Background. Maintenance therapy with avelumab is the standard of care for patients with metastatic and locally advanced inoperable urothelial carcinoma who have not progressed with platinum-based chemotherapy. Between 2021 and 2024, 40 patients with metastatic and locally advanced inoperable urothelial carcinoma were treated at the N.A. Lopatkin Research Institute of Urology and Interventional Radiology and the Moscow Center for Immunotargeted Therapy. Their disease was confirmed to be controlled after 4-6 courses of platinum-based chemotherapy followed by maintenance therapy with avelumab. Aim. To evaluate the efficacy and tolerability of maintenance therapy with avelumab in metastatic urothelial cancer in real-world clinical practice. Materials and methods. The study included 11 women (27.5 %) and 29 men (72.5 %), aged 39 to 80 years. Mean age was 63.95 +/- 10.9 years, median age was 65.5 (interquartile range 58.3-72.0 years). Patients were divided by primary tumor location as follows: bladder cancer (24 patients; 60 %), upper urinary tract cancer (14; 35 %), and multiple primary cancer (combined lesions) (2; 5 %). All patients received 4-6 cycles of platinum-based chemotherapy in the first line, with 28 (70 %) patients starting with the gemcitabine + cisplatin combination. Gemcitabine + cisplatin was used throughout treatment in 24 cases (60 %), gemcitabine + carboplatin (30.0 %) was used in 12 cases, and 4 (10 %) patients underwent a switch from gemcitabine + cisplatin to gemcitabine + carboplatin. Chemotherapy resulted in complete response in 6 patients (15 %), while the remaining patients experienced partial response (37.5 %) or stable disease (47.5 %). Progression-free survival (PFS) and overall survival (OS) were analyzed using the Kaplan-Meier method from the start of first-line chemotherapy. A subgroup analysis was performed to assess 12-, 24-, and 36-month PFS, taking into account prognostic factors. Results. The median follow-up was 23.3 months (6 to 54, interquartile range 27.1-45.8 months). Median PFS from the start of chemotherapy was 18 months (95 % confidence interval (CI) not reached-11 months). PFS at 12, 24, and 36 months was 63.2 % (95 % CI 45.9-76.3), 49.3 % (95 % CI 32.5-64.0), and 45.8 % (95 % CI 29.1-61.0), respectively. PFS from the start of avelumab therapy was 14 months. Median OS was not reached at the time of analysis (95 % CI not reached-22 months). OS at 12, 24, and 36 months was 88.9 % (95 % CI 73.1-95.7), 58.3 % (95 % CI 39.5-73.0), and 54.4 % (95 % CI 35.6-69.8), respectively. Better PFS rates were demonstrated in patients with a complete response to platinum-based therapy compared with those with partial response or stable disease, in patients receiving cisplatin compared with carboplatin, in patients with lymph node-only metastases compared with other metastatic sites, and in primary bladder tumors compared with upper urinary tract cancer. Immune-related adverse events were reported in 50 % of patients, but only in 7.5 % (n = 3) of cases did these lead to avelumab discontinuation. Therapy interruption occurred in 1 patient. Conclusion. Real-world clinical practice has demonstrated that maintenance therapy with avelumab is an effective strategy for long-term disease control in patients with metastatic and locally advanced inoperable urothelial cancer, with an acceptable immune-mediated toxicity profile.
