Urologic Cancer

This prospective multicenter observational study aims to evaluate the predictive value of artificial intelligence-based analysis of preoperative 12-lead electrocardiography for myocardial injury after non-cardiac surgery (MINS) and major adverse cardiovascular events (MACE) within 30 days after surgery in patients undergoing non-cardiac surgery for urologic cancer.

A short bolus infusion of fluid, called "fluid challenge" is commonly recommended for fluid treatment during longer surgery. However a prolonged increase of the blood volume is a prerequisite to recommend the technique. The purpose with the study is to examine the plasma expanding effect of three different fluid challenge strategies (acetated Ringers 4 ml/kg body weight, albumin 5% 4 ml/kg body weight or albumin 20% 1 ml/kg body weight), using hemoglobin as a dilution indicator.

The goal of this clinical trial is to learn whether extracellular vesicles (EVs) in the blood can be used as biomarkers to predict chemotherapy-induced peripheral neuropathy (CIPN) in adult cancer patients receiving chemotherapy with taxanes, platinum compounds, or antimitotic drugs. The main questions the study aims to answer are whether blood levels of EVs change in patients who develop CIPN during and after chemotherapy and whether specific features of EVs, including lipids and microRNAs, are associated with the development and severity of CIPN. Participants will be followed from before the start of chemotherapy until six months after treatment ends to evaluate how changes in EVs relate to nerve damage caused by chemotherapy. During the study, participants will provide blood samples before chemotherapy, at the end of treatment, and six months later for measurement and molecular analysis of EVs, will complete questionnaires about neuropathy symptoms, and will undergo simple, non-invasive nerve function tests using a tuning fork (diapason) and a Neuropen device. This study does not test cancer drugs; instead, it aims to identify biological markers in blood that may help predict which patients are at higher risk of developing CIPN, with the goal of improving monitoring and care during cancer treatment.

This is an open-label, expanded access trial designed to provide access to cretostimogene in patients with NMIBC (specifically CIS with or without HG Ta/T1) unresponsive to BCG.

Study REL-NDV01-303 is a Phase 3, open-label, multi-center study to determine the safety and efficacy of NDV-01 in adult participants with NMIBC. The study will include two cohorts: * Cohort 1: a randomized, open-label, parallel group, multi-center, Phase 3 study evaluating the efficacy and safety of the NDV-01 versus observation in participants with histologically confirmed IR-NMIBC. * Cohort 2: an open-label, multi-center, single-arm Phase 3 study evaluating the efficacy and safety of the NDV-01 in two populations of high-risk NMIBC: * Cohort 2a: will include participants with HR-NMIBC who have a biopsy-proven recurrence with CIS ± papillary disease after receiving one or 2 lines of therapy for BCG-unresponsive NMIBC (approved or in development). * Cohort 2b: will include participants with high-risk papillary-only disease (without CIS) NMIBC who have a biopsy-proven recurrence with HG papillary disease after receiving one or 2 lines of therapy for BCG-unresponsive NMIBC (approved or in development). This study will evaluate the safety and efficacy of intravesical administration of NDV-01, and its effect on disease recurrence and progression in patients with NMIBC who have IR disease and have recently undergone a TURBT (Cohort 1) and in patients who have HR BCG-unresponsive disease and who have recurred after first-line therapy for BCG-unresponsive patients - both approved and in development - and are unwilling or unable to undergo radical cystectomy (Cohort 2). Both GEM and DOCE have established safety and efficacy across a range of tumor types, including IR and BCG-unresponsive NMIBC. By combining both GEM and DOCE in an intravesical extended-release formulation, Relmada believes that NDV-01 has the potential to be an agent for second-line therapy in patients who have recurred after first-line therapy in BCG-unresponsive disease, thereby avoiding radical cystectomy. This study will serve as a master protocol for all cohorts included in the study.

