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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/ml 2 . 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., (© 2021. Springer Medizin Verlag GmbH, ein Teil von Springer Nature.)

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.

Background: Treatment of localized low-risk prostate cancer (PCa) is undergoing a paradigm shift: Invasive treatments such as surgery and radiation therapy are being replaced by defensive strategies such as active surveillance (AS) and watchful waiting (WW)., Objective: The aim of this work is to evaluate the significance of current studies regarding defensive strategies (AS and WW)., Methods: The best-known AS studies are critically evaluated for their significance in terms of input criteria, follow-up criteria, and statistical significance., Results: The difficulties faced by randomized studies in answering the question of the best treatment for low-risk cancer in two or even more study groups with known low tumor-specific mortality are clearly shown. Some studies fail because of the objective, others-like PIVOT-are underpowered. ProtecT, a renowned randomized, controlled trial (RCT), lists systematic and statistical shortcomings in detail., Conclusion: The time and effort required for RCTs to answer the question of which therapy is best for locally limited low-risk cancer is very large because the low specific mortality rate requires a large number of participants and a long study duration. In any case, RCTs create hand-picked cohorts for statistical evaluation that have little to do with care in daily clinical practice. The necessary randomization is also offset by the decision-making of the informed patient. If further studies of low-risk PCa are needed, they will need real-world conditions that an RCT can not provide. To obtain clinically relevant results, we need to rethink things: When planning the study, biometricians and clinicians must understand that the statistical methods used in RCTs are of limited use and they must select a method (e.g. propensity scores) appropriate for health care research.

Background: The TNM staging system for localized prostate cancer (PCa) divides tumors based on clinical parameters into a clinical (c)T category and, after radical prostatectomy (RP), a pathological (p)T category., Objectives: This study examines the extent to which the cT and the pT category correspond to each other and whether the two categories differ in their prediction for organ-confined disease., Patients and Methods: Data of 687 RP patients were collected in a prospective, noninterventional, multicenter health service research study for the treatment of localized PCa (HAROW). Group comparisons were performed by analysis of variance and student t‑test as well as the chi-squared test or the Fisher exact test., Results: Clinical cT1 category (62.9%) and pathological pT2c category (56.6%) were diagnosed most frequently. The correspondence of cT and pT category was 15% for cT2a , 10.5% for cT2b, and 55% for cT2c. An extraprostatic extension (≥pT3) was observed for the categories cT1 and cT2 in 23.5% and 36.4% (p < 0.001), differences in the subcategories cT2a-c were not significant: cT2a = 28.8%, cT2b = 42.1%, and cT2c = 38.8% (p = 0.194). Tumors with a pathologically extraprostatic extension were not recognized clinically in >50%., Conclusions: For localized PCa there is low agreement between clinical and pathologic T category, thus, often leading to understaging. An adaptation of the T classification of the TNM system with division into "not palpable" and "palpable" appears sufficient for a prognostic prediction.

Background: Prostate cancer (PCa) is the most common cancer in men. For medical treatment of PCa, a number of therapies are available. The economic consequences associated with these individual treatment options in routine care in Germany are unclear so far., Methods: The present analysis was based on the Germany-wide HAROW observational study, which was conducted from 2008-2013. During this study, all participating physicians and involved patients reported and documented individual health care resource consumption. These data were evaluated in monetary terms stratified by treatment regime (hormone therapy, HT; active surveillance, AS; radiotherapy, RT; radical prostatectomy, RP; watchful waiting, WW)., Results: Overall, the data of 2672 patients were available for analysis. Based on the observational study design, the included patient groups were heterogeneous in their baseline characteristics. The annual total costs from the societal perspective were the largest for patient undergoing RP (9254 €; 95 % CI 8353-10,154), mainly driven by the costs for the initial hospital stay for surgery. HT, AS, RT, and WW seem to be comparable in terms of direct costs, ranging from 805 € (95 % CI 154-1455) for WW up to 1115 € (95 % CI 826-1405) for RT. The highest indirect costs were observed for patients receiving RT (3928 €; 95 % CI 0-10,675), which can be justified by the frequent incapacity to work in this patient group., Conclusion: The treatment of prostate cancer can lead to significant economic follow-up costs which vary greatly depending on the type of treatment. The analysis indicates a need for the implementation of a long-term health economic study in the future, which will be more suitable to show treatment-specific differences in the temporal occurrence of costs.