Background. The decade-long use of checkpoint inhibitors in real-world clinical practice in Russia allowed to treat hundreds of patients with urothelial malignancies. The AURORA-RU Phase IV observational Russian study was initiated to evaluate the efficacy of atezolizumab in patients with urothelial carcinoma resistant to platinum-based chemotherapy. This article is based on an analysis conducted at a median follow-up of 60.7 months and provides data on treatment efficacy in Russian patients receiving second-line and subsequent lines of systemic therapy. Aim. To evaluate the clinical efficacy of atezolizumab monotherapy in patients with urothelial carcinoma of the upper and lower urinary tract progressing on platinum-based chemotherapy in a real-world clinical setting. The primary endpoints were progression-free survival (PFS) and overall survival (OS). Secondary endpoints included subgroup analyses of efficacy based on the line of therapy (including the subgroup with early progression after neo/adjuvant chemotherapy [NACT/ACT]), age cohort, metastatic sites, and primary tumor location (bladder vs. upper urinary tract). Materials and methods. The study included data from 152 patients with verified muscle-invasive locally advanced and metastatic urothelial carcinoma who received PD-L1 inhibitor (atezolizumab) monotherapy across 13 centers in the Russian Federation between 2019 and 2025. Atezolizumab treatment was administered to patients who progressed on platinum-based chemotherapy. More than half of the patients (55.9 %) were over 65 years of age. The cohort consisted of 75.0 % men and 25.0 % women. The majority of patients (78.3 %) had a primary tumor located in the bladder. PD-L1 inhibitor therapy was administered as second-line treatment in 57.9 % of cases, while one in five patients (21.7 %) received third-line treatment. In 86.8 % of cases, treatment was administered without prior assessment of PD-L1 expression levels. Results. In the overall cohort, the median PFS reached 5.5 months, with 36-month and 48-month PFS rates of 15.9 % and 9.9 %, respectively. The median OS was 12.0 months; 21.9 % of patients survived 3 years, and 14.3 % of patients remained under observation for five years. In patients transitioning to immuno-oncology treatment after rapid progression following NACT/ACT, the median OS was 17.4 months. The median OS for second-line therapy was two-fold higher than for third-line therapy: 13.9 months versus 6.1 months. High treatment efficacy was noted in patients over 70 years of age (median PFS of 8.7 months; median OS of 14.9 months). Conclusion. In real-world practice, PFS and OS rates were comparable to those reported in registration trials and other real-world evidence studies. The lack of PD-L1 expression testing generally did not affect the efficacy of immuno-oncology therapy in patients with urothelial carcinoma.
Aim. To determine clinical and morphological characteristics of the tumors invisible on magnetic resonance imaging (MRI) in patients with prostate cancer (PCa) who underwent robot-assisted radical prostatectomy. Materials and methods. Retrospective analysis of MRI images of 151 patients with PCa after robot-assisted radical prostatectomy between 2022 and 2023 was performed. Series of T2-weighted, diffusion-weighted and dynamic contrast-enhanced images in accordance with the PI-RADS v.2.1 (Prostate Imaging Reporting and Data System) protocol were obtained. All MRI scans were interpreted by two radiologists with more than 20 years of experience. Statistical analysis was performed using IBM SPSS Statistics 25.0 software. Results. Among 151 patients of the study cohort, 25 (17 %) patients did not have PI-RADS 3-5 lesions, while 126 (83 %) had them (& rcy; = 0.121). The patients had statistically significant differences in the prostate-specific antigen levels: in the group with lesions confirmed by multiparametric MRI (mpMRI) compared to the group without lesions the level of this tumor marker was significantly higher (median 7.15 [5.0-11.6] ng/mL; 95 % confidence interval (CI) 8.51-11.86 and 5.9 [4.13-8.1] ng/mL; 95 % CI 4.19-12.05, respectively; & rcy; = 0.034). The incidence of tumors with Gleason score 6 and 7 depending on the type of prostate cancer on mpMRI was determined. For focal lesions, the incidence of neoplasms with Gleason score 7 was higher (n = 92) than in the group without lesions (n = 14). Prostatic lesions per mpMRI were significantly more common in patients with potentially more aggressive forms of PCa (high prostate-specific antigen level, Gleason score >= 7, high tumor volume per morphological examination). In the absence of confirmed prostatic lesions by mpMRI, in 72 % of patients, tumor volume did not exceed 37.5 % of the resected organ per morphological examination. Additionally, in this case less aggressive characteristics and smaller volume of the tumor were observed compared to lesional disease. Conclusion. The results confirmed high incidence of aggressive forms of the disease in MRI-visible PCa. In the group of MRI-invisible tumors, more than half of neoplasms had Gleason score 7. These data do not allow to unequivocally classify patients with MRI-invisible cancer into the favorable prognosis group.
