Previously presented Prostate Imaging Reporting and Data System version 2 (PI-RADS v2) system was developed on the basis of consensus that was achieved by the results of published studies containing expert and analytical conclusions. Numerous studies on PI-RADS v2, not only confirmed the importance of a unified system in the diagnosis of prostate cancer, but also revealed a number of limitations. In order to eliminate flaws of PI-RADS v2, a number of potential solutions were proposed. The PI-RADS Steering Committee recommended changes in PI-RADS v2, with maintaining the structure of sequence scoring and using these scores to obtain the final category. The updated version was published as PI-RADS v2.1 at the beginning of 2019. It is expected that the use of PI-RADS v2.1 will optimize and simplify the evaluation magnetic resonance imaging of prostate and reduce the number of interpretation errors. At the same time, it is necessary to continue further studies on the assessment of the clinical significance of this system when choosing a treatment strategy and monitoring patients with a high potentialfor the development

Background. Renal cell carcinoma is a heterogeneous group of tumors characterized by high vascularization and immunogenicity. Immunotherapy has made a breakthrough in the treatment of this pathology, however, the lack of development of criteria for its use does not allow to achieve even greater success. It is known that the tumor stroma plays an important role in the success of immunotherapy. Among the various histological types of kidney tumors, the stroma of the clear cell renal cell carcinoma has been studied in sufficient detail. However, the remaining histological types are practically not studied.

Objective: description of the immunosuppressive phenotype of the stroma of kidney tumors of various histological types.

Materials and methods. The study included tumor samples obtainedfrom 44patients with renal cell carcinoma of various histological types (16 samples of chromophobe cancer, 15 samples of clear cell and 13 samples of papillary renal cell carcinoma). The method of immunohis-tochemistry evaluated the expression of tumor stromal markers, namely CD68, CD206, PU.1, CD3, IDO1 and PD-L1 in the studied samples.

Results. Analysis of the total number of macrophages associated with the tumor showed that the smallest number is observed in samples of chromophobe renal cancer, while in the samples of clear cell cancer their number is greatest. A similar situation is observed for T-cells: the largest number of CD3+ cells is observed in clear cell tumors. In chromophobe and papillary tumors, their number is reduced. Papillary tumors are also characterized by an almost complete absence of expression of PD-L1 and IDO1 compared to other histological types of kidney tumors. We also showed that for PU.1 there is a strong positive correlation between its quantity and localization, as in CD68. Thus, PU.1 can be used as a general marker for describing stromal macrophages in kidney tumors.

Conclusion. The study showed that kidney tumors of various histological types strongly and significantly differ in the composition of their microenvironment. These data, of course, must be considered when choosing immune therapy in the treatment of this pathology.

Background. Minimally invasive partial nephrectomy is the gold standard in the treatment of stage I malignant tumors. To date, there are a large number of techniques for performing partial nephrectomy. The desire to develop a technique that included all the positive characteristics and had no restrictions on use led to the creation of a normotonic zero ischaemia partial nephrectomy.

Materials and methods. A retrospective analysis of 45 patients was performed. 1st group included 24 (53.3 %) patients after laparoscopic normotonic zero ischaemia partial nephrectomy. 2ndgroup included 21 (46.7 %) patients who underwent laparoscopic hypotonic zero ischaemia partial nephrectomy. All patients evaluated such surgical parameters as the surgery time, the blood loss, and the duration of hospitalization. To assess pre-operative renal function, the CKD-EPI equation was used to calculate estimate glomerular filtration rate.

Results. All patients were demographically comparable. Patients were also evenly distributed in terms of resection complexity according to the RENAL nephrometric scale. Acute kidney injury rate was significantly higher in the hypotension group: relative risk 5.4 (95 % confidence interval 1.59—20.55), odds ratio 11.3 (95 % confidence interval2.04—59.2);p = 0.007. In 1stgroup, the average operation time was 130min (Q1-Q3 110—140), and in 2ndgroup, 150min (Q1—Q3 115—227.5);p = 0.0159. The average volume of blood loss during laparoscopic zero ischaemia partial nephrectomy was significantly less than during hypotonic partial nephrectomy: 125 ml (Q1—Q3 50—200) and 450 ml (Q1— Q3200— 750) respectively, p <0.0001.

Coclusion. In our study, laparoscopic normotonic zero ischaemia partial nephrectomy proved to be a possible alternative to existing resection techniques today. But to use this technique in clinical practice, further study and validation is required.