Background: Increasing life expectancy means growing numbers of elderly survive the critical age for cardiac and vascular diseases only to later experience cancer and dementia., Objectives: Of the types of cancer affecting men, prostate cancer continues to be diagnosed early by prostate-specific antigen (PSA) screening. The clinical relevance and quality of life of those affected must be critically judged. Depending on life expectancy, active surveillance (AS) and watchful waiting (WW) will be increasingly used in geriatric patients. Risk stratification as guided by CGA facilitates the therapeutic decisions of urologists and spares metastatic castration-resistant prostate cancer patients from unnecessary and adverse overtreatment. By 2030, approximately 1.8 million people will have dementia., Conclusions: Thus, in the future, the health care system will have to treat an aging population, which will require the creation of increasing numbers of geriatric hospital departments and cooperative models between geriatrics and other specialties. The future training of medical students and continuing medical education must also be further developed to include aspects on aging. Only in this manner will it be possible to effectively confront the challenges associated with demographic change in the specialty of geriatrics.

Background: Sexuality in the elderly is still a social taboo. A commitment by medical practices to address the topic of sexuality in later life is essential, given that the sexual health is part of the quality of life., Objectives: Identification of barriers and discourse of effects in the physician's behavior when dealing with the sexuality of older people., Materials and Methods: Review and discussion of interdisciplinary literature and social discourse. Compilation of expert opinions., Results: Although the introduction of phosphodiesterase 5 inhibitors led to a removal of taboos concerning erectile dysfunction, the sexuality of older men became narrowed to physiological aspects. The elderly still complain that consultations concerning their sexuality receives too little attention in medical practice. Problems are boundaries of shame and disregard of the sexuality of elderly., Conclusions: Sexuality in old age will have to become more prominent in medical practices, due to demographic changes and changing self-images of the elderly. The social role of physicians enables straightforward discussions about sexuality. Taking a sexual history and choosing an active approach proved to be practicable to discuss sexual problems with older people.

Background: To date, evidence on active surveillance (AS) is restricted to protocol-based studies and the current practice pattern outside medical centers is unknown., Objectives: The goal of this work was to capture the current treatment pattern of AS for localized prostate cancer (PCa) in patients managed by office-based urologists in Germany., Materials and Methods: Our cohort consisted of 361 patients included in the AS arm of the HAROW (Hormonal Treatment, Active Surveillance, Radiation Therapy, OP, Watchful Waiting) study, an observational health service study in Germany. Descriptive characteristics and active-treatment-free survival (ATFS), surgical outcomes, and triggers for active treatment were assessed., Results: Currently, only 15% of all patients with localized PCa were treated with AS. At baseline, 83% and 58% of all AS patients met the Chism and PRIAS low-risk criteria, respectively. After a median follow-up of 24 months, no systemic progression was observed, 5 patients died of non-disease-specific causes and active treatment was delivered in 20.5% of all patients. Triggers for active therapy were progression at biopsy (42%), rise in prostate-specific antigen level (27%), medical advice (16%) and patient's preference (10%), respectively., Conclusion: Our short-term results indicate that - in the hands of office-based urologists - active surveillance might represent a feasible treatment option for patients with localized PCa. The majority of patients were free of active treatment 2 years after AS initiation. Generally accepted inclusion and progression criteria are lacking and should be developed in order to facilitate and standardize AS in patients with low-risk PCa.

