Urologic Neoplasms

The main purpose of this study is to see how well vepugratinib works in adults with low grade, intermediate risk, non-muscle invasive bladder cancer (LG IR NMIBC) or low-grade upper tract urothelial carcinoma (LG UTUC). Safety tests will also be conducted. For each participant, the study will last up to 5 years.

BEACON (Benchmarking AI for Clinical Oncology decisioNmaking) is a prospective, multicentre, comparative, blinded, non-interventional benchmark comparing the treatment recommendations of six frontier large language models (LLMs) with those of multidisciplinary tumour boards (RCP) in oncology treatment planning. One hundred standardised synthetic cases (20 per localisation, across breast, lung, urological, digestive and gynaecological cancers) are submitted as identical structured input to two independent tumour boards per localisation and to six frontier LLMs. Every recommendation, human or model, is decomposed into five predefined decision domains (intent, surgery, radiotherapy, systemic therapy with its line, work-up and biomarkers). For each domain, concordance between two recommendations is scored 2 when the same options are selected, 1 when at least one option is shared, and 0 when none is shared; the score is computed automatically from the recommendation forms, without human scoring. The primary endpoint is the mean domain score between each LLM and each tumour board, read against the same score computed between the two tumour boards of the same case, so that humans and models are measured by an identical rule and no respondent contributes to its own reference. A co-primary safety endpoint captures the proportion of recommendations carrying serious harm potential, because concordance alone can conceal dangerous errors. Where the two boards select different options, the case-domain is classified EQUIPOISE and, like every discordance, is adjudicated by an independent panel blinded to the source of the recommendation. Tumour boards record their recommendations during the meeting itself, on a dedicated platform (https://etude-beacon.fr) that reveals a case only once it is presented and time-stamps that reveal, so that no board can read a case in advance. BEACON is designed as reusable, openly licensed, pre-registered infrastructure: all synthetic cases, evaluation rubrics, scoring algorithms, verbatim prompts and raw model outputs are released for full reproducibility.

Study Design Prospective, single-arm, multicenter clinical study. Study Drugs Neoadjuvant phase: QL1706 (Aipaluo Tuoworilimab, an anti-PD-1/CTLA-4 combination antibody) plus lenvatinib. Adjuvant phase: QL1706 monotherapy. Target Population Patients with high-risk localized or locally advanced clear cell renal cell carcinoma (ccRCC) meeting AJCC staging criteria (e.g., cT3a G3-4 cN0M0, etc.) who are candidates for neoadjuvant therapy and surgical resection. Treatment Flow Screening (28 days): Informed consent obtained, baseline assessments completed. Neoadjuvant phase (4 cycles, 21 days/cycle): QL1706 5 mg/kg IV, Q3W; plus oral lenvatinib 12 mg QD. Efficacy evaluation every 2 cycles; surgery after 4 cycles (unless early termination). Adjuvant phase (13-17 cycles, 21 days/cycle): Eligible patients continue QL1706 5 mg/kg IV, Q3W. Imaging every 3 months until recurrence, new therapy, death, or completion of 21 cycles total. Follow-up: Safety follow-up (90 days after last QL1706 dose or 30 days after last other drug, whichever is longer), then survival follow-up every 90 days. Endpoints Primary: Objective response rate (ORR) per RECIST 1.1. Secondary: Pathological complete response rate (pCR), median disease-free survival (mDFS), 12-/24-month DFS rates, median overall survival (mOS), and safety. Sample Size Planned enrollment: 54 subjects.

DNA methylation changes occur early and broadly during carcinogenesis. Methylscape is a rapid assay that detects global DNA methylation patterns in body fluids (blood, urine, and saliva) and may detect a cancer signal and predict the cancer signal origin (CSO) from a single fluid sample, using the differential interaction between methylated and unmethylated DNA and gold nanoparticles. This prospective observational study evaluates the diagnostic performance (sensitivity and specificity) of the Methylscape test in Colombian patients with various biopsy-confirmed solid tumors compared with age- and sex-matched cancer-free (healthy) volunteers. The study is conducted in three parts: Phase 1 validates the assay in 250 patients with cancer; Sub-study 2a compares 1,500 patients with cancer against 1,500 matched cancer-free volunteers; and Sub-study 2b uses serial blood and urine sampling in 300 patients with early-stage disease to assess detection of disease relapse during follow-up, in parallel with standard imaging. The study also estimates positive and negative predictive values (PPV/NPV) and projects the budget impact and cost-effectiveness of Methylscape as a multi-cancer early detection (MCED) tool in an upper-middle-income Latin American setting.

Open simple prostatectomy is still performed for selected patients with benign prostatic hyperplasia, particularly in cases with large prostate volume. Postoperative bleeding, hematuria, clot retention, and transfusion requirement are clinically important complications after this procedure. This prospective randomized controlled trial will compare the effects of spinal anesthesia and general anesthesia on postoperative bleeding in patients undergoing open simple prostatectomy. Participants will be randomized into two groups: spinal anesthesia or general anesthesia. Tranexamic acid or any additional hemostatic agent will not be used. Postoperative bleeding will be assessed using hemoglobin and hematocrit changes, transfusion requirement, hematuria, clot retention, need for bladder irrigation, and bleeding-related reintervention. The study aims to determine whether spinal anesthesia is associated with reduced postoperative bleeding compared with general anesthesia in open simple prostatectomy.

Spinal anesthesia-induced hypotension is a common and clinically significant complication in elderly patients undergoing oncologic surgery. Early identification of patients at risk for hemodynamic instability remains a major challenge in perioperative management. Skin conductance reflects sympathetic nervous system activity and may provide a noninvasive indicator of autonomic responses. This prospective observational study aims to evaluate whether skin conductance measurements can predict the development of hypotension following spinal anesthesia in geriatric oncology patients undergoing urologic surgery. The findings may contribute to improved perioperative monitoring and early risk stratification in this vulnerable patient population.

The aim of this study is to establish and optimize the \[18F\]RCCB6 PET/CT imaging method, and its physiological and pathological distribution characteristics, on the basis of which the diagnostic efficacy of the above imaging agent in renal cancer (especially clear cell renal cell carcinoma) wil be evaluated.

This is a single-armed, single-centre, non-blinded phase II trial to assess efficacy of induction chemo-immunotherapy for resectable node-positive squamous cell carcinoma of the penis

This is a multicenter real world study (RWS) initiated by the investigator. Eligible patients will be selected for treatment with second-line treatment including vorolanib and followed up. The real survival data of patients after medication will be collected and compared with the data of CONCEPT study, and multi-factor stratified analysis of the efficacy of voronib will be conducted.

The purpose of this study is to examine the usefulness of implanting small 24-K gold fiducial markers around a bladder tumor site, so that a Radiation Oncologist can identify the original tumor location at the time of radiation treatment. Other goals of the study include assessing whether a new MRI imaging technology can help with detection of bladder cancer earlier and more accurately when evidence of bladder cancer is not visible by scope.