Cancer treatment is multidisciplinary and may include radiotherapy. Treatment-related complications represent a burden for patients and the healthcare system. Early recognition of radiotherapy-related side effects is important for timely clinical interventions and improved quality of care. This study aims to improve comprehensive patient management during and after radiotherapy through development and implementation of a web-based application using standardized electronic patient-reported outcome questionnaires (PROMs). Patients will report radiotherapy-related symptoms and quality of life through web-based questionnaires that will be securely transmitted to the Institute of Oncology Ljubljana for review by healthcare professionals. Responses will be categorized using a traffic-light system to guide clinical actions and optimize follow-up visits.

Upper urinary tract invasive cancer magnetic resonance imaging diagnosis

This study is testing a new program to help women who have had pelvic radiation therapy to use vaginal dilators more regularly. Vaginal dilators are important tools that can help prevent or treat vaginal narrowing (called vaginal stenosis), which can happen after radiation and make medical exams or sexual activity painful or difficult. Even though dilators are recommended, many women don't use them as often as needed. In this study, 88 participants will be randomly assigned to one of two groups: * One group will receive the new behavioral program, which includes support and strategies to help with regular dilator use. * The other group will receive written educational materials (enhanced usual care). The study will look at how often and how long participants use their dilators, and whether the program helps reduce symptoms like pain or emotional distress. Participants will complete surveys at the beginning of the study and again at 3, 6, and 9 months, plus short monthly check-ins. The goal is to see if the program is helpful and easy to use, and to prepare for a larger study in the future.

Patients with genitourinary cancers (ex: bladder, testicular, kidney) are at high risk of developing blood clots if they receive systemic therapy (ex: chemotherapy, immunotherapy). Blood clots cause pain, may require hospitalization and invasive testing, and in some cases cause death. In fact, blood clots are one of the leading causes of death in patients with cancer. Furthermore, patients who develop a blood clot require medication to thin the blood for a prolonged (sometimes indefinite) period of time, and this can disrupt other important cancer treatments. Studies have shown that using low dose blood thinners to prevent blood clots during systemic therapy is effective in some patients with cancer. However very few patients in these studies had genitourinary cancers, therefore physicians in Canada are not sure if recommending blood thinners to patients with genitourinary cancers is useful or safe. Safety is a primary concern because blood thinners may cause bleeding, and patients with genitourinary cancers may have higher risk of bleeding than patients with other types of cancer. The investigators hypothesize that blood thinners are effective and safe for reducing blood clots in patients with genitourinary cancers. The objective of this study is to determine if a large clinical trial testing the effectiveness and safety of low dose blood thinners for preventing blood clots in patients with genitourinary cancers receiving systemic therapy is feasible.

PALLSOFT is a randomized, open-label, non-inferiority phase III, multicenter, national trial that will investigate whether the patient-reported symptomatic effect of palliative radiotherapy delivered in 1-2 fractions is non-inferior to palliative radiotherapy delivered in five fractions in patients with pelvic soft tissue tumors from either gastrointestinal, urological or gynecological cancer. Health-related quality of life, toxicities, survival and prognostic and predictive biomarkers will be assessed as secondary and explorative endpoints.

The aim of this study is to describe the tumor microenvironment of solid tumors and to understand the changes induced by anti-cancer treatments, particularly those developed by Innate Pharma. Innate Pharma is a biotechnology company which discovers and develops therapeutic antibodies that exploit the innate immune system to improve cancer treatment. Thanks to this study, it will be possible to correlate clinical and immunological characteristics with the patient\'s clinical features. The analyses generated will contribute to the design and improvement of innovative therapeutic antibodies acting on the immune system

This is the prospective, observational cohort study (Radiogenomics-Urinary), which aims to explore the relationship between the imaging information of urologic cancer patients, tumor microenvironment and the prognosis of urologic cancer patients.

All patients undergoing urological surgery or treatment should receive standardized questionnaires on quality of life, satisfaction, pain and physical recovery. Indication-specific, individual pathways are set up, for example, for patients with localized prostate cancer, benign prostate enlargement, bladder dysfunction or erectile dysfunction. In combination with the clinical data, the PROM data should help to improve the quality of the results and, if necessary, adapt treatment pathways to patient needs.