Background: The HAROW study was initiated to investigate the provision of ongoing medical care for patients with localized prostate cancer in a prospective, noninterventional setting and to investigate treatment options (Hormonal treatment, Active surveillance, Radiotherapy, Operation, Watchful waiting) under real-life conditions., Materials and Methods: A total of 3169 patients were enrolled by 259 participating physicians in private practice in Germany. The median follow-up was 28.4 months. At 6-month intervals, the treating physicians reported data on clinical parameters, clinical course of disease, and quality of patient-physician interaction., Results: The highest proportion of patients with low risk tumor was found in the defensive treatment groups (AS and WW). As expected, the AS group showed the highest progression rate. In all, 112 AS patients (23.9%) changed therapeutic strategy, 21 of them upon medical advice in the absence of any signs of progression. Metastases were seen most frequently in the WW group (1.5%). No metastases occurred in AS patients. Medical support in managing the disease reached high scores in all groups, the highest in AS., Conclusion: The data enable a differentiated comparative analysis of patient and tumor characteristics of each treatment group. Indication of AS was predominantly consistent with the guideline. The high rate of AS termination based on the physician's recommendation rather than on clinical progression is remarkable, and may be interpreted as a kind of insecurity in dealing with AS. Results regarding communication indicate that patients appreciated being involved in treatment decisions.

Introduction: Some data exist on information and decision-making preferences of elderly prostate cancer patients but little is known about whether communication needs are being met in urological practice. Therefore, it was the aim of this study to examine the information and shared decision-making experiences of prostate cancer patients over 75 years old., Materials and Methods: The HAROW (hormonal therapy, active surveillance, radiation, operation and watchful waiting) study is a prospective, observational study designed to collect clinical data and patient reported outcome of different treatment options for patients newly diagnosed 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. Data from 2,482 patients at 4 time points from T0 (initial diagnosis) to T3 (24 months follow-up) were analyzed., Results: T-tests and χ(2)-tests revealed no significant differences in terms of shared decision-making and information to different treatment options between patients aged over 75 years old and the rest of the sample. Regarding information on self-help groups, rehabilitation options and a second medical opinion, there were significant differences between prostate cancer patient age groups: patients aged over 75 years old received less information on these aspects at all points in time., Conclusion: Patients at all ages feel activated by urologists and are informed about different treatment options. However, there is room for improvement in terms of informing especially elderly prostate cancer patients about rehabilitation, second medical opinions and self-help groups. Special information tools and decision aids for prostate cancer patients aged over 75 years old should be developed and implemented to meet the specific information needs.

From the medical viewpoint (oncology agreement) and also from that of patients (self-help groups) urological competence should be increased and the cooperation between medical disciplines should be improved. What does the medical cooperation really look like? The few studies which have been carried out concern the cooperation between general physicians and specialists although specialists, such as urologists and hemato-oncologists have not yet been investigated. These gaps should be closed by the study of interdisciplinary treatment of urological tumors (IBuTu study).

Background: It is challenging to decide in which way we should care for localized prostate cancer. The current guideline can be accepted as an appropriate foundation. However, there are doubts if guideline recommendations are implemented., Results: The presented opinion survey of prostate cancer support groups shows that we have too many prostatectomies in senior patients. It reveals deficiencies in the guidance of the patients. They are not sufficiently embedded in the process of decision-making. More attention should be paid to initiatives of patient support groups.

Background: Due to rapidly developing knowledge guidelines should be regularly, i.e. annually, checked for validity and amended., Methods: Exemplified by the S3 guidelines on prostate cancer a contradiction between the need for updating and financial resources can be seen. Because the participating experts have only limited availability, the hurdles in the application procedure linked to bureaucracy should at least be dropped., Results: In the living guidelines on prostate cancer key questions on 13 updating and 5 primary points in question have been formulated and resolved. Examples of updating are imaging, active surveillance and high-intensity focused ultrasound and for primary points, the benefits of new markers and the results of proton therapy. The work, supported by other disciplines, the ÄZQ (Medical Center for Quality in Medicine) and the BPS (Federal Association of Prostate Self-help) should be finished by September 2011.

Early detection based on prostate-specific antigen (PSA) presumably can reduce prostate cancer mortality. At the same time it is associated with a comparatively high rate of overdiagnosis involving tumors that would not have become apparent without screening since they would have remained asymptomatic during the patient's entire life. Current studies show that the probability of such an overdiagnosis is 12-48 times higher than one which would save a man's life. Thus, overdiagnosis poses an ethical dilemma for physicians: their actions (screening examination) can turn a healthy individual into a chronically ill person. This profoundly contradicts the principle of medical ethics to"do no harm." An open debate on whether early detection can be reconciled with doctors' ethical duties is hampered by the implications of liability law, faulty economic incentives, and the pressures of competition as well as the empirical practice of many physicians to overestimate the benefits of cancer screening.