Background. Bladder cancer (BC) is one of the most common cancers worldwide, representing an urgent problem of modern oncology. Various external and internal environmental factors increase the disease risk. Genetic susceptibility to BC is unquestioned and actively researched nowadays. Aim. To analyze current advances in genetic factors of BC and to assess the prospects for further research in this area. Materials and methods. A systematic analysis of modern literature available in the PubMed database was conducted. Results and conclusion. A small part of BC cases is associated with hereditary syndromes, which are characterized by BC development. Genes regulating cellular metabolism, DNA repair, and cell cycle are associated with BC. Today, there is a clear understanding that high-risk genes are rarely involved in the development of most BC cases, but there are many polymorphic loci with low penetrance and moderate effects that acting together increase BC risk, indicating a complex polygenic inheritance pattern for this disease.
Background. Non-clear cell renal cell carcinoma (nRCC) is a heterogeneous group of malignancies, accounting for approximately 15-20 % of all kidney tumors. Results of the KEYNOTE-B61 phase II trial demonstrated high antitumor activity and a favorable safety profile for the combination of lenvatinib and pembrolizumab in patients with nRCC. Due to these clinically significant results, the combination of lenvatinib and pembrolizumab has been included in international and Russian guidelines, becoming the preferred first-line treatment for metastatic nRCC. Aim. To confirm the efficacy of the combination of lenvatinib and pembrolizumab in real-world clinical practice at the Leningrad Regional Clinical Hospital in patients with nRCC. Materials and methods. In this study, we conducted a retrospective analysis of real-world clinical data describing 10 patients with nRCC treated with combination therapy of lenvatinib and pembrolizumab. Results. The objective response rate was 40 %, including 10 % of complete responses. Median progression-free survival was not achieved (follow-up 36-49 months for most patients). At the last follow-up, all patients remained progression-free. No new safety signals were identified. Conclusion. The experience of the Leningrad Regional Clinical Hospital with the combination of lenvatinib plus pembrolizumab for the treatment of nRCC has confirmed its efficacy and safety in real-world clinical practice in a Russian patient cohort. The safety profile was predictable and manageable, with no treatment-related lethal outcomes. These findings support that the combination of lenvatinib plus pembrolizumab should be considered a standard first-line therapy for patients with advanced nRCC.
Background. Prostate cancer is the most common cancer among men in Russia. Despite the successes of local treatment, the risk of biochemical recurrence (BR) persists and requires long-term monitoring of prostate-specific antigen (PSA). Patient compliance is a crucial factor of timely recurrence diagnosis. Aim. To evaluate cognizance and adherence to outpatient treatment in patients with local and locally advanced prostate cancer after local treatment in Russia. Materials and methods. Two-stage study was performed: survey of 22 oncologists from 18 centers and telephone survey of 2046 patients from 10 oncological centers who received local treatment in 2022. Original questionnaires were used. Statistical analysis was performed using the Statistica 10 software. Results. The majority of patients (99.2 %) are informed about the necessity of PSA level monitoring. However, 36.8 % did not know threshold PSA levels, 18.7 % did not undergo examination in a timely manner, and 4.3 % weren't informed on the timeframes of monitoring. BR was diagnosed in 11.43 % of patients. Among them, in 16.2 % clinical recurrence was detected due to late BR diagnostics and belated visit to an oncologist. However, no statistically significant correlation between cognizance level, examination regularity with development of clinical recurrence was found (p >0.05). In 39.3 % of cases, treatment of prostate cancer due to diagnosed BR was delayed. Conclusion. Despite high general cognizance, significant deficit of practical knowledge and low adherence to regular monitoring were observed. To decrease the number of clinical recurrences developed due to delayed start of treatment after BR, comprehensive approach is necessary consisting of patient briefing and optimization of control methods at the medical facilities performing outpatient observation.
