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Background: The role of immune checkpoint inhibitor (ICI) maintenance therapy in metastatic renal cell carcinoma (mRCC) is undefined., Objective: To determine whether switch maintenance therapy with nivolumab improves clinical outcomes in patients with mRCC with tyrosine kinase inhibitor (TKI) sensitivity., Design, Setting, and Participants: This open-label phase 2 trial randomized patients with a partial response or stable disease after 10-12-wk TKI induction therapy to either TKI or nivolumab maintenance. Key inclusion criteria were measurable disease, clear cell histology, Eastern Cooperative Oncology Group performance status (ECOG PS) 0-2, and adequate organ function., Intervention: Intravenous nivolumab 8 × 240 mg every 2 wk, followed by 480 mg every 4 wk or sunitinib 50 mg (4-2 regimen) or pazopanib 800 mg once daily orally., Outcome Measurements and Statistical Analyses: The primary endpoint was overall survival (OS). Secondary endpoints were the objective response rate (ORR; Response Evaluation Criteria in Solid Tumors v1.1), progression-free survival (PFS), safety (Common Terminology Criteria for Adverse Events v4.03), and patient-reported outcomes (Functional Assessment of Cancer Therapy Kidney Symptom Index). The Kaplan-Meier method, two-sided log-rank tests, and Cox regression models were used for statistical analysis., Results and Limitations: Maintenance therapy was nivolumab for 25 patients (51.0%) and TKI for 24 (48.9%). The median age was 65 yr (range 35-79). Nine patients (18.4%) were female, 31 (63.3%) had ECOG PS of 0, and 15 (30.6%) had favorable risk. OS data are immature (17 deaths, 34.7%). The ORR was 20.0% (n = 5) for nivolumab and 52.2% (n = 12) for TKI. PFS was worse with nivolumab (hazard ratio 2.57, 95% confidence interval 1.36-4.89; p = 0.003). Grade ≥3 adverse events occurred in 14 patients (56.0%) with nivolumab and 17 (70.8%) with TKI. A major limitation is early termination of our study., Conclusions: TKI treatment achieved superior ORR and PFS in comparison to nivolumab maintenance therapy. Our data do not indicate a role for nivolumab switch maintenance in mRCC., Patient Summary: Patients with metastatic kidney cancer who experienced a tumor response or disease stabilization after a short period of targeted treatment with a tyrosine kinase inhibitor did not benefit from a switch to the immunotherapy drug nivolumab. Patients who continued their original treatment achieved better responses and a longer time without disease progression. This trial is registered on EudraCT as 2016-002170-13 and on ClinicalTrials.gov as NCT02959554., (Copyright © 2023 European Association of Urology. Published by Elsevier B.V. All rights reserved.)

Drug-based hormonal ablation is an essential component of therapy in hormone-sensitive advanced prostate cancer and as a backbone in castration resistance. LHRH agonists are among the most widely used medicinal products. Since these are usually given for life, therapy management is very important. Common side-effects typical of the substance class, such as weight gain, cardiovascular problems, hot flushes, erectile dysfunction or osteoporosis, can significantly reduce patients' quality of life and increase morbidity and mortality. This endangers adherence and, hence, treatment success. This paper provides an overview of how to deal with side-effects during LHRH therapy based on current data and practical experience., Competing Interests: Eva Hellmis Honoraria: Bayer, Merck, AstraZeneca, Janssen Oncology, Pfizer, Eisai, Apogepha, MSD, Consulting or Beratertätigkeit: MSD Oncology, AstraZeneca, Bayer, Bristol Myers Squibb, Merck, Pfizer, Janssen Oncology, Astellas Pharma, MSD, Travel Accommodations, Expensen: AstraZeneca, MSD Oncology, Pfizer, Sanofi, Merck, Apogepha, Eisai, Pfizer, Bayer Tobias N. Mudra Ehemaliger Arbeitgeber: APOGEPHA Arzneimittel GmbH Axel Merseburger Honoraria: AstraZeneca, Astellas, Bayer, Bristol-Myers Squibb, Eisai, EUSAPharma, Ferring Ipsen, MedUpdate, MSD, Merck Serono, Janssen, Pfizer, Takeda, Novartis, Recordati und Roche Beratertätigkeit: AstraZeneca, Astellas, Bayer, Bristol-Myers Squibb, Eisai, EUSAPharma, Ferring, Ipsen, MedUpdate, MSD, Merck Serono, Janssen, Pfizer, Takeda, Novartis, Recordati und Roche Forschungsförderung: AstraZeneca, Astellas, Bayer, Bristol-Myers Squibb, Eisai, EUSAPharma, Ipsen, MedUpdate, MSD, Merck Serono, Janssen, Pfizer, Takeda, Novartis, Recordati und Roche, (Thieme. All rights reserved.)

