Active clinical trials for "Urinary Bladder Neoplasms"

A national, multicenter, non-randomized, retrospective, observational study (Real-World Evidence-RWE) aimed at analyzing clinical presentation profiles and demographic characteristics of patients with early urothelial bladder cancer (high-risk non-muscle invasive and localized muscle-invasive) treated with standard therapies in national cancer treatment reference centers within the last 6 years (between 2017 and 2022).

Background: In European Association of Urology (EAU) Guidelines, the vast majority of non-muscle-invasive bladder cancers (NMIBCs) undergo a primary transurethral resection of the bladder tumor (TURBT) followed by a repeat TURBT (Re-TURBT). The Re-TURBT is recommended due to the possibility of residual bladder cancer but is unnecessary in many cases by constituting overtreatment. Currently, no diagnostic strategy or predictive tools have been implemented to further stratify who does or does not benefit from Re-TURBT. Recently, an MRI-based Vesical Imaging Reporting and Data System (VI-RADS) score has been developed to stage as to the preoperative probability of muscle invasion, which could potentially exclude those who do not require a Re-TURBT when a primary high-quality resection is delivered. As such, performing TURBT with standard white light (WL) cystoscopy is known to miss many bladder tumours, which may be poorly visible, and a technique known as with photodynamic diagnosis (PDD) results in lower residual tumor and lower early intravesical recurrence rates. PDD is performed using violet light to improve the detection of these lesions not easily visible with WL cystoscopy. Methods/Aims: The investigators propose an Italian, single-center, phase IV, open-label, non-inferiority, randomized controlled trial, in which participants (n=112) who had already received a mpMRI/VI-RADS score, are randomized to receive PDD-TURBT, no Re-TURBT versus standard of care represented by conventional WL-TURBT followed by WL-Re-TURBT. The primary outcome is proportions of early recurrence in the urinary bladder. Secondary outcomes will include proportions of late BCa recurrence, late disease-free interval, time to progression to MIBC, patient's quality of life assessment, and cost-analysis. Perspective: The CUT-less trial aims to respond to this unmet need through a non-inferiority randomized clinical study potentially shaping the perspective for a paradigm shift towards a more personalized, socially, and economically sustainable updated NMIBC therapeutic pathway. Implications: The current clinical trial proposal is aiming to achieve a paradigm shift in the oncological and socio-economical management of urothelial malignancies of the urinary bladder. Our first concern is indeed to guarantee a safe and ground-breaking strategy to manage the pathway of such patients in order to guarantee the non-inferior oncologic safety (and possibly superiority) when compared to the current standard of care. Additionally, if our hypotheses are confirmed, the investigators will be able to significantly relieve these patients from the oncologic burden of an already invasive and arduous bladder cancer care path. Finally, safely avoiding an unnecessary, expensive surgical procedure will bring significant social and economic benefits to the EU healthcare system and possibly worldwide.

Bladder cancer is often treated with cystectomy or radiation therapy. Following radiation therapy patients will often have severe side effects from the treatment. Studies have suggested that simultanously treatment with androgen deprivation therapy during radiation therapy may be able to proctect stemcells in the bladder, thus improving tissue recovering post-radiation, which would result in improved bladder compliance following the treatment and ultimately result in fewer side effects and overall improved patient quality of life.

Bladder cancer is the most common urinary tract cancer and the 5th most common cancer in the US (1). Yet bladder cancer research is underfunded relative to other common cancers. As a result, bladder cancer care is prone to evidence gaps that produce decision uncertainty for both patients and clinicians. The Comparison of Intravesical Therapy and Surgery as Treatment Options (CISTO) for Bladder Cancer Study has the potential to fill these critical evidence gaps, change care pathways for the management of NMIBC (non-muscle-invasive bladder cancer), and provide for personalized, patient-centered care. The purpose of CISTO is to conduct a large prospective study that directly compares the impact of medical management versus bladder removal in recurrent high-grade NMIBC patients with BCG (Bacillus Calmette-Guerin) failure on clinical outcomes and patient and caregiver experience using standardized patient-reported outcomes (PROs).

This study evaluates the general physical, emotional, and sexual function in women undergoing a radical cystectomy for bladder cancer. A radical cystectomy is a surgical procedure that involves the removal of the bladder, uterus, ovaries, fallopian tubes, and part of the vagina. This may affect sexual function in women. This study seeks to understand how radical cystectomy alters sexual function and well-being, and what factors may affect this change.