The article presents current data on modern approaches to therapy of metastatic castration-resistant prostate cancer with focus on radionuclide methods using Radium chloride, Ra-223, and therapy of bone metastases. Data from real clinical practice of using Russian Radium chloride, Ra-223, manufactured by Prostor Pharma LLC to which Russian healthcare facilities gradually transitioned due to import phase-out in 2024-2025 are summarized. Russian Radium chloride, Ra-223 manufactured by Russian company Prostor Pharma LLC is completely identical to the original drug in terms of composition, formulation, medical indications. Currently, 37 institutions work with this drug including 6 new centers opened in 2025 which allowed many patients to receive highly effective treatment in their region. According to the data from Russian clinics, the drug was mainly prescribed in the 2nd therapy line per clinical guidelines of the Association of Oncologists of Russia. However, in many patients the "therapeutic window" was missed which led to decreased number of courses and lower treatment efficacy. The article presents a review of international and Russian clinical trials of the use of Radium chloride, Ra-223 in therapy of metastatic castration-resistant prostate cancer, as well as data on its efficacy and safety.
Germ cell tumors are malignant tumors that develop from germinal cells. Over 90 % of all germ cell tumors in men are represented by germ cell seminomas. The incidence of choriocarcinoma does not increase with age but reaches its peak among people aged 25 to 34 years. A clinical case of surgical treatment of metastatic testicular choriocarcinoma with simultaneous nephrectomy, retroperitoneal lymph node dissection, prosthesis of the inferior vena cava and the infrarenal aorta is presented. The most serious complication in this group of patients is prosthetic infection. The implemented stage-by-stage multidisciplinary treatment approach allowed to achieve a good oncological and functional result.
Aim. To evaluate the efficacy, safety, and feasibility of dd-MVAC (methotrexate, vinblastine, doxorubicin, cyclophosphamide) chemotherapy in real-world clinical practice. Materials and methods. Patients were enrolled between September 2022 and May 2025. They were scheduled to receive six cycles of neoadjuvant dd-MVAC chemotherapy, supported by granulocyte colony-stimulating factor from day 4 to day 9 of each cycle, repeated every two weeks. Eligible patients had urothelial bladder cancer staged as cT2-4a, N0-3, M0, with creatinine clearance of >= 50 mL/min. The primary endpoint was the pathological complete response (pCR) rate. Secondary endpoints included toxicity, the number of treatment cycles completed, and pathological response. Results. The study included 40 patients. Of these, 87 % (n = 35) completed six cycles of dd-MVAC, while 8 % (n = 3) and 5 % (n = 2) completed five and four cycles, respectively. Full protocol drug doses were administered to 57 % of patients (n = 23), while a 15 % dose reduction was required in 43 % (n = 17). The majority of these dose reductions (59 %, n = 10) were implemented after the fifth cycle. The most frequent grade 3 adverse events (per Common Terminology Criteria for Adverse Events (CTCAE) v.5.0) were hematological: neutropenia in 40 % (n = 16), anemia in 10 % (n = 4), and thrombocytopenia in 10 % (n = 4). One fatal case of febrile neutropenia occurred. The most common grade 1-2 adverse event was asthenia reported in 80 % (n = 32) of patients. Surgical treatment was performed in 80 % (n = 32) of the cohort. Cystectomy was conducted in 91 % (n = 29) of these surgical patients, while organ-preserving surgery was performed in 9 % (n = 3). A complete pathological response (ypT0pN0) was achieved in 53 % (n = 17) of surgically treated patients, and downstaging to 3pN0 was observed in 9 % (n = 3). Disease stabilization was reported in the remaining 38 % (n =12). No significant decline in renal function was observed; median glomerular filtration rate was 80.4 mL/min/1.73 m(2) pre-treatment and 89.1 mL/min/1.73 m(2) post-treatment. Conclusion. The dd-MVAC regimen is an effective and feasible neoadjuvant therapy for muscle-invasive bladder cancer, enabling the majority of patients to complete the full preoperative course of chemotherapy.
