BladderPath Trial Information
||Professor Nicholas James
||University of Birmingham
||NIHR Health Technology Assessment (HTA)
Randomised Phase II/III Clinical Study of a Non-Investigational Medicinal Product
|UKCRN Study ID: (if applicable)
|ISRCTN Referance Number:
|Open to new sites?
|Recruitment start date:
|| 31st May 2018
|Anticipated Recruitment end date
||30th June 2021
|CRCTU Study Management Team:
||Late Phase Trial Management Team A
|Study E-mail Address:
Bladder cancer treatment and outcomes have not changed significantly in 30 years. Standard management comprises local anaesthetic inspection of the bladder with a small endoscope. If a bladder tumour is seen, the patient then proceeds to general anaesthetic removal of the tumour via a larger, rigid cystoscope - transurethral resection of bladder tumour (TURBT).
A major concern with the current pathway is that TURBT delays the definitive treatment - in the UK the typical delay from presentation to treatment is over 100 days. We believe that the prolonged pathway and potentially unnecessary TURBT may contribute to the poor outcomes seen with bladder cancer – around 50% will die of the disease within 5 years.
We propose to test a modified pathway in which we would use flexible cystoscopy plus biopsy as initial assessment. The very small biopsy obtainable by this procedure is sufficient to confirm the presence of cancer and also the grade of tumour (high or low). Most muscle-invasive bladder cancer (MIBC) tumours are high grade. Non-muscle invasive bladder cancer (NMIBC) tumours may be high or low grade. The urologist can also assess the overall appearance of the tumour. Combining these factors, we can partition patients into probable NMIBC (low grade tumour, sea anemone-like appearance) and possible MIBC (high grade tumour, solid appearance). Probable NMIBC (around 50% of the total) would continue with current standard therapy. Those with possible muscle-invasion would proceed to MRI scan and be further separated into MIBC and NMIBC. Patients with no evidence of muscle-invasion would proceed to standard TURBT. Patients with evidence of muscle-invasion will proceed directly to definitive therapy, avoiding TURBT and reducing delay. Patients entering the study would be randomly assigned to either the current standard pathway 1 or the image-directed pathway 2.
Please note that the study team cannot give individual’s clinical advice. Patients and their families should contact their treating physician to discuss trials for which they may be eligible.
Clinical study protocols are complex technical documents which should only be used for the treatment of subjects taking part in the study. Patients who are interested in taking part in the study are advised to talk to their health care professional or refer to the CancerHelp website, see link below.
Investigators please ensure you have R&D approval for this specific version of the protocol before using as a reference.