National Health Service (NHS) England has commissioned The Royal Marsden Hospital NHS Foundation Trust to run a novel mobile clinical outreach service called 'Man Van' with the aim of enabling male patients' easy access to care at the site of their work and in their communities. The initial focus of this new standard of care clinic is to access workplaces with large manual workforces where large scale working from home is not possible. These will include logistics firms and bus companies. These companies employ large numbers of black and minority ethnic men who also have poorer outcomes with a range of other diseases, including Coronavirus disease (COVID)-19. The novel clinical service will collaborate with Unite (and other unions) as well as employers in order to reach our target groups effectively. There is also the opportunity to target higher risk groups e.g. Afro Caribbean communities whose rates of prostate cancer are 1 in 41 as well as occupational higher risk categories. The Man Van has the potential to swing the balance of evidence in favour of Prostate-Specific Antigen (PSA) screening, with a targeted screening program directed at high-risk groups including ethnic minorities and manual workers. Reasons for poorer outcomes amongst these groups are multi-factorial and complex. Levels of education are often a factor which can impact the understanding of the disease and how to seek assistance. Distrust of medical organisations has also been cited as a factor. The aim of the Man Van mobile outreach service is to enable men access to a specific men's health service - focusing on general health and wellbeing (including BMI assessment, blood pressure, blood sugar/diabetes checks etc) and a prostate check for those who raise concerns. This will include a PSA test where relevant. This will be the core data gathered from the project. Patients will receive PSA results in the 'Man Van' by a clinical nurse specialist with patients with raised PSA levels being referred into the standard rapid referral cancer pathways. Similar considerations will apply to men with haematuria detected on dip stick testing or who present with a testicular mass or penile lesion (both rare but important). The clinical data generated from each routine health screening appointment will be analysed to determine the effectiveness of the Man Van mobile outreach model in identifying prostate and other male cancers and other co-morbidities much earlier than if patients had waited to present to their General Practitioner (GP) or other healthcare provider. Patients who receive an early diagnosis of clinically significant prostate cancer will have access to early curative treatments, which are typically less invasive and shorter in timescales. Similar interventions have shown large scale success in particular with breast and cervical cancer. The NHS sees many patients accessing cancer care at a late stage. Reducing this trend is a key objective of the NHS Long Term Plan. The COVID-19 pandemic has further exacerbated health inequalities and mobile clinics can potentially be a model for alleviating this. To enable patients access to medical treatment earlier there is a need to make the 'seeking advice on men's health and prostate issues' less daunting, more normal and easily accessible. The 'Man Van' has the ability to do just that and it is anticipated that the findings of this research, using the data generated from each patient's routine health screening, will demonstrate that a mobile outreach model is more effective in identifying cancers at an earlier stage than 'traditional' diagnostic pathways. We also hope to evaluate the Man Van with a qualitative study looking at the patient perspectives from those who utilise the Man Van. The reasons for high risk in prostate cancer are heavily linked to genetics. This is an issue as there is less recruitment of high risk groups to studies. We hope to gather genetic data from a higher proportion of genetically susceptible men via the Man Van, which can be used in future to further genetic knowledge of prostate cancer.

The project aims to collect fresh biological material derived both from surgical resections performed in diseases, neoplastic and otherwise, of urological relevance at the level of the prostate, bladder, kidney, testicle and genitourinary organs, and from peripheral blood or other fluids biological samples such as urine, seminal fluid, buccal mucosa, feces or saliva, when available.

This research study is a pilot clinical trial, which hypothesizes that the combination of electromagnetic tracking in conjunction with laparoscope imaging and ultrasound probe imaging will aid in reducing the complexity of both laparoscopic lymphadenectomy and/or organ removal in patients with a confirmed diagnosis of cancer in urologic regions of interest (Bladder, Prostate, Testicular, Kidney, Urethral, and Penis), by resulting in better visualization and more accurate localization of certain areas in the diseased organ or the diseased lymph node, and allowing for improved surgical and patient outcomes, fewer complications and better clinician performance.