Background. According to primary orchiectomy data, up to 50-60 % of testicular germ tumors are seminomas. For stage IIA and IIB seminomas, radiotherapy (RT) and polychemotherapy (PCT) are generally accepted treatment standards with excellent 5-year survival up to 99 %. Despite high treatment efficacy, PCT and RT are accompanied by significant toxic effects which can severely decrease patients' quality of life. Aim. To evaluate efficacy and safety of retroperitoneal lymph node dissection (RPLND) as a first stage of treatment after orchiectomy as an alternative to PCT and RT. Materials and methods. In total, 24 patients with stage IIA/B testicular seminomatous germ cell tumors without RT were selected. The patients were divided into groups: in the 1st group, robot-assisted RPLND without PCT after orchiectomy was performed (n = 14); in the 2nd group, PCT per the BEP scheme (bleomycin + etoposide + cisplatin) with subsequent laparoscopic RPLND after orchiectomy was performed (n = 10). In both groups, complications per the Clavien-Dindo classification, operative time, blood loss volume, hospital days, recurrence-free survival, presence of ejaculation after RPLND, histological conclusion, PCT toxicity were assessed. Results. Mean patient age was 38 years. Patient distribution per disease stage: 18 (75.0 %) patients with stage IIA, 6 (25.0 %) patients with stage IIB. There were no intraoperative vascular complications, no transition to laparotomy. Mean operative time was 267 +/- 19.4 min. Mean blood loss volume was 174 +/- 25 mL. Mean hospital days were 8 days. No significant postoperative complications (severity grade >= IV per the Clavien-Dindo classification) were reported. In the late postoperative period, 2 patients required surgical treatment for lymphorrhea in the form of transcutaneous translumbar puncture with embolization of the lymph ducts under the control of flat detector computed tomography. Mean number of resected lymph nodes was 27.1. Viable tumor was verified in 2 (8.3 %) patients of the 1st group. Functional results: retrograde ejaculation in 11 (45.8 %) cases (in group 1: 3 (21.4), in group 2: 8 (80.0); p = 0.01). Recurrence-free survival in the 1st group (2-year observation) was 13.1 +/- 1.9 (9.3-16.9) months, in the 2nd group (observation from 2013 to 2025), 57 +/- 5.7 (11.0-116.8) months. None of the patients had signs of recurrence per clinical, instrumental or laboratory data. Conclusion. Prophylactic RPLND decreases the risk of recurrence and progression of germ line testicular tumors and allows to avoid risks of delayed toxicity associated with PCT and RT. In patients with stage IIA/B seminomas and low volume of residual retroperitoneal masses, RPLND provides good prognosis with minimal risks of treatment continuation in the future.
Aim. To evaluate the strategy of temporary interruption of prostate-specific membrane antigen (PSMA)-targeted therapy Lu-177-PSMA. Materials and methods. A retrospective observational study was conducted which included 30 patients divided into two groups: treatment group (n = 16) received 2 to 4 fractions of Lu-177-PSMA and switched to observation ("holiday'), and control group (n = 14) completed the standard 6 fractions. Prostate-specific antigen (PSA) reduction rates, progression-free survival (PFS), adverse event rate, and effect of combination therapy (Lu-177-PSMA + enzalutamide) were evaluated. Results. In the first group, a decrease in PSA by more than 50 % was observed in 100 % of patients, in the second group in 92.3 %. The median PFS was 8 months in the first group and 6 months in the second. No serious adverse events (> grade II) were observed. Combination with enzalutamide was associated with improved PFS (median 12 months vs 6 months). Patients with poorly differentiated tumors (Gleason >= 9) and previous Ra-223 therapy had worse prognosis (median PFS 5 months). Conclusion. Interruption of Lu-177-PSMA therapy after 2-4 fractions with subsequent continuation in case of progression is a promising strategy that allows balancing between efficacy and safety. This approach is especially relevant for patients with limited metastatic burden and high risk of hematological toxicity. However, given the limited and heterogeneous patient sample, a detailed study in a larger patient cohort is necessary.