Competing Interests: Disclosure The authors report no conflicts of interest in this work.

Non-metastatic castration-resistant prostate carcinoma (M0CRPC) is associated with an increased risk of progression and mortality, especially if the prostate-specific antigen doubling time is short (PSADT ≤ 10 months). The risk of progression and mortality increases even further if the disease progresses to the metastatic stage (mCRPC). The androgen receptor inhibitors apalutamide, darolutamide and enzalutamide, each in combination with androgen deprivation therapy (ADT), are available for the treatment of patients with high-risk M0CRPC.Data from the pivotal SPARTAN study showed that apalutamide + ADT delayed metastasis-free survival (MFS) and thus also the development of mCRPC in these patients. Prior to the approval of apalutamide in the European Union, the active substance was available in Germany as part of an international compassionate use program. A total of 109 patients from 50 centres participated in Germany: 45 patients were treated for more than 3 months and 13 patients for more than 6 months. The compassionate use program continues in some countries; 556 patients have been enrolled worldwide.In our experience, this real-world population showed a good PSA response, which was also shown for this exploratory endpoint in the SPARTAN study. We were also unable to identify any significant differences from the pivotal trial with regards to the tolerability profile.Apalutamide in combination with ADT was also effective in this real-world population and led to a rapid decrease in PSA. The tolerability profile did not differ from that in the SPARTAN trial., Competing Interests: Dr. Eva Hellmis: Beratertätigkeiten für Janssen-Cilag, Takeda, Eisai, Apogepha, Jenapharm, Bayer-Vital, Ipsen, MSD, BMS, Sanofi-Genzyme, Pfizer, Astra Zeneca, Astellas; Referentenhonorare von Janssen-Cilag, Takeda, Eisai, Apogepha, Jenapharm, Bayer-Vital, Ipsen, MSD, BMS, Sanofi-Genzyme, Pfizer, Astra Zeneca, Astellas; Hexal; Studienhonorare im Rahmen von durchgeführten klinischen Studien an das Urologicum Duisburg; Prof. Christian Schwentner: Forschungsunterstützung von Astellas, Johnson & Johnson, Numares, Sanofi, Roche, Novartis; Beratertätigkeit für Intuitive Surgical, Astellas, Janssen, Sanofi, Roche, BMS, Johnson & Johnson, EUSA, MSD; Aktien von Abbot; Dr. Philipp Mandel: Beratertätigkeit für Sanofi, Bayer, Janssen; Vortragshonorare von Bayer, Sanofi, Astellas, Janssen, Ipsen; Dr. Severine Banek: Vortragshonorare von Pfizer; Dr. Jochen Gleißner: Forschungsunterstützung von Janssen; Prof. Martin Bögemann: Forschungsunterstützung von Janssen, Astellas, Bayer, Amgen, Novartis, Sanofi, Eusapharm, Pfizer, BMS, MSD, Merck, Eisai, Nektar Therapeutics, AstraZeneca, BioClin Therapeutics, Incyte, Exelexis; Beratertätigkeit für Janssen, Astellas, Bayer, Amgen, Novartis, Sanofi, Pfizer, BMS, MSD, Merck, Eisai, AstraZeneca, Exelexis, ABX; Vortragshonorare von Janssen, Astellas, Bayer, Amgen, Novartis, Sanofi, Eusapharm, Pfizer, BMS, MSD, Eisai, AstraZeneca, (Thieme. All rights reserved.)

