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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Ms Heather Poad
+44 113 343 4033
ctru-bravo@leeds.ac.uk


Prof James Catto
+44 114 271 2295
j.catto@sheffield.ac.uk


Study Location:

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Be Part of Research - Trial Details - BRAVO Study: Surgery vs. Immunotherapy – Which treatment is best in bladder cancer?
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BRAVO Study: Surgery vs. Immunotherapy – Which treatment is best in bladder cancer?

Not Recruiting

Open to: All Genders

Age: Adult

Newcastle upon Tyne Sheffield Harrogate Barnsley Scunthorpe Bradford Doncaster Wakefield HALIFAX Leeds Hull Keighley Huddersfield Chesterfield Whitehaven Carlisle Rotherham

Medical Conditions

Specialty: Cancer, Primary sub-specialty: Bladder
UKCRC code/ Disease: Cancer/ Malignant neoplasms of urinary tract

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Oct 2016 31 Mar 2018

Publications

2017 Protocol article in https://pubmed.ncbi.nlm.nih.gov/28801444/ protocol (added 27/11/2020)2021 Results article in https://pubmed.ncbi.nlm.nih.gov/33332191/ results (added 17/08/2021)2024 Other publications in https://pubmed.ncbi.nlm.nih.gov/39324506/ (added 27/09/2024)

Interventional

Intervention Type : Procedure/Surgery
Intervention Description : Participants will be randomised on a 1:1 basis to receive either RC or mBCG. A computer-generated adaptive minimisation algorithm that incorporates a random element will be used to ensure the treatment groups are well balanced for the following characteristics:1. Age (<75, >=75)2. Sex (male, female)3. Cancer centre (Sheffield, Leeds, Bradford, Wakefield, Hull, Newcastle)4. Tumour stage (pTa/pTis, pT1)5. Presence of CIS (Yes, No)6. Previous low risk bladder cancer (Yes, No)

mBCG group: Within this study, a maintenance BCG regimen is to be used. The regimen requires that at least 12 months of BCG treatment is given (starting with and including the initial dose). Treatment beyond one year is as per standard care.Induction BCG:Maintenance treatment should start within 2-4 weeks of randomisation (administration once a week for six weeks). Delays and deferrals due to complications or toxicity are common and allowed within this study. BCG induction should include at least 4 doses of BCG. The induction treatment should be completed within 10 weeks from the date of the first dose.First check cystoscopy:Following induction BCG, a check cystoscopy should be performed after a 6-week break. Within this study, the first cystoscopy should be performed using a rigid cystoscope and should include the obtainment of bladder washings or voided urinary cytology, and at least one biopsy of the bladder urothelium (either the tumour scar and/or red areas within the bladder). Fluorescence or narrow band imaging may be used, as per local hospital protocols. Histological review of the bladder biopsies and urinary cells should be performed to determine the presence or absence of BC. In the absence of carcinoma or in the presence of high risk (high grade or grade 3) non-muscle invasive bladder cancer (HRNIMBC) then the patient may continue with mBCG. The presence of an invasive BC requires the cessation of mBCG and a clinical consultation to discuss radical treatment or other treatment options.First BCG maintenance:Following cystoscopy, and after a wait of two weeks (and the cessation of haematuria), then three weeks of intravesical BCG is administered according to hospital practice. Unlike subsequent BCG cycles these first doses of BCG maintenance should take place in the presence of HRNIMBC. After an eight week break from the last BCG dose either a flexible or rigid cystoscopy should be carried out. Urinary cells (either voided cytology or bladder washings) should be obtained. A biopsy of the bladder lining is not mandated after the first rigid cystoscopy.Subsequent BCG maintenance:As per the first BCG maintenance doses with the exception that if high risk NMIBC is detected mBCG should be discontinued and a clinical consultation should take place to discuss radical treatment or other treatment options.mBCG and surveillance within this feasibility study ceases after one year post randomisation, or three months after the last patient is randomised. The patient should continue with their care according to standard hospital practice and applicable guidelines.Follow up data will be collected for each cycle of treatment at the cystoscopy visits