Background. Laparoscopic partial nephrectomy (LPN) in the treatment of small kidney tumors is widespread, but the operation is associated with warm ischemia, which adversely affects the functional state of the kidney. Research is underway on methods of partial nephrectomy with a reduction of thermal ischemia or zero ischemia. The laser energy is one of the directions in the search for options for LPN. The aim of our work is to improve the LPN using a thulium laser.

Materials and methods. From 2017 to 2019 a LPN was performed for 16 patients with small tumors, using the thulium laser with a wavelength of 1.94 ^m. There were men 7 (43.8 %), women — 9 (56.2 %), average age was 51 (39—68) years, average kidney tumor size was 24.9 (15—40) mm. The evaluation of laser resectability on the RENAL scale was carried out using 3D modeling. We used the laparoscopic laser aspirator-irrigator to reduce smoke generation during the procedures.

Results. The average time of LPN using a fiber thulium laser was 97.5 (70—131) min. The time for kidney resection was 25.6 (10—40) min. 14 (87.5 %) procedures performed completely without warm ischemia. The average blood loss during surgery was 111.3 (50—250) ml. The duration of postoperative treatment was 7.1 (5—9) days. A positive surgical margin was not observed. Histological examination revealed renal cell carcinoma in 14 (87.5 %) patients, G2 — 10 (71.4 %), G2 — 4 (28.6 %). When examining glomerular filtratoin rare in the operated patients after procedures, no changes were observed.

Conclusion. The use of the thulium laser for LPN allows perform the procedure without warm ischemia in selected patients with a predominantly extrarenal tumor location. The use of a laparoscopic instrument the laser aspirator-irrigator with a drip water supply and simultaneous aspiration reduced smoke generation during laser thulium resection, the operation performed under conditions of improved visualization, which prevents the danger of a positive surgical edge. Further monitoring of the results of applying the method of thulium laser LPN is required.

Background. Currently there exists a wide range of advanced renal cell carcinoma (RCC) treatment schemes, among them cabozantinib, registered in Russia in 2019, was approved as a second-line therapy in both foreign and domestic guidelines.

Objective: to conduct a comparative clinical and economic analysis of cabozantinib and alternative drugs in adult patients with advanced RCC after previous systemic therapy.

Materials and methods. A literature review was conducted on clinical efficacy and safety of various second-line therapy drugs for advanced RCC in the available databases. The foreign partitioned survival model, reflecting the development of widespread RCC when using 4 different second-line therapy drugs (cabosantinib, nivolumab, axitinib and everolimus), was adapted considering 3 consecutive mutually exclusive conditions (before progression, after progression, death). Pharmacoeconomic analysis included “cost-effectiveness” and “cost-utility” analysis. We estimated direct medical costs for second- and third-line therapy and maintenance therapy (outpatient monitoring and palliative care). To estimate drug costs we used prices from the State Register of maximum selling prices, for cabozanthinib — price presented by the manufacturer. Costs of maintenance therapy were estimated based on the normal standardfor financial costs in accordance with the Program of state guarantees for 2020.

Results. Efficacy analysis based on the partitioned survival model showed the highest rates of life-years gained (3.18 life-years-gained (LYG)) and quality adjusted life-years (1.87quality adjusted life-years (QALY)) for cabozanthinib compared with nivolumab (2.53 LYG and 1.6 QALY), axitinib and everolimus (2.21 LYG and 1.31 QALY). Total costs for advanced RCC patients when treated with cabozanthinib were 4.3 million rubles, which is 5 % less than when using nivolumab (4.5 million rubles). Total costs for axitinib were 2.1 million rubles, while its effectiveness was lower compared with the cabozanthinib one. Costs of 1 life-year saved for cabozantinib were 1.4 million rubles, which is 25 % less compared to those for nivolumab. Costs of 1 quality-life year saved when using cabozantinib amounted 2.3 million rubles, which is 19 % less than those for nivolumab.

Conclusion. The study results showed that using cabozantinib to treat advanced RCC after previous systemic treatment is both clinically and cost-effective for adult patients with advanced RCC in the Russian Federation.

Background. Prostate cancer (PCa) is one of the most common malignancy in men. A traditional marker in the laboratory diagnosis ofPCa is the prostatic specific antigen (PSA). However, the low specificity of this marker leads to a large number of unnecessary biopsies. The emergence of various modifications of PSA and tumor-specific genetic markers such as PCA3 and TMPRSS2ERG, have improved the diagnosis of PCa.

Objective. Investigation of the diagnostic significance of molecular genetic markers, PCA3 and TMPRSS2:ERG, and their comparison with markers based on PSA isoforms: free/total PSA ratio (%fPSA) and prostate health index (PHI).