During phase III study ERA-223, patients under combination therapy with radium-223 and abiraterone showed an increased risk of bone fractures and a possible higher risk of death. This observation led to a change in the German therapeutic guidelines in 2018. Radium-223 is now only allowed as a third-line monotherapy (besides ADT) in patients with metastatic castration resistant prostate cancer (mCRPC) with symptomatic bone lesions without known visceral metastases or for patients with mCRPC, for whom no other available systematic therapy is suitable. Since almost no data on practice-related care research on the use of radium-223 exist, we consulted members of d-uo (German Uro-Oncologists) over their therapy algorithms. This study analysed data of patients treated with radium-223 between 2014 and 2019. It could be shown that 50% of mCRPC-patients had received radium-223 in the past as third-line therapy. Half of these were treated in combination with new androgen receptor targeted therapies (ARTA) and no increase in bone fractures was observed. This was most likely due to the additional use of bone protecting agents. Despite the late cancer stage, treatment response was seen in almost half of the patients., Competing Interests: Die Autoren R. Schönfelder, J. Klier, M. Johannsen und F. König erhielten in der Vergangenheit von der Firma BAYER Unterstützungen für Kongressreisen sowie Honorare für die Teilnahme an Advisory Boards und für das Halten von Vorträgen., (Thieme. All rights reserved.)

Competing Interests: Disclosure The authors report no conflicts of interest in this work.

Background and Objective: The aim of this study was to evaluate gender aspects and trends in urological clinics, research and private practice. The focus was on the objectification of gender-specific changes in the field of urology at the current time and in the future., Material and Methods: A digital survey among urological physicians in Germany was conducted with the SurveyMonkey© portal, which was sent to all registered members via the email distribution lists of the German Society of Urology (DGU) and the Professional Association of German Urologists (BvDU). Baseline data were collected in the outpatient and inpatient sectors, as were gender-specific data related to job distribution, goals, satisfaction, and reasons for career decisions., Results: The analysis of 398 responses revealed that urological colleagues in private practice were less likely to be female (23.6%) and significantly older (mean age 53 years) than in the inpatient sector (female proportion 47.2%, mean age 43 years). More men (49.4%) than women (29.9%) were in private practice and this was indicated as a career aspiration by more men than women (28.1% vs. 22.8%). The reasons for setting up a practice were more often family-related for women than for men (main reasons good opportunity or career aspiration). Women were more likely to work part-time (27.0% vs. 11.5%) and more likely to aspire to a career as a senior physician (29.1% of women, 9.4% of men). Correspondingly, the desire for a postdoctoral position or professorship was more common among women than among men (20.5% vs. 15%). Significantly more female urologists perceived inequality in career advancement opportunities (59.7% vs. 17.5%, p < 0.001) and 73.3% (vs. 18.5% of men, p < 0.001) perceived their gender as a cause of disadvantage. This resulted in significantly lower satisfaction of women with their professional status (p = 0.008) as well as a lower feeling of being valued (p < 0.001)., Conclusion: In order to prepare our specialty field for the future, it is essential to give even greater consideration to gender aspects. The path taken to offer the next generation of urologists a modern specialty in which all physicians, regardless of their gender, enjoy working, are valued and where equal opportunities prevail, should definitely be pursued and intensified in order to position urology well for the future., (© 2022. The Author(s).)

Background: Although the benefit of androgen deprivation therapy (ADT) continuation in metastatic castration-resistant prostate cancer (mCRPC) remains controversial, clinical evidence is lacking. Recent results indicated that treatment with abiraterone acetate (AA) plus prednisone (P) further suppresses serum testosterone levels over ADT alone, suggesting that continuation of ADT in the treatment of mCRPC may not be necessary., Methods: In this exploratory phase 2 study, mCRPC patients were randomized with a 1:1 ratio to receive either continued ADT plus AA + P (Arm A) or AA + P alone (Arm B). The primary endpoint was the rate of radiographic progression-free survival (rPFS) at month 12. Secondary endpoints included PSA-response rate, objective response, time to PSA progression and safety., Results: A total of 68 patients were equally randomized between the two study arms. Median testosterone-levels remained below castrate-levels throughout treatment in all patients. According to the intention-to-treat analysis the rPFS rate was 0.84 in Arm A and 0.89 in Arm B. Moderate and severe treatment-emergent adverse events were reported for 72% of the patients in Arm A and for 85% of the patients in Arm B., Conclusions: AA + P treatment without ADT may be effective in mCRPC patients and ADT may not be necessary in patients receiving AA + P., (© 2022. The Author(s).)

