Cancer Urology

The article presents current data on modern approaches to therapy of metastatic castration-resistant prostate cancer with focus on radionuclide methods using Radium chloride, ²²³Ra, and therapy of bone metastases. Data from real clinical practice of using Russian Radium chloride, ²²³Ra, 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, ²²³Ra 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, ²²³Ra in therapy of metastatic castration-resistant prostate cancer, as well as data on its efficacy and safety.

Aim. To evaluate the strategy of temporary interruption of prostate-specific membrane antigen (PSMA)-targeted therapy ¹⁷⁷Lu-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 ¹⁷⁷Lu-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 (¹⁷⁷Lu-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 ²²³Ra therapy had worse prognosis (median PFS 5 months).

Conclusion. Interruption of ¹⁷⁷Lu-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.

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 (р = 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; р = 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. 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.

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 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 m² pre-treatment and 89.1 mL/min/1.73 m² 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. 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. 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 1^st group, robot-assisted RPLND without PCT after orchiectomy was performed (n = 14); in the 2^nd 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 1^st 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 1^st group (2-year observation) was 13.1 ± 1.9 (9.3–16.9) months, in the 2^nd 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.

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.

In 85–95 % of cases, prostate cancer is a multifactorial disease associated with aging and 269 SNPs (single-nucleotide polymorphisms) most of which are located between protein-coding genes and in their introns. The effect of such a number of polymorphisms on disease development is explained by the fact that retroelement genes and non-coding RNA genes evolved from them are located in the SNP areas. As a result, prostate cancer-associated polymorphisms cause changes in retroelement activity leading to the observed epigenetic abnormalities and genomic instability because retroelements induce chromosomal rearrangement. Many studies have shown pathological activation of LINE (long interspersed nuclear elements), SINE (short interspersed nuclear elements) and HERV (human endogenous retroviruses) in patients with prostate cancer. Additionally, retroelements serve as the base of mature long non-coding RNAs involved in disease pathogenesis, and processed retroelement transcripts function as competitive endogenic RNAs. Analysis of scientific literature allowed to describe 22 microRNAs evolved from retroelements and involved in prostate cancer carcinogenesis which can potentially be used as instruments for targeted therapy of the disease.

Prostate cancer is one of the most frequently diagnosed oncological diseases worldwide and in the Russian Federation. Modern extended pelvic lymph node dissection is the most reliable method for detecting metastases in regional lymph nodes in patients with prostate cancer. However, this method is associated with certain risks both during the operation and in the postoperative period, which encourages researchers to develop alternative diagnostic approaches. One such alternative is sentinel lymph node biopsy, which demonstrates high potential in diagnostics. At the same time, a number of factors must be considered: limited number of randomized clinical trials, diversity of protocols used, variability of radioisotope and tracer combinations, as well as the need to consider both instrumental and clinical data. For the widespread implementation of this approach in clinical practice, further scientific research is required, including studies conducted in Russia.

Testicular cancer is a rare malignant tumor of men of working age, with an incidence rate in Russia of less than 2 % per 100,000 people. The aim of our study was to analyze current epidemiological data, modern trends in diagnosis and treatment of germ cell and non-germ cell testicular neoplasms. A literature review was conducted using the PubMed, MEDLINE, Cochrane Library, eLibrary and Scopus databases. Given young age and the necessity to preserve high quality of life in this cohort of patients, timely and accurate diagnosis is important. Self-screening and cancer awareness programs, new biomarkers such as microRNA, circulating tumor DNA, circulating mitochondria DNA, and circulating tumor cells can improve detection of patients with this type of tumor. ¹⁸F-Fluorodeoxyglucose Positron Emission Tomography/Computed Tomography with dual-time-point imaging has high sensitivity and specificity for restaging of residual masses in testicular cancer. Development of new drugs, including immunotherapeutic drugs, can solve the problem of resistance to platinum-based drugs among patients with metastatic cancer. The quality of life of patients with testicular cancer directly depends on the chosen treatment tactics. Therefore, time should always be devoted to psychological preparation and counselling of patients before starting therapy, talking through and discussing all possible short- and long-term complications from the chosen type of treatment.