Materials and methods. The study included 58 men with suspected PCa. All patients were defined PCA3 score and the presence of TMPRSS2:ERG fusion transcript in the urine sediment. Also, PHI and %fPSA were determined in 48 and 51 men, respectively.

Results. The area under the ROC-curve regardless of the value of PSA was higher for PCA3 score (0.773, p <0.001), than for %fPSA and PHI: 0.625 (p = 0.131) and 0.735 (p = 0.006), respectively. At clinical sensitivity >95 % PCA3 score had the highest specificity, positive and negative predictive values in men, regardless of the level of PSA: 65.22, 80.95, and 93.75 %, respectively. In men with PSA level of 2—10 ng/ml the area under the ROC-curve for PCA3, %fPSA and PHI was 0.776 (p = 0.001), 0.629 (p = 0.144) and 0.729 (p = 0.009), respectively. At high sensitivity (>95 %) characteristics of the diagnostic test PCA3 in men with a PSA level of 2—10 ng/ml also also exceeded those for PHIand %>fPSA. The negative predictive valuefor PCA3score in this group ofmen was 100 %. The sensitivity ofdetection ofthe TMPRSS2:ERG fusion transcript in urine was 37.14 %, specificity 86.96 %, and the positive predictive value was 81.25 %.

Conclusion. The use ofthe PCA3 score in combination with the detection of TMPRSS2:ERG fusion will improve the assessment of PCa risk in men with PSA levels between 2 and 10ng/ml (the “grey zone”).

Background. Selecting patients for radical prostatectomy (RP) using nerve-sparing technique (NST) is crucial to optimize oncological and functional results. Correlation of multiparametric magnetic resonance imaging (mpMRI) data with RP results remains insufficiently studied, at the same time existing prognostic tools and nomograms show moderate effectiveness during third-party validation and have some drawbacks. Objective: to study pathomorphological results and evaluate the recurrence-free survival of patients after RP, depending on mpMRI data; develop a patient selection algorithm for NST.

Materials and methods. The study included 95 patients with clinically localized prostate cancer (PCa), who underwent RP within 2012—2017. All mpMRI series were retrospectively reviewed and evaluated using the Prostate Imaging Reporting and Data System (PI-RADS) version 2 (v2) by one radiologist diagnostician who neither had access to database and clinical information about patients nor participated in data collection and statistical analysis. Patients were divided into 2 groups: low probability of PCa and suspected PCa (PI-RADS 2—3; n = 43); high and very high probability of PCa (PI-RADS 4—5; n = 52). We assessed the presence of positive surgical margins, as well as extracapsular extension and relapse-free survival. We also developed an algorithm to select patients for nerve-sparing PCa based on the PI-RADS category according to mpMRI data.

Results. PI-RADS 2—3 group showed less positive surgical margins as compared to PI-RADS 4—5group (2.3 % versus 21.2 %; p = 0.025), as well as no cases of tumor extracapsular extension versus 36.5 % in PI-RADS 4—5group (p <0.001). Patients with Gleason score 6 after demonstrated the same trends: extracapsular extension on the tumor side was observed in 0 and 33.3 % of cases (p <0.001), positive surgical margins — in 2.4 and 15.2 % of cases (p = 0.046), respectively. An increase of the Gleason score after RP was observed in 12.2 % of patients of PI-RADS 2—3 group and in 30.3 % of PI-RADS 4—5 group (p = 0.04). Recurrence-free survival after 60 months was 93.0 and 71.1 %, respectively (p = 0.015).

Conclusion. Risk categories for PCa according to mpMRI data are associated with pathomorphological results and recurrence-free survival after RP. Using PI-RADS v2 categories in the patient selection algorithm for NST optimizes the assessment of oncological safety and allows selecting a group of patients for a thorough individual analysis of the benefit/risk profile.

Background. Prostate cancer is one of the most common malignant diseases among men. Until recently, the most common treatment of nonmetastatic castration-resistant prostate cancer (nmCRPC) in Russia was to continue previously started hormonal therapy. Enzalutamide is a second-generation anti-androgen indicated for treatment of CRPC, regardless of a patient’s metastatic status, which significantly increases metastasis-free survival in nmCRPC compared with androgen deprivation therapy (ADT).

Objective: to evaluate the incremental cost-effectiveness ratio (ICER) of enzalutamide use in patients with nmCRPC and the ICER of abiraterone as the first-line therapy for mCRPC from the Russian healthcare system perspective.