Background: The HAROW project was founded by the Stiftung Männergesundheit to have a closer look at the situation of patients who suffer from prostate cancer, especially focusing on their situation regarding supply and services., Methods: In the current study 504 members of support groups were asked about their health-related quality of life (QOL). Standardized questionnaires were used to ensure the validation. Both the diagnosis and initial therapy dated back at least 12 months. The EORTC QLQ-C30 as well as the prostate-specific module (PSM) were used as questionnaires., Results: Various forms of therapies proved to have different impacts on QOL. Patients with a combined hormonal therapy and radiation therapy evaluated their QOL worse than others with different forms of therapies. Patients with cured tumors reported significantly better data than those in the middle of therapy or the uncured., Conclusion: The data even indicate that their QOL is similar to people living under normal circumstances and health situations. Particular characteristics however exist on specific scales. Patients attending support groups show surprisingly high values for QOL.

Early detection based on measurement of the prostate-specific antigen (PSA) has resulted in more cases of prostate cancer being discovered that would have remained unnoticed without screening. Against this background, defensive strategies gain in importance. The current S3 guideline takes this development into account by recommending "active surveillance" (AS) and "watchful waiting" (WW) as equally accepted treatment options for localized prostate cancer. The available data concerning AS, on which the guideline recommendations rely, indicate that it is a safe treatment option for a well-defined patient cohort with low-risk tumors. Nevertheless, defensive strategies are regarded with considerable reservation in clinical practice, although curative measures in patients with low-risk tumors are of little therapeutic value.

Background: Guidelines are developed to improve the quality of patient care. The effect of German urologic guidelines has not been evaluated so far. Therefore, we aimed to systematically investigate the acceptance, use, and quality of the published guidelines from a user's perspective., Methods: A link to an online questionnaire concerning use and barriers to the application of guidelines was distributed via e-mail by the German Society of Urology (DGU). German urologists' opinions on differences in national guideline quality were evaluated regarding prostate cancer (PCA), bladder cancer, germ cell tumors (GCT), renal cell carcinomas, and erectile dysfunction., Results: Four hundred sixty-seven German urologists participated. More than 90% of the participants considered guidelines to be helpful. The Internet as the main tool for guideline distribution was favored by 28.4%, followed by publication in Urologe A. The main barrier to guideline usage was attributed to the lack of up-to date clinical data. Guidelines for GCT scored best in all quality categories and reached the highest level of use (65.8%), and 40.5% of participating urologists considered the additional establishment of comprehensive care centers for GCT as more effective for quality improvement than guideline development alone. For the other urologic tumors, especially PCA, guideline development was favored as a tool for quality improvement., Conclusion: More than 90% of participating urologists accept clinical guidelines as useful instruments in clinical practice and for therapeutic decisions. Our results should be integrated into guideline dissemination and implementation strategies in order to achieve a higher degree of treatment conformation to guidelines.

More and more localized prostate cancers with only a low risk for progression are diagnosed. In most cases the treatment consists of invasive procedures which may be accompanied by certain side effects. Ongoing randomized studies which are comparing irradiation and surgery with defensive strategies like Active Surveillance will not give results in the foreseeable future. In this situation it could be helpful to take data from health care research studies like HAROW. Neither the physicians nor the patients participating are selected. As a non-interventional study HAROW provides a data collecting in invasive therapies and in defensive strategies. Under everyday conditions data on cancer history, quality of life, patients' satisfaction and economics are collected. Since Active Surveillance (AS) is still a largely uncommon strategy we present criteria for enrollment, ongoing and termination. In international guidelines AS is assessed to be on a par with invasive procedures or even as the preferred treatment option.

