Clinical trial participation
The BURST Research Collaborative would like to encourage its Urological Registrar members to actively participate in ongoing national clinical trials. BURST is working in collaboration with the Clinical Trials and Statistics Unit at the Institute of Cancer Research (ICR-CTSU) in order to further the research opportunities for BURST members.
We would like to highlight some surgical urology trials that are relevant to our members and would encourage you to assist with patient identification in your current role.
For trainees working at a unit where the trial is open already but you would like to get involved in recruiting patients:
Please discuss this with the principal investigator (PI) at your site to let them know that you are interested in recruiting patients for the study – they will usually be delighted that you have shown an interest. If you will be involved in approaching patients you will need to have Good Clinical Practice (GCP) training (half day online course), need to view the trial site initiation materials and be included on the trial delegation logs. Please contact the trial team using the details below if you need any advice on how to get involved.. If you are able to commit a lot of time to the success of the study at your site, you may ask your PI if he is willing to make you a Co-PI.
For trainees working at a unit where a trial is not open but you would like to participate:
If you are interested in supporting the setup and recruitment to one of these trials and be Co-PI on a study at your site, please discuss the trial with the most relevant Consultant Urologist/Clinician at your unit. They would need to act as who agrees to be Principal Investigator and agree to oversee study conduct at your Trust. Please contact the trial team using the details below if you need any advice on how to get involved or once you have identified a potential PI at your site to progress with site setup.
Information about where each trial is currently running and start and end dates can be found on the UK Clinical Trial Gateway: https://www.ukctg.nihr.ac.uk/home/
CALIBER (Non-muscle invasive bladder cancer)
CALIBER is randomised, multicentre, phase II feasibility study investigating whether intravesical MMC (chemoresection) could be a treatment option for people with recurrent low risk, non-muscle-invasive bladder cancer. Patients will either receive four once-weekly intravesical instillations of 40mg mitomycin C or standard surgical management in use at their hospital for treatment of recurrence. The trial objective is to demonstrate that chemoresection has sufficient activity against NMIBC to warrant further investigation of its role as a potential alternative to surgical intervention for low risk NMIBC recurrence.
Trial opened January 2015, planned recruitment period 2-3 years.
PHOTO (Non-muscle invasive bladder cancer)
PHOTO is a pragmatic, multicentre, randomised controlled phase III trial, investigating the efficacy of using photo-dynamic diagnosis (PDD) under blue light – instead of white light – for transurethral resection of bladder tumour (TURBT) in intermediate and high risk non-muscle invasive bladder cancer. PHOTO has two main objectives (1) Clinical effectiveness: compare time to recurrence, for each of the two treatment strategies, with a principal point of interest at 3 years. (2) Cost-effectiveness: evaluate cost-effectiveness by the incremental cost for recurrence avoided and cost-utility as the incremental cost per quality-adjusted life year (QALY) gained at three years.
Trial opened October 2014, planned recruitment period 3 years.
POUT (upper tract urothelial carcinoma)
POUT is a phase III, multicentre, randomised controlled trial to determine the efficacy, safety and effects on patients’ quality of life of adjuvant chemotherapy following radical nephro-ureterectomy for invasive upper tract urothelial carcinoma. POUT aims to determine whether adjuvant combination chemotherapy improves the disease-free survival for patients with resected histologically confirmed muscle invasive (pT2-T4, N0-3) or node positive upper tract urothelial carcinoma. Participants will either receive immediate platinum based combination chemotherapy (gemcitabine–cisplatin or gemcitabine–carboplatin) or be allocated to the surveillance group to be closely monitored for signs of recurrence, receiving appropriate treatment if disease returns.
Trial opened May 2012, planned recruitment period 7 years.
InPACT (penile carcinoma)
InPACT is an international phase III trial with a Bayesian design incorporating two sequential randomisations (InPACT-neoadjuvant and InPACT-pelvis) in patients with squamous carcinoma of the penis who have inguinal lymph node metastases (i.e. locally advanced disease). InPACT aims to determine: If there is a role for neoadjuvant therapy in this patient group; and If prophylactic pelvic lymph node dissection (PLND) improves survival in patients at high risk of recurrence following inguinal lymph node dissection (ILND).
Trial opened: March 2017, planned recruitment period 5 years.
PACE (localised prostate cancer)
PACE is a multicentre, international phase 3 randomised controlled study to assess whether hypofractionated stereotactic body radiotherapy (SBRT) offers therapeutic benefit over prostatectomy (PACE-A) or conventional radiotherapy (PACE-B) in men with early stage, organ-confined prostate cancer.
Trial opened: August 2012, planned recruitment period 8 years.