Materials and methods. Standard ADT regimens for nmCRPC were used as a comparator as it was the only approved treatment for nmCRPC in Russia. We proposed a Markov model of CRPC progression on enzalutamide plus ADT (hereinafter enzalutamide) or ADT based on PROSPER trial data. Model was used to calculate progression-free life years and costs of nmCRPC and post-progression CRPC treatment. Simulation period was 5 years with one cycle of 1 month. In the “cost–effectiveness” analysis, we calculated enzalutamide ICER compared to ADT. In addition, we calculated ICER for abiraterone plus ADT and prednisolone (hereinafter abiraterone) vs ADT + prednisolone in the first-line therapy of metastatic CRPC (mCRPC) as a benchmark. In both cases, time to disease progression over a 5-year period was used as an efficacy criteria.

Results. According to the Markov model, progression-free life-years gained for enzalutamide were 3.12 years compared to 1.79 for ADT within a 5-year period. The average enzalutamide therapy costs were 7,989,475.8 rubles/1 patient for 5 years, which were 5,716,983.5 rubles higher than when using ADT (2,272,492.3 rubles). ICER for enzalutamide (vs ADT) was 4,307,136.3 rubles per one progression-free life-year gained. ICER for abiraterone in the first line of mCRPC treatment (vs ADT + prednisolone) was 6,191,617.4 rubles per one progression-free life-year gained.

Conclusion. In the Russian healthcare system, ICER for enzalutamide in nmCRPC was 4,307,136.3 rubles and the ICER for abiraterone in mCRPC was 6,191,617.4 rubles. 

The aim of the review was to systematize the evidence available in the world literature on the influence of the role of microbiota and urinary microbiome on the development of bladder cancer. Given the constant development of medical technologies, patient examination algorithms, an obligate range of diagnostic tools, and the appropriateness of using the latest laboratory techniques are being reviewed.

Background. Atezolizumab can induce sustained responses in metastatic urothelial carcinoma. We report the results of IMvigor130, a phase III trial that compared atezolizumab with or without platinum-based chemotherapy versus placebo plus platinum-based chemotherapy in first-line metastatic urothelial carcinoma.

Materials and methods. In this multicentre, phase III, randomised trial, untreated patients aged 18 years or older with locally advanced or metastatic urothelial carcinoma, from 221 sites in 35 countries, were randomly assigned to receive atezolizumab plus platinum-based chemotherapy (group A), atezolizumab monotherapy (group B), or placebo plus platinum-based chemotherapy (group C). Patients received 21-day cycles of gemcitabine (1000 mg/ml body surface area, administered intravenously on days 1 and 8 of each cycle), plus either carbo-platin (area under the curve of 4.5 mg/mL per min administered intravenously) or cisplatin (70 mg/ml body surface area administered intravenously) on day 1 of each cycle with either atezolizumab (1200 mg administered intravenously on day 1 of each cycle) or placebo. Group B patients received 1200 mg atezolizumab, administered intravenously on day 1 of each 21-day cycle. The co-primary efficacy endpoints for the intention-to-treat population were investigator-assessed Response Evaluation Criteria in Solid Tumours 1.1 progression-free survival (PFS) and overall survival (OS) (group A vs group C) and OS (group B vs group C), which was to be formally tested only if OS was positive for group A versus group C. The trial is registered with ClinicalTrials.gov, NCT02807636.

Results. Between July 15, 2016, and July 20, 2018, were enrolled 1213patients. 451 (37 %) were randomly assigned to group A, 362 (30 %) to group B, and 400 (33 %) to group C. Median follow-up for survival was 11.8 months (interquartile range 6.1—17.2 months) for all patients. At the time of final PFS analysis and interim OS analysis (May 31, 2019), median PFS in the intention-to-treat population was 8.2 months (95 % confidence interval (CI) 6.5—8.3) in group A and 6.3 months (95 % CI 6.2—7.0) in group C (stratified hazard ratio 0.82; 95 % CI 0.70—0.96; one-sided p = 0.007). Median OS was 16.0 months (95 % CI 13.9—18.9) in group A and 13.4 months (95 % CI 12,0—15.2) in group C (0.83; 95 % CI 0.69—1.00; one-sided p =0.027). Median OS was 15.7 months (95 % CI 13.1—17.8) for group B and 13.1 months (95 % CI 11.7—15.1) for group C (1.02; 95 % CI 0.83—1.24). Adverse events that led to withdrawal of any agent occurred in 156 (34 %) patients in group A, 22 (6 %) patients in group B, and 132 (34 %) patients in group C. 50 (11 %) patients in group A, 21 (6 %) patients in group B, and 27 (7 %) patients in group C had adverse events that led to discontinuation of atezolizumab or placebo.