Background: Prior durvalumab (anti-PD-L1 agent) studies in platinum-refractory metastatic urothelial carcinoma evaluated a dose of 10 mg/kg administered every two weeks. The nonrandomised phase 3b STRONG study (NCT03084471) evaluated the safety and efficacy of fixed-dose durvalumab at a more convenient dosing schedule in a previously treated patient population, more similar to a real-world clinical setting., Patients and Methods: 867 patients with urothelial or nonurothelial urinary tract carcinoma (UTC) who progressed on or after platinum or nonplatinum chemotherapy were treated with durvalumab 1500 mg every four weeks; 87% had an Eastern Cooperative Oncology Group performance status (ECOG PS) of 0-1, and 13% had an ECOG PS of 2. The primary end-point was the incidence of adverse events of special interest (AESIs), including immune-mediated AEs (imAEs). Secondary and exploratory end-points included overall survival (OS), objective response rate (ORR) and disease control rate (at six and 12 months) (DCR)., Results: AESIs of any grade were reported in 51% of patients (8% grade ≥ 3). The incidence of imAEs was 11% (2% grade ≥ 3). The median OS was 7.0 months (95% confidence interval [CI]: 6.4-8.2) and ORR was 18% (95% CI: 14.8-20.6), with complete responses in 5% of patients and a DCR at six months of 19% (95% CI: 16.1-22.1)., Conclusion: Fixed-dose durvalumab monotherapy every four weeks has an acceptable safety profile and yields durable clinical activity in previously chemotherapy-treated patients with UTC. Safety and efficacy are consistent with previous durvalumab studies and other anti-PD-1/PD-L1 agents in this setting. CLINICALTRIALS., Gov Identifier: NCT03084471https://clinicaltrials.gov/ct2/show/NCT03084471., Competing Interests: Conflict of interest statement The following authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper: Sang Joon Shin and Guilhem Roubaud. The following authors declare the following financial interests/personal relationships that may be considered as potential competing interests: Guru P. Sonpavde: Has received grants or contracts (institution) from AstraZeneca, Janssen, and Sanofi; Consulting fees from Astellas Pharma, AstraZeneca, Bicycle Therapeutics, Bristol-Myers Squibb, Eisai, EMD Serono, Exelixis, Genentech, Janssen, Merck, Pfizer and Seattle Genetics; Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Medscape, Onclive, Physicans' Education Resource and Research to Practice; Support for attending meetings and/or travel from Bristol-Myers Squibb; Other financial or non-financial interests from Astellas Pharma, AstraZeneca, Bavarian Nordic, Bristol-Myers Squibb, Debiopharm Group, Elsevier and QED Therapeutics. Cora N. Sternberg: Has received consulting fees from Astellas Pharma, AstraZeneca, Bayer, Genzyme, Immunomedics, Incyte, Medscape, Merck, Merck Sharp & Dohme, Pfizer, Roche and UroToday. Yohann Loriot: Has received grants or contracts (institution) from AstraZeneca, Boehringer Ingelheim, Clovis Oncology, CureVac, Exelixis, Incyte, Janssen Oncology, Medivation, Merck Sharp & Dohme Oncology, Nektar, Oncogenex, Pfizer and Sanofi; Consulting fees from Astellas Pharma, AstraZeneca; Clovis Oncology, Bristol-Myers Squibb, Janssen, Merck Sharp & Dohme Oncology, Roche and Seattle Genetics and institution consulting fees from Janssen and Merck Sharp & Dohme Oncology; Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Pfizer and Sanofi; Support for attending meetings and/or travel Astellas Pharma, AstraZeneca; Janssen Oncology, Merck Sharp & Dohme Oncology, Roche and Seattle Genetics. Jae Lyun Lee: Has received grants or contracts (institution) from AstraZeneca/MedImmune, Bayer Schering Pharma, Bristol-Myers Squibb, Janssen, Merck Sharp & Dohme, Novartis, Pfizer and Roche/Genentech and Seattle Genetics; Consulting fees from Alteogen, Bristol-Myers Squibb, GI Innovation, Merck Sharp & Dohme, Pfizer and Sanofi/Aventis; Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Astellas Pharma, AstraZeneca, Bristol-Myers Squibb, Merck Sharp & Dohme and Pfizer; Stock or stock options from Immunomedics and Myovant Sciences. Aurelien Marabelle: Has received grants or contracts (institution) from Boehringer Ingelheim, Bristol-Myers Squibb, MERUS, MSD and