PEBBLE is an open-label, international, multicentre, window of opportunity phase II trial that aims to evaluate the effects of short-term preoperative therapy with bintrafusp alfa in patients with histologically confirmed urothelial carcinoma requiring radical surgery with bilateral pelvic lymph node dissection. Eligible patients will receive 4 doses of bintrafusp alfa (1200mg flat dose) at 14 day intervals before undergoing radical surgery. Patients will attend study visits at 6, 12 and 24 weeks following their surgery. After the 24-week post-surgical visit, patients will enter a follow up phase during which they will be contacted annually for 2 years after their surgery to collect survival and disease status data. The efficacy of bintrafusp alfa will be assessed on CT/MRI scan images and tumour tissue samples collected at baseline and after treatment with bintrafusp alfa.

Superficial bladder cancer, known as non-muscle-invasive bladder cancer (NMIBC), is the most common type of bladder cancer. It is expensive to manage and significantly impacts on patients' quality of life. This is because there is a high burden of recurrent disease after initial treatment, and need for long term surveillance for recurrence. The most important step in the diagnosis and treatment of NMIBC is the first surgical procedure called the transurethral resection of bladder tumour (TURBT). There is evidence that the quality of the TURBT operation, and the use of a single administration of bladder chemotherapy following the operation, can reduce cancer recurrence rates and progression to more invasive cancer. There is anecdotal evidence that the quality of TURBT surgery and the usage of intravesical chemotherapy varies widely between hospitals and thus may result in worse outcomes for some patients. The primary objective of the study is to determine if audit and feedback can improve the quality of TURBT surgery and if this reduces recurrence of NMIBC.

A study to compare Hexvix Blue light cstoscopy with standard White light cystoscopy in the detection of bladder cancer.

For patients with high-risk non-muscle-invasive bladder cancer (NMIBC), intravesical therapy of BCG is the standard treatment proved to reduce the risk of recurrence and progression. However, there are patients failed to complete the whole treatment due to the long period and some patients showed no response to BCG or suffered tumor progression after BCG treatment. The aim of this study is to examine the efficacy and safety of intravesical therapy of BCG combined with PD-1 monoclonal antibody as the treatment of high-risk NMIBC patients without BCG treatment. At the same time, transcriptome sequencing is used to analyze the correlation between the efficacy of the treatment and the level of immune cell infiltration and tumor molecular subtypes.

Aim: To investigate the feasibility and tolerability of the Olympus Soltive laser in treatment of large recurrent low-grade Ta tumours in an outpatient setting. Background: Non-muscle invasive bladder cancer (NMIBC) is associated with a high yearly recurrence rate up to to 61%. Patients affected are therefore referred to long-term or even life-long follow-up, which burdens both patients and health care system. Recurrent tumours are most frequently treated with TURBT followed by adjuvant intravesical treatment. Repeat TURBT includes a risk of morbidity from the procedure itself and from general anaesthetics, which the procedure requires. Patients with NMIBC are generally elderly, multi-morbid, and as a result, they often show a poor tolerability of general anaesthetics. Thus, the need for non-surgical treatment modalities is imminent and continuous investigations are performed in the field including active surveillance, chemoresection and device-assisted intravesical chemotherapy. Laser ablation is a technique gaining attention in the treatment of NMIBC, based on the prospects of an outpatient treatment modality, which could prove TURBT and general anaesthesia unnecessary in select patients. Methods: The study will be conducted as a prospective feasibility study. Included patients will undergo outpatient laser ablation using the Olympus Soltive laser under local anaesthetics. Patients will be included from Aarhus University Hospital (Denmark), Fundació Puigvert (Spain), Motol University Hospital (Czech Republic) and Institut Universitaire du Cancer Toulouse Oncopole (France). Data will be reported to the eCRF in the online REDCap web application. The eCRF is stored on a secure server under the responsibility of the Department of Clinical medicine at Aarhus University in Denmark. REDCap is a secure web application for building and managing online surveys and databases. The Database will be in agreement with the laws and regulations of the Danish Data Protection Agency and EU regulations (GDPR). The sponsor will be overall responsible for the data entry in the eCRF, and the validity of the data collected at the specific sites. Each participant will be coded with a unique patient identifier to ensure pseudo anonymity. Perspectives: This study will be the first multinational study with focus on feasibility of outpatient laser ablation of large bladder tumours between 1-3 cm. Outpatient laser ablation of these large tumours has the potential to reduce the number of TURBTs per patient, thus easing the life of patients with non-muscle invasive bladder cancer, with fewer surgical procedures as well as reducing the overall treatment related costs for society. If thulium laser ablation proves effective, the treatment modality would be easily implemented and available based on the small size of the machinery.