Objective: As 30% of non-seminomas in clinical stage I will progress during active surveillance, alternative adjuvant strategies of 2 cycles of bleomycin, etoposid, cisplatin (BEP) or nerve sparing retroperitoneal lymphadenectomy (RPLND) can be offered. The risk of relapse is reduced to 2% and 10%, respectively. Without prognostic markers and with lowered toxicity it is postulated that only one cycle of BEP could significantly reduce the recurrence rate in comparison to RPLND., Materials and Methods: Between 1996 and 2005, 382 patients were randomly assigned to receive either RPLND (n=191) or 1 cycle of BEP (n=191). In accordance with the protocol, 174 patients were treated with 1 cycle of BEP and 173 underwent RPLND. The primary study end-point was a reduction of recurrence from 10% after RPLND to a maximum of 3% after 1 cycle of BEP., Results: After a mean follow-up of 4.7 years, there were 2 and 13 recurrences in the according-to-protocol population with chemotherapy and surgery, respectively. The difference between chemotherapy (1.15%) and surgery (7.5%) was statistically significant (p=0.0033). The tumor-specific survival was 100%., Conclusion: This largest randomized trial investigating treatment strategies in clinical stage I non-seminomas (AUO AH 01/94) showed the superiority of one cycle BEP over RPLND. The data obtained represent the basis for a reduced chemotherapy.

To improve quality of care, since 1989 the German Testicular Cancer Study Group (GTCSG) has published a series of guidelines on testicular germ cell cancer. These guidelines were updated in the 2007 publication"European Consensus on Diagnosis and Treatment of Germ Cell Cancer" (ECDTGCC). As an additional approach to improve the quality of care, the GTCSG established a national second-opinion system in 2006. The objective of this article is to summarise the present results, particularly regarding the interdependence between the guidelines and the second-opinion system.Data was exchanged between urologists and the second-opinion centres (SOCs) via the Internet. Data sets included the clinical primary data after orchiectomy, the intended therapy, the SOC's therapy recommendation, and the follow-up. The SOCs were 18 clinics that had qualified themselves through their participation in developing the ECDTGCC.From February 2006 to September 2008, 642 second opinions were requested. The discrepancy between the urologists' intended therapy and the SOCs' recommendations was 32.3%. The deviating second opinion in 40.3% (26.5%) of cases prevented overtreatment or undertreatment.Published guidelines are applied only sporadically. The results of the SOC system show that on the basis of this system, guidelines can be better implemented; in turn, the discrepancy between evidence-based guidelines and the actual treatment administered can be diminished.

Benign lesions of the testicles (stromal tumors, dermoid and epidermoid cysts as well as teratomas) are excised with the objective of preserving spermiogenesis and hormone production even though both testicles are present. If palpation, sonography and markers suggest a malignant tumor and the contralateral organ is affected by disease or has been ablated because of previous disease history, then enucleation resection is justified when the preoperative levels of plasma testosterone and LH are within the normal range. Postoperative irradiation of the unavoidable testicular intraepithelial neoplasia (TIN) with 20 Gy ensures the well-documented good results. If a child is desired, irradiation can be postponed with careful monitoring until pregnancy has ensued. Accurate indication and sophisticated technology result in a superiority of enucleation resection in comparison to non-surgical procedures (HIFU, chemotherapy, and irradiation for seminoma).

Of visitors to the Men's Health Awareness Days (Männergesundheitstage) in different German cities, 2,200 were asked to answer a standardised questionnaire about the quality of the information presented. Fifty-one per cent of the visitors answered; of those 80% gave mainly positive feedback, especially for a walk-through prostate model and for the presentations and discussions. Visitors represented only partial groups concerning age (64 years on average), existing prostate disease (51%), and participation in examinations for early detection (cancer screening). Therefore, many of the visitors did not represent the target group (healthy and under 60 years old). Qualified urologists could make better use of consultations by informing patients about local or general information events such as these. As men are burdened with multiple health risks, future Health Days should make use of interdisciplinary schemes.