Transgene; Consulting fees from AstraZeneca Bayer, Boehringer Ingelheim, CERENIS THERAPEUTICS, Eisai, Gritstone Oncology, HiFiBiO Therapeutics, ImCheck therapeutics, Innate Pharma, Lytix Biopharma, Merck Serono, Molecular Partners, Merck Sharp & Dohme, OSE Immunotherapeutics, Pierre Fabre, Redx Pharma, Roche, Sanofi, SERVIER, Sotio, Symphogen; Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from AstraZeneca, Bristol-Myers Squibb, Merck Sharp & Dohme; Support for attending meetings and/or travel from AstraZeneca and Merck Sharp & Dohme; Patents planned, issued or pending from Stanford University (Monoclonal antibodies against CD81); Stock or stock options from HiFiBiO Therapeutics and PEGASCY and PEGASCY (insitition); Other financial or non-financial interests from PEGASCY; Honoraria received from Elsevier as an editor for the European Journal of Cancer. AudeFléchon: Has received payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events and/or support for attending meetings and/or travel rom Astellas Pharma, AstraZeneca, Bayer, Bristol-Myers Squibb, Ipsen, Janssen-Cilag, Merck Sharp & Dohme Oncology, Pfizer, Roche/Genentech and Sanofi/Aventis. Damien Pouessel: Has received has received grants or contracts (institution) from AstraZeneca, Bristol-Myers Squibb, Incyte, Janssen Oncology, Merck Sharp & Dohme, Roche and Seattle Genetics; Consulting fees from Astellas Pharma, AstraZeneca, Janssen Oncology, Pfizer and Sanofi; Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Astellas Pharma, AstraZeneca, Bristol-Myers Squibb, Ipsen, Janssen Oncology and Merck; Support for attending meetings and/or travel from AstraZeneca, Janssen Oncology and Pfizer. Vittorina Zagonel: Has received has received grants or contracts (institution) from Astellas Pharma, AstraZeneca, Bayer, Bristol-Myers Squibb, Ipsen, Lilly and Roche; Consulting fees from Bristol-Myers Squibb and Merck; Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Astellas Pharma, AstraZeneca, Bayer, Bristol-Myers Squibb, Lilly, Roche and Servier; Support for attending meetings and/or travel from Bayer, Roche and Servier. Fabio Calabro: Has received consulting fees from Merck Sharp & Dohme Oncology and Pfizer. Giuseppe L. Banna: Has received consulting fees from AstraZeneca, Boehringer Ingelheim, Janssen-Cilag and Roche; Support for attending meetings and/or travel from AstraZeneca/MedImmune, Bristol-Myers Squibb, Ipsen and Pierre Fabre; Patents planned, issued or pending with ST Microelectronics “Deep Learning Motion Algorithm for Lung Cancer Early Detection in Embedded Systems” and “Image processing method, corresponding system and computer program product”. Francisco E. Vera-Badillo: Has received grants or contracts (institution) from AstraZeneca/MedImmune. Thomas Powles: Has received has received grants or contracts, consulting fees and/or payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Astellas Pharma, AstraZeneca, Bristol-Myers Squibb, Eisai, Exelixis, Incyte, Ipsen, Johnson & Johnson, Merck, Merck Serono, Merck Sharp & Dohme, Novartis, Pfizer, Roche and Seattle Genetics; Support for attending meetings and/or travel from AstraZeneca, Ipsen, Merck Sharp & Dohme, Pfizer and Roche. Eva Hellmis: Has received support for attending meetings and/or travel from Janssen-Cilag. Paulo A. P. Miranda is a current employee of AstraZeneca with AstraZeneca stock or stock options. Ugochi Emeribe and Sun Min Oh are current employees of AstraZeneca. Ana Rita Lima is currently employed as a Third Party Service Provider to AstraZeneca. Sebastien J. Hotte: Has received grants or contracts (institution) from Astellas Pharma, AstraZeneca, Ayala Pharmaceuticals, Bristol-Myers Squibb, Clovis Oncology, Janssen Oncology, Merck, Pfizer, Roche/Genentech, Seattle Genetics and SignalChem; Consulting fees from Astellas Pharma, AstraZeneca, Bayer, Bristol-Myers Squibb, Eisai, Ipsen, Janssen, Merck, Pfizer and Roche Canada; Payment or honoraria for lectures, presentations, speakers bureaus, manuscript writing or educational events from Astellas Scientific and Medical Affairs Inc, Bayer, Janssen Oncology and Merck; Support for attending meetings and/or travel from Eisai., (Copyright © 2021 The Author(s). Published by Elsevier Ltd.. All rights reserved.)

