Please enable JavaScript or talk to your local administrator to get JavaScript enabled.

Project

BladderPath: Image Directed Redesign of Bladder Cancer Treatment Pathways

Funder: NIHR Evaluation Trials and Studies Coordinating Centre

Funding period
GBP 1.5 M
USD 2.0 M
Funding amount
Abstract
Bladder cancer outcomes and treatment pathways have not changed significantly in 30 years. Following initial assessment in a haematuria clinic standard management involves initial rigid cystoscopic transurethral resection of bladder tumour (TURBT) followed by further treatment for muscle invasive disease (MIBC) such as cystectomy or chemo-radiotherapy. TURBT has the dual purpose of staging and for non-muscle invasive disease (NMIBC) removal of the tumour. For MIBC TURBT is frequently sub-optimal for staging delays definitive appropriate therapy and may contribute to dissemination of the tumour either extravesically by bladder perforation or systemically by increasing circulating tumour cells. Additionally post-TURBT cross-sectional pelvic imaging is hard to interpret due to post-procedure artefacts such as perivesical inflammation or reactive lymph nodes interpreted as nodal spread. Delay in treatment may adversely affect prognosis. The ideal pathway would therefore separate NMIBC patients from MIBC patients early in the pathway.We are testing a modified pathway in which we use a combination of i) tumour appearance ii) histology and iii) initial radiology to stratify care. Each of these parameters can independently discriminate MIBC from NMIBC. By combining these three factors we can partition patients into probable NMIBC (low-grade tumour papillary/narrow stalk appearance) and possible MIBC (high grade tumour solid appearance CT suggestive of invasion). Those with proven histological high-grade or probable clinical/radiological muscle invasion (up to 50%) will proceed to multi-parametric MRI (mpMRI) which has a high sensitivity and specificity for distinguishing NMIBC from MIBC. Patients with no evidence of MIBC will proceed to standard endoscopic resection. Patients with probable MIBC will proceed to definitive therapy (chemotherapy surgery or radiotherapy according to patient characteristics). These patients will have avoided a TURBT had imaging unaffected by prior surgical procedures and a shorter pathway to definitive therapy. In addition subsequent MRI scanning could more accurately assess patients’ responses to chemotherapy and radiotherapy.The trial is randomised at presentation. The randomisation is standard pathway 1 versus image-directed pathway 2. The trial has 3 stages: feasibility; intermediate and definitive stage.Feasibility StageDuration: 1 year in 3 centres (total c. 150 patients assuming 33% recruitment).Endpoints:•Feasibility of pathway 2•Proportions of possible MIBC patients randomised to pathway 2 who undergo mpMRI as per protocol Intermediate StageAim: To assess time to MIBC-appropriate definitive treatment (TTDT). Our target is a minimum reduction of 30 days on pathway 2 for MIBC patients measured from 1st informed consent to 1st definitive treatment.Endpoints:•for MIBC: time to first of chemotherapy radiotherapy or surgeryDefinitive StageAssuming feasibility an acceptably small rate of protocol violation and a reduction in TTDT on pathway 2 for MIBC we will continue recruitment to the trial with the following endpoints:•Primary outcome: time to disease progression (loco-regional or metastatic)•Secondary outcomes: overall and disease-specific survival health economics TTDT for NMIBC
Similar projects All >
Sorted by: Start Date
Project list item
Epigenetic regulators of subtype plasticity in bladder cancer

Bladder Cancer Advocacy Network to John Robert Christin

USD 1,700
2020 - 2020
Project list item
Implication of neutrophil extracellular traps in the efficacy of bladder-sparing therapy in muscle invasive bladder cancer

Canadian Institutes of Health Research to Wassim Kassouf, Jonathan David Spicer, Ciriaco A. Piccirillo

USD 138,878
2020 - 2025
Project list item
CD40 agonism for the treatment of bladder cancer

National Cancer Institute to CHRISTOPHER STUART GARRIS

USD 64,554
2020 - 2023
Project list item
Engineering Smart Solutions for Disorders of the Bladder Urothelium

Engineering and Physical Sciences Research Council

 
2019 - 2023
Project list item
Targeting FGF in Bladder cancer after Neoadjuvant Immunotherapy and Surgery

American Association For Cancer Research to Joshua James Meeks

USD 25,000
2019 - 2020

System

Categories
  • FOR (ANZSRC)

    1103 Clinical Sciences

  • FOR (ANZSRC)

    1112 Oncology and Carcinogenesis

  • RCDC

    Cancer

  • RCDC

    Clinical Research

  • RCDC

    Clinical Trials and Supportive Activities

  • RCDC

    Urologic Diseases

  • HRCS HC

    Cancer

  • HRCS RAC

    4.2 Evaluation of markers and technologies

  • HRCS RAC

    6.4 Surgery

  • Health Research Areas

    Clinical

  • Broad Research Areas

    Clinical Medicine and Science