In cases of germ cell tumors, urologists cooperate with oncologists to determine the best timing for high-dose chemotherapy (HDC). In the primary treatment of patients with"intermediate" and"poor" prognosis, HDC conveys no benefit. These patients are treated with four cycles of cisplatin, etoposide, and bleomycin (BEP). After failure of the standard therapy again four cycles of conventional-dose combination chemotherapy are necessary in good prognosis patients: cisplatin, ifosfamide and either etoposide (VIP or PEI), vinblastine (VeIP) or paclitaxel (TIP). HDC should be considered in patients who fail primary treatment, and who show unfavorable prognostic features prior to salvage treatment.

The diagnostic algorithm in cases of suspected bone metastases of genitourinary tumors still starts with a scintigraphic examination. Osseous metastases of hormone-refractory prostate cancer require treatment with zoledronic acid. A potential indication is a hormone-sensitive status. Nephrotoxic substances should not be administered simultaneously. To avoid osteonecrosis of the jaw, prior dental examination, oral hygiene, and if necessary dental reconstruction are recommended. Bisphosphonates can be combined with radiation therapy and chemotherapy; additional administration of calcium and vitamin D is not mandatory. It is recommended that patients with bone metastases of renal cell cancer be treated with bisphosphonates approved for this indication. For urothelial carcinoma and other genitourinary tumors, the available data are not sufficient to give a recommendation.

In 2002, with its "Off-label verdict", the German Federal Social Court (Bundessozialgericht; BSG) issued a fundamental decision to the effect that in certain circumstances an off-label prescription might be payable by health insurance firms, these circumstances being: severe illness with no prospect of a cure being brought about by any therapy approved for this illness and an evidence-based chance that an off-label treatment could yield a cure. Subsequently, the former German Federal Ministry of Health and Social Security (BMGS) appointed its "expert group on off-label use of treatments". This panel's task was to formulate professional comments and expert recommendations to the Federal Joint Committee (G-BA) on scientific evidence relating to selected medications used for off-label treatment. The group was found not to be sufficiently efficient and was laid down in August 2005. Meanwhile, it has been replaced by other work groups. However, the constant increase in the amount of medical evidence available means that off-label use is a continuing process that cannot easily be regulated by expert committees. It would be preferable for reimbursement for off-label prescriptions to be linked to the qualifications of the attendant physician. One suggestion might be that only specifically authorised physicians with special additional skills be permitted to apply and be reimbursed for off-label prescriptions.

According to estimations of the German Cancer Research Center in Heidelberg, the management of germ cell tumors in Germany is characterized by a marked difference between the actual mortality and the mortality to be expected with adequate implementation of the therapy standard. Our aim is to reduce the mortality rate by introducing a treatment procedure supported by a second opinion center.

There are about 345,000 Germans who have been diagnosed with urological cancer over the last 5 years expecting help from the health services. Even if aftercare is now a substantial part of cancer treatment, its effectiveness has been proven for only a few cancer types. For the subset of urological cancers, evidence for effective diagnostic measures in the framework of aftercare exists only for cancers of the bladder and testis. In this case, the main objective is early detection of local recurrences and providing a curative chance for small cancers. Lack of effectiveness may result from the logic of cancer itself, and is not the consequence of insufficient study designs. Therefore, the main task of aftercare is talking to the patient, to determine individual needs and to recognise treatment consequences. For asymptomatic patients, there is no indication for routine aftercare diagnostics.

To determine the effect of long-term storage on cryopreserved human sperm, 238 individual samples from 34 cryopreserved sperm deposits that had been collected between 1976 and 1989 were evaluated at regular intervals. The material was from 34 patients, 18 of whom suffered from underlying malignant disease. Every 3 years a sample from each deposit was thawed for microscopic analysis. During the course of the storage period limited to a maximum of 21 years, all ejaculate parameters had deteriorated in comparison to fresh semen. Quantitative motility was the most sensitive parameter with a decrease of ca. 80%. Sperm density decreased hardly at all. The parameters of the criteria investigated did not decrease linearly or proportionally with the storage duration, but rather more directly after the freezing process or within the first 3 years. These changes became increasingly smaller as the storage time lengthened. Almost all of the deposits exhibited adequate quality at all times during storage. Consequently, 21-year permanent frozen storage in liquid nitrogen is safe regarding aspects of spermatology.