Background. Survival rate calculation remains the key metric in evaluating the performance of cancer care systems. In Russia, only a limited number of administrative regions possess the infrastructure to reliably perform such assessments. The first population-based cancer registry in Russia, established by our team in 1993 and operating in accordance with international standards, significantly expanded these capabilities to the level of a federal district. Utilizing data from the population-based cancer registry of the Northwestern Federal District (NWFD), we currently conduct research reflecting the real state of cancer care delivery in the country. Aim. To analyze survival trends in patients with bladder cancer (BC) in the NWFD of Russia and to assess current therapeutic approaches. Materials and methods. The study was based on a population-based cancer registry dataset comprising over 1.6 million cases, including 31,126 patients diagnosed with BC. Data were processed using standard methods in line with the Eurocare protocols. Results. A marked increase in one-year observed survival was found: from 68.7 % to 75.5 %; as well as in five-year survival: from 42.8 % to 48.4 %. Overall mortality during the observation period declined from 31.3 % to 24.5 %. Among patients under 40 years of age, one-year survival exceeded 90 %, while in the elderly and long-lived cohorts it remained below 50 %. The proportion of patients diagnosed with localized BC increased from 46.9 % to 70.4 %, whereas the rate for advanced disease reached 39.0 %. Patients with stage IV urothelial carcinoma demonstrate the poorest survival outcomes, which is consistent with international epidemiological data. The advent of immunotherapy and targeted agents has marked a new era in the management of the disease, showing improvement in long-term outcomes in selected patient subgroups. Conclusion. The data demonstrate a positive trend in one-year survival among BC patients in the NWFD of Russia, particularly in those diagnosed with localized disease. The improvement in stage distribution and a reduction in unspecified tumor localizations indicate enhanced diagnostic accuracy and higher quality of oncological care.
Darolutamide is a high-affinity second-generation antiandrogen, the effectiveness and favorable safety profile of which have been proven two phase III randomized clinical trials (RCTs) in metastatic hormone-sensitive prostate cancer (mHSPC) as part of a triple combination with docetaxel and androgen deprivation therapy (ADT) (ARASENS), as well as non-metastatic castration-resistant prostate cancer in the composition double combination with ADT (ARAMIS). Positive results have now become available from another phase III RCT ARANOTE, aimed at comparing the efficacy of the double combination of darolutamide with ADT and placebo with ADT in patients with mHSPC. Darolutamide significantly prolonged radiological progression-free survival, reducing the risk of radiological progression or death by 46 % compared with placebo (primary endpoint), also provided benefit of secondary study endpoints, including time to castration resistance and time to pain progression. The clinical benefit of darolutamide in primary and secondary points was realized regardless of the volume of metastatic load. Data on overall survival is immature. The incidence of adverse events was low and similar in the darolutamide and placebo groups, with a lower incidence of fatigue in the darolutamide group. The obtained data on the effectiveness of darolutamide with ADT in mHSPC are comparable with the results of similar studies of other second-generation antiandrogens enzalutamide (ARCHES phase III RCT) and apalutamide (TITAN phase III RCT). Potentially, the combination of ADT with darolutamide could claim a place in the list of standard treatment methods and expand therapeutic options for patients with mHSPC.
Background. Prostate cancer remains the leading malignancy among men. The status of patients initially diagnosed with a Gleason score of (3 +3) 6 based on biopsy results is becoming increasingly questioned. Can ISUP 1 be considered "NOTcancer"? Various additional diagnostic methods can be the key not only to establishing a prostate cancer diagnosis, but also to predicting the grade of cancer differentiation at the pre-invasive stage. Aim. To assess the correspondence between biopsy and postoperative Gleason scores in patients with Gleason 3 + 3, and to study the pathological characteristics of true ISUP 1. Materials and methods. The study analysed data from 225 patients who underwent radical prostatectomy between 2018 and 2024. The average patient age was 65 +/- 6 years, median prostate-specific antigen level was 8.7 ng/mL, and median prostate volume was 55 cm3. All patients initially had a biopsy Gleason score of 3 + 3. Histological examination of surgical specimens was performed in accordance with national clinical guidelines. Results. In 54.22 % of patients, the postoperative Gleason score increased to >= 7. ISUP groups 4 and 5 were identified in 4.89 % of cases, and pattern "5" was found in 1.33 % of patients. In all true ISUP 1 cases (45.78 %), characteristic pathological features of cancer were identified. Conclusion. True ISUP 1 has all the morphological characteristics of cancer. More than half of the patients with a biopsy Gleason score of 3 + 3 had a higher final Gleason score upon histological examination. This confirms the need to improve existing diagnostic and treatment approaches for this patient category.