Conclusion. Addition of atezolizumab to platinum-based chemotherapy as first-line treatment prolonged PFS in patients with metastatic urothelial carcinoma. The safety profile of the combination was consistent with that observed with the individual agents. These results support the use of atezolizumab plus platinumbased chemotherapy as a potentialfirst-line treatment option for metastatic urothelial carcinoma.

Radical cystectomy (RC) remains the main surgical treatment for patients with muscle-invasive bladder cancer. Currently, robot-assisted access is actively used along with the open one. The review analyzes the main results of robot-assisted RC and compares them with those after open RC. We evaluated the following parameters of robot-assisted RC: surgery duration, volume of blood loss, terms of patients’ hospitalization, 30- and 90-day complications. We also compared the results of extra- and intracorporeal urine diversion and found out that intracorporeal ileal conduit formation and orthotopic cystoplasty are more advantageous. Gaining experience allows us to reduce the number of postoperative complications, especially severe ones according to Clavien classification, and to improve the functional results of robot-assisted RC.

Radical prostatectomy and cystectomy with pelvic lymphatic dissection are the most common operations in oncourology. Development of lymphatic complications, such as lymphocele, lymphorrhea and lymphedema, often complicates their implementation. However, not all lymphatic complications manifest themselves clinically and require surgical treatment. There are many risk factors and methods for preventing lymphogenic complications during oncourological operations in the pelvic area. In this article, we will review potential provocative factors that should be considered when performing oncourological interventions in the pelvis, as well as methods for their prevention, which can minimize the lymphogenic complications.

Germ cell tumors are one of the highly sensitive to chemotherapy, and about 80 % of patients can be cured even having metastases. Apartfrom acute toxicity, chemotherapy is characterized by late complications that occur many years later and not only negatively affect the quality of life, but in some cases are life-threatening. The review summarizes the results of studies on the late complications’ occurrence and prevention when treating patients with germ cell tumors.

Objective: to improve the results of treatment of cancer patients with strictures and obliteration of the ureters after surgery and/or remote radiation therapy.

Materials and methods. The study included 6 men and 12 women. The average age of men was 67 + 8.5 years (53—79years) and 46 + 15.8 years (28—74years) among women. According to the results of X-ray examinations, the average length of cicatricial narrowing of the ureter was determined, after which the tactics of surgical treatment were determined.

Results. The duration of surgical treatment rangedfrom 97 to 380 minutes. Intraoperative blood loss in all groups was approximately the same and ranged from 20 to 160 ml. Intraoperative complications occurred in one patient (5.5 %), injury of the intestine. The described damage was repaired by the intracorporeal manual suture. All operations were completed laparoscopically. A generalized indicator of postoperative complications reached 16.7 %. All the complications that occurred had a slight effect on the the rehabilitation period.

Conclusion. The results of this work indicate that ureteroplasty in patients after cancer treatment can be performed by laparoscopic access, which significantly reduces the invasiveness of surgery, reduces the length of hospital stay and rehabilitation of patients. Also, the possibilities of laparoscopic surgery allow you to achieve better visualization, to form more precise sutures.

Nowadays there are several effective drugs to treat castration-resistant prostate cancer. However, treatment options are still limited. In this regard, overcoming the resistance to the prescribed treatment remains extremely important. One possible way is to replace prednisone with dexamethasone when using abiraterone acetate. There are several studies, including randomized ones, which confirm the rationality of this method. We present a literature review and our own clinical observation, which demonstrates the possibility of repeated long-term (3 years) use of abiraterone acetate after replacing a steroid drug in an intensively pre-treated patient with castration-resistant prostate cancer.

Objective: to study the frequency and dynamics of morbidity and mortality in male population of Omsk region with prostate cancerfor the period from 2005 to 2010.

Materials and methods. A retrospective analysis was carried out for the periodfrom 2005 to 2010 of the initial diagnosis of1840patients with prostate cancer and the causes of death of837men in the Omsk region. The contingents of patients with prostate cancer were studied depending on the geographic location, size and composition of the region’s population. The data of the updated base of the population cancer registry and the main reporting forms were used.

Results. There was an increase in the absolute number of diagnosed patients with prostate cancer for the first time by an average of 9.9 % annually. The downward trend was in the number of patients with I—II tumor stage lesions. Stable high annual detection of patients was with stage III (more than 50 %). The advanced forms of prostate cancer accounted for up to 24.4 %. The absolute number of men registered had increased by 52.4 %. The annual mortality rate decreased by an average of 5.7 %. During the monitoring period the absolute number of dead patients increased by an average of 6.7 % annually.

Conclusion. The development and regional implementation of the Program for the early diagnosis and screening of prostate cancer based on a set of simple and generally accessible methods is advisable.