Radical Cystectomy: Surgery can be performed by either an open, laparoscopic or robotic route as per usual practice within that unit and as per accreditation. Minimally invasive or open surgery are acceptable, however surgeons should avoid undertaking surgery within this study whilst on their learning curve for a modality. In this study surgery should take place within 8 weeks of randomisation.Radical cystectomy should include removal of adjacent organs. In males, this includes the prostate and seminal vesicles. In females, this should include a section of adjacent anterior vaginal wall, the uterus, cervix and fallopian tubes and, if no bladder reconstruction is planned, the urethra. Oophorectomy is optional, as per local practice and individualised for each patient. Exceptions to this surgical plan are acceptable with prior approval from CTRU. Within this study, pelvic lymphadenectomy is mandated. The template for lymphadenectomy should include, at least, the regional lymph nodes up to the level of the ureteric crossing of the common iliac vessels. This includes the obturator fossa, the external iliac and internal iliac nodes. A more extended lymphadenectomy is acceptable. Excised lymphatic tissue should be submitted for histological analysis. Reconstruction through all routes is acceptable. It is anticipated this will mostly include ileal conduit and orthotopic neobladder. As for surgeon accreditation, the pattern of reconstruction should mirror the cases within the submitted RC cases. Perioperative care is to be carried out as per ERAS protocols and standard practice. Post-operative care is to be carried out as per standard practice. Follow up frequency will be in line with current NHS practice, with data collected at routine follow up visits at 3, 6 and 12 months post randomisation +/- 2 weeks. An intravenous urogram (IVU) is carried out at approximately 2-4 weeks post RC and should be carried out per standard care.

For both study arms, follow up imaging by CT scan will be performed as per local practice and for the study should be arranged at one year post randomisation (+/-2 weeks). Wherever possible the one year post randomisation CT scan should be in the above time window to allow comparison between the two trial arms. Participants will be asked to complete questionnaires at baseline, 3 months, 6 months and at 12 months post-randomisation or until the end of the study follow-up period (one year post randomisation or three months after the last participant has been randomised if earlier).




You can take part if:



You may not be able to take part if:


1. Solely non-urothelial or variant urothelial pathology 2. Unable or not willing to give informed consent 3. Previous high risk (high grade or grade 3) NMI or invasive bladder cancer 4. Any previous treatment with intravesical BCG 5. Any other malignancy (excluding non-melanomatous skin cancer, low-risk prostate cancer and prior low risk bladder cancer)


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Freeman Hospital
    Freeman Road High Heaton
    Newcastle upon Tyne
    NE7 7DN
  • Royal Hallamshire Hospital
    Glossop Road
    Sheffield
    S10 2JF
  • Harrogate District Hospital
    Lancaster Park Road
    Harrogate
    HG2 7SX
  • Barnsley Hospital NHS Foundation Trust
    Gawber Road
    Barnsley
    S75 2EP
  • Scunthorpe General Hospital
    Cliff Gardens
    Scunthorpe
    DN15 7BH
  • Bradford Royal Infirmary
    Duckworth Lane
    Bradford
    BD9 6RJ
  • Doncaster Royal Infirmary
    Armthorpe Road
    Doncaster
    DN2 5LT
  • Pinderfields Hospital
    Aberford Road
    Wakefield
    WF1 4DG
  • Calderdale Royal Hospital
    Salterhebble
    HALIFAX
    HX3 0PW
  • St James’ University Hospital
    Beckett Street
    Leeds
    LS9 7TF
  • Castle Hill Hospital
    Castle Road Cottingham
    Hull
    HU16 5JQ
  • Airedale General Hospital
    Skipton Road
    Keighley
    BD20 6TD
  • Huddersfield Royal Infirmary
    Acre Street
    Huddersfield
    HD3 3EA
  • Chesterfield Royal Hospital
    Chesterfield Road Callow
    Chesterfield
    S44 5BL
  • West Cumberland Hospital
    Homewood Road
    Whitehaven
    CA28 8JH
  • Cumberland Infirmary
    Newton Road
    Carlisle
    CA2 7LT
  • Rotherham Hospital
    Moorgate Road
    Rotherham
    S60 2UD

This information has not yet been provided by the study team. You'll have an opportunity to discuss any risks and benefits that may be associated with this study prior to consenting to taking part.

Prof James Catto
+44 114 271 2295
j.catto@sheffield.ac.uk


Ms Heather Poad
+44 113 343 4033
ctru-bravo@leeds.ac.uk



The study is sponsored by Sheffield Teaching Hospitals NHS Foundation Trust and funded by Yorkshire Cancer Research.



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Read full details for Trial ID: ISRCTN12509361
Last updated 27 September 2024

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