Background. Biopsy is the standard for prostate cancer (PCa) diagnostics. The false negative rate of 12-core biopsy is about 30 %. To improve the quality of detection of clinically significant PCa (csPCa) (ISUP (International Society of Urological Pathology) score 2 or more) during repeat biopsy, it is possible to use targeted diagnostic methods, such as HistoScanning (HS), cognitive fusion biopsy, hardware fusion biopsy. Aim. To compare targeted prostate biopsy methods: HS, cognitive fusion, hardware fusion biopsy for the diagnosis of csPCa during repeat biopsy in patients with negative primary biopsy result. Materials and methods. A prospective comparative study was conducted. The study included 320 men with suspected PCa after negative primary biopsy. Median age was 68 years, PSA level was 9.1 ng/mL, prostate volume was 57 cm2, PSA density was 0.15 ng/ml/cm2. Patients were divided into three groups depending on repeat biopsy method: group 1 – HS, group 2 – cognitive fusion biopsy, group 3 – hardware fusion biopsy; the groups were comparable with each other. Results. PCa was diagnosed after repeat biopsy using HS, cognitive fusion, hardware fusion biopsy in 25.4, 45.5, 44.2 % of cases, respectively; csPCa was diagnosed in 4.5, 22.2, 18.2 % of cases, respectively. In all groups, PCa and csPCa were most often diagnosed with lesions in both target and standard biopsies. The use of targeting in the HS group did not provide an advantage in diagnostics. In the hardware fusion biopsy group, in the absence of cancer in standard cores, csPCa was diagnosed more often in targeted biopsies, compared with the cognitive fusion technique (11.8 % versus 7.5 %). With both fusion biopsy techniques, more malignant forms of PCa were diagnosed in targeted biopsies, compared with standard cores, however, due to standard cores, 23.5 % of PCa cases were not missed, of which 3.75 % were csPCa. The use of transrectal cognitive fusion technique showed a comparable result with perineal hardware fusion biopsy for diagnosing transition zone cancer. Conclusion. The HS technique did not show advantages in diagnosing PCa during repeat biopsy. The use of cognitive fusion and hardware fusion techniques allows to improve diagnostics of both PCa and csPCa during repeat biopsy. According to our data, it is recommended to use targeted cores in addition to the standard ones. The use of cognitive fusion biopsy showed comparable results with hardware fusion in diagnostics of transition zone prostate cancer.
Background. Assessment of oncological care in the Russian Federation requires reliable and accurate data. A significant step in this direction was taken in 1996 with the issuance of Order No. 420 of the Ministry of Health of the Russian Federation dated December 23, 1996, “On the Creation of the State Cancer Registry”. However, despite this, information databases (DBs) are still underutilized in analytical calculations of most indicators (except for incidence rates). The only exception is the data obtained from the first Population-Based Cancer Registry (PBCR) in Russia established in Saint Petersburg in 1993 which now covers the entire Northwestern Federal District (NWFD) of the Russian Federation. Aim. Based on the extensive database of the PBCR NWFD of the Russian Federation, this study aims to conduct a comparative analysis of cancer registry data and official state reports on one-year mortality rates in patients with bladder cancer (BC). Additionally, it seeks to present detailed description of BC location and histological structure in this patient group and analyze modern diagnostic capabilities for malignant neoplasms of the bladder. Materials and methods. The study is based on a verified database of the PBCR NWFD of the Russian Federation, containing data on more than 31,000 BC patients. Standard oncological statistical methods were applied in the analysis. Results. A decline in the one-year mortality rate among BC patients in the NWFD of the Russian Federation was observed, decreasing from 31.3 % in 2000–2004 to 24.5 % in 2020–2022. Significant changes in tumor locations were noted: the proportion of BC cases (C67.0) in the bladder trigone decreased from 14 to 7.7 %, while the proportion of tumors in the lateral wall (C67.2) increased from 4.1 to 22.1 %. Additionally, there was a rise in cases of unspecified location (C67.9). However, histological structure of BC, classified according to the WHO codes, remained practically unchanged. Conclusion. A positive trend in the reduction of one-year mortality rates among BC patients has been identified. Modern diagnostic methods for BC have been presented highlighting the need for further development of cancer registries to enhance monitoring and assessment of the quality of oncological care in the Russian Federation.
