.6%,73.3% and 29.5% of PSG I, IIA, IIB and ≥ IIC (p = 0.001). Probability of BFS was 92.0% and 91.5% for cT1 and cT2 (p = 0.990), 91.1% and 94.2% for SI and S II (p = 0.286) and 96.6%,95.1%,91.4% and 78.8% for PSG I,IIA,IIB and ≥ IIC (p = 0.001). CONCLUSIONS: CT 1/cT2 and S I/II subgrouping is feasible to predict a different pT-category and a favorable WHO-grade (Gleason-Score) after RP, but failed to predict a different BFS. With the additional information of WHO-grade (Gleason-Score) and PSA, the PSG represents an approach for the prediction of all examined endpoints which is a useful tool to help clinicians to advise their patients.

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.