In patients with nonmetastatic castration-resistant prostate cancer (nmCRPC or M0CRPC) at high risk of progression (defined as prostate-specific antigen [PSA] doubling time ≤ 10 months), new androgen receptor inhibitors (ARI) in combination with continued androgen deprivation therapy (ADT) are considered the new standard of care. Apalutamide, enzalutamide, and darolutamide have been approved on the basis of improved metastasis-free survival (MFS) in the respective large pivotal studies SPARTAN, PROSPER and ARAMIS and now, with a longer follow-up period, were able to show also a statistically significant and clinically relevant overall survival advantage compared to placebo plus ADT. The data available to date indicate that all three ARIs are comparably effective, accompanied by good tolerability. Moreover, the generally good quality of life of this patient population, who usually has no tumor-related symptoms, was maintained. Comparative head-to-head trials of the three approved substances are not available yet.

Objective: To compare, in a retrospective observational cohort study, the efficacy, tolerability and safety of propiverine and oxybutynin in children with urge incontinence (UI) due to overactive bladder., Patients and Methods: Medical records were scrutinized for children with UI. As a primary efficacy outcome variable the achievement of continence after treatment with variable doses of propiverine or oxybutynin was assessed. Weekly UI episodes and daily voiding frequency were evaluated as secondary efficacy outcomes. Tolerability was evaluated by the rate of adverse events, adverse drug reactions caused by antimuscarinics and premature treatment termination., Results: At 16 study centres, 621 children aged 5-14 years with UI due to overactive bladder were enrolled. After anticholinergic treatment (437 propiverine, 184 oxybutynin) continence was achieved in 61.6% and 58.7% of the patients after 186 and 259 days, respectively. There were clinically relevant improvements in voiding frequency across treatment groups. Daily doses of propiverine were markedly below the recommendations (0.54 vs 0.8 mg/kg body weight), daily doses of oxybutynin were according to the recommendations (0.31 vs 0.2-0.4 mg/kg body weight) at treatment initiation. There was a significantly more favourable tolerability to propiverine than oxybutynin for the overall rate of adverse events (3.9% vs 16.3%, odds ratio 4.813), adverse drug reactions caused by propiverine or oxybutynin (2.8% vs 9.2%) and premature treatment termination due to adverse drug reactions (1.6% vs 4.4%)., Conclusion: Propiverine and oxybutynin are effective in children with UI due to overactive bladder. Sufficient treatment periods of at least 2, preferably 3-4, months are the crucial factors for a successful treatment. The tolerability profile of propiverine is better than for oxybutynin.

Sexual function can be altered in patients with different types of epileptic disorder, especially those with temporal lobe epilepsy. The awareness of sexual function disturbances, giving an enormous impact on someone's quality of life, should lead to therapeutic measures. The incidence, evaluation and therapeutic options are demonstrated and seen through the urologist's eyes.

Lycopene is a promising nutritional component for chemoprevention of prostate cancer (PCa). A possibly beneficial role of lycopene in patients diagnosed with benign prostate hyperplasia (BPH), who are at increased risk of developing PCa, has been suggested, although clinical data are lacking. Therefore, this pilot study aimed to investigate the effects of lycopene supplementation in elderly men diagnosed with BPH. A total of 40 patients with histologically proven BPH free of PCa were randomized to receive either lycopene at a dose of 15 mg/d or placebo for 6 mo. The effects of the intervention on carotenoid status, clinical diagnostic markers of prostate proliferation, and symptoms of the disease were assessed. The primary endpoint of the study was the inhibition or reduction of increased serum prostate-specific antigen (PSA) levels. The 6-mo lycopene supplementation decreased PSA levels in men (P < 0.05), whereas there was no change in the placebo group. The plasma lycopene concentration increased in the group taking lycopene (P < 0.0001) but other plasma carotenoids were not affected. Whereas progression of prostate enlargement occurred in the placebo group as assessed by trans-rectal ultrasonography (P < 0.05) and digital rectal examination (P < 0.01), the prostate did not enlarge in the lycopene group. Symptoms of the disease, as assessed via the International Prostate Symptom Score questionnaire, were improved in both groups with a significantly greater effect in men taking lycopene supplements. In conclusion, lycopene inhibited progression of BPH.