The role of lymph node dissection in renal cell carcinoma has been controversial for decades. However, the results of the only prospective randomised study concerning this issue (EORTC 30881) are preliminary. Retrospective analyses were not able to demonstrate a diagnostic or therapeutic benefit of an extended lymph node dissection. Suspicious lymph nodes (imaging, palpation) should be excised during nephrectomy.

Of 405 patients with stage IV transitional cell carcinoma from an international multicenter phase III trial, 70 were randomized in Germany to receive either gemcitabine/cisplatin or standard MVAC systemic chemotherapy for locally advanced or metastatic urothelial cancer. Overall survival as the primary endpoint of the study was similar in both arms (median survival GC 15.4 months vs MVAC 16.1 months), as were tumor-specific survival and time to progressive disease. In the intent-to-treat analysis, the 5-year overall survival rate was 10% for patients randomized to GC and 18% randomized to MVAC. Tumor overall response rates (GC 54%, MVAC 53%) were similar. The toxic death rate was 0% in the GC arm and 3% (one patient) in the MVAC arm. Significantly more GC than MVAC patients experienced grade 3/4 anemia (GC 52%, MVAC 20%) with significantly more red blood cell transfusions in the GC arm.Significantly more GC than MVAC patients had grade 3/4 thrombocytopenia (GC 54%, MVAC 17%) without grade 3/4 hemorrhage or hematuria in either arm. More MVAC patients experienced grade 3/4 neutropenia (GC 56%, MVAC 61%, p=1.000), neutropenic or leukopenic fever (GC 0%, MVAC 10%, p=0.237), mucositis (GC 0%, MVAC 7%, p=0.495), and alopecia (GC 6%, MVAC 36%, p=0.004). GC represents a reasonable alternative for the palliative treatment of patients with locally advanced and metastatic transitional cell carcinoma. Sustained long-term survival was only found for patients with locally advanced cancer, lymphatic metastases, or solitary distant metastasis but not for visceral metastatic disease.

According to the report 2000 issued by the expert advisory committee on the health care system, improvement in performance requires, among other things, awareness of the need for more economic efficiency, better quality of medical care, and definition of targets. Disease prevention and early diagnosis are the main objectives of health policy and practice. Data mining becomes an important tool in epidemiological and clinical research. Urologists are called upon to engage in clinical studies to establish therapeutic standards and guidelines. Results of research must be put in to practice faster. Doctors ought to respond to changes in patients' attitudes.

Bladder cancer is a disease that occurs late in life (> 50% of the patients in Germany are 70 years or older). The general condition of the patients is frequently reduced, aggressive therapy of advanced tumours stages is therefore often contra-indicated. In this situation, palliative treatment is of extraordinary importance. Strangely enough, controlled prospective trials are lacking. They are, however, necessary in order to establish, or improve, standards of palliative treatment. Several smaller studies proved the potential of bladder irrigation and the embolisation of A. iliaca to stop bleeding from the tumourous bladder. If the tumour causes urinary retention, a permanent ureteral stent may in certain cases help to guarantee adequate flow. The assessment of palliative radiotherapy is not possible due to small numbers of (and highly selected) patients. It may have a potential in cases of hematuria, pain, and incontinence. New anti-tumour agents (e.g. Gemcitabine) may turn out to be a tolerable and effective palliative.

For the early detection of prostate cancer, a patient should undergo digital rectal examination (DRE) and PSA investigation. Follow-up of increased PSA levels detects nearly 80% of cancers. Positive predictive value of suspicious DRE and PSA is about 50%. Whereas in the first evaluation of this case-finding trial about 70% of the patients had organ-confined cancers, nearly all of the detected cancers in the follow-up investigation were organ confined. The increased number of organ-confined cancers detected in early periodical examinations can lead to a reduction of mortality and morbidity from prostate cancer.

In a time of scarce resources, the demand for a rational therapy is important in the present discussion to reform the health system. This article describes rational therapy and introduces practical approaches like drug therapy, evidence-based medicine, and clinical practice guidelines. The development of efficient cost-benefit relations may lead to more rationalization in the health sector. It is important to attain acceptance also among the patients that rationing in the health system is a necessary measure in diagnosis and therapy.