Background. Advancements in digital technologies have revolutionized surgical education. One such innovation is the remote mentor technology, which enables experienced surgeons to assist less experienced colleagues in real time using mixed reality and telecommunication tools. Aim. To develop a remote mentoring system and assess its usability during laparoscopic partial nephrectomy from both the trainee and the mentor perspectives. Materials and methods. Ten laparoscopic partial nephrectomies were performed using augmented reality and the Remote Mentor system. After each surgery, both mentors and trainees completed structured questionnaires assessing the quality of audiovisual exchange, interface intuitiveness, and communication completeness. The system used Hololens II and cloud-based software. Data were analyzed using non-parametric tests and correlation analysis. Results. The median age of trainees was 36.5 years; mentors – 60 years. All participants rated the system highly, with no negative responses recorded. Significant positive correlations were found between operator age/experience and satisfaction scores. The system demonstrated strong technical performance and high subjective efficacy. Conclusion. The remote mentoring system presents a promising tool for expanding access to surgical training. It showed high user satisfaction and technical feasibility. However, further validation with larger randomized studies is necessary.
Background. Prostate cancer remains the leading malignancy among men. The status of patients initially diagnosed with a Gleason score of (3 + 3) 6 based on biopsy results is becoming increasingly questioned. Can ISUP 1 be considered “NOTcancer”? Various additional diagnostic methods can be the key not only to establishing a prostate cancer diagnosis, but also to predicting the grade of cancer differentiation at the pre-invasive stage. Aim. To assess the correspondence between biopsy and postoperative Gleason scores in patients with Gleason 3 + 3, and to study the pathological characteristics of true ISUP 1. Materials and methods. The study analysed data from 225 patients who underwent radical prostatectomy between 2018 and 2024. The average patient age was 65 ± 6 years, median prostate-specific antigen level was 8.7 ng/mL, and median prostate volume was 55 cm3. All patients initially had a biopsy Gleason score of 3 + 3. Histological examination of surgical specimens was performed in accordance with national clinical guidelines. Results. In 54.22 % of patients, the postoperative Gleason score increased to ≥7. ISUP groups 4 and 5 were identified in 4.89 % of cases, and pattern “5” was found in 1.33 % of patients. In all true ISUP 1 cases (45.78 %), characteristic pathological features of cancer were identified. Conclusion. True ISUP 1 has all the morphological characteristics of cancer. More than half of the patients with a biopsy Gleason score of 3 + 3 had a higher final Gleason score upon histological examination. This confirms the need to improve existing diagnostic and treatment approaches for this patient category.
Population of the patients with prostate cancer N1M0 is heterogenous, and their treatment requires the use of risk-adapted approach. In case of clinically positive lymph nodes (cN1): choice option: external beam radiation therapy (EBRT) with long-term adjuvant androgen deprivation therapy (ADT) (36 months) and abiraterone with prednisolone (24 months); alternative: radical prostatectomy (in case of 1–2 enlarged regional lymph nodes and ISUP (International Society of Urological Pathology) grade 1–3) with possible subsequent prescription of ADT with or without EBRT depending on the presence of risk factors; in case of short life expectancy: immediate ADT in combination with abiraterone acetate and prednisolone or delayed ADT (depending on the presence of symptoms and expected duration of survival). In cases of histologically verified metastases in the regional lymph nodes (pN1): choice option: immediate constant lifetime adjuvant ADT; alternative if postoperative prostate-specific antigen level 0.1 ng/mL or 3 positive lymph nodes: dynamic observation; alternative in the presence of risk factors (category pT ≥T3b, Gleason score 9–10, R1) and ≥3 positive lymph nodes: adjuvant EBRT and ADT. Development of the optimal risk-adapted approach requires well-planned randomized clinical trials with adequate stratification and endpoints using high-fidelity diagnostic techniques, modern EBRT methods and new antitumor drugs.
