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Trials Update

Trials Update. Connie Shiridzinomwa Urology Research Nurse. Recruiting trials. Add-Asprin IROC Pre-Empt PRIM. Recruiting Trials. Add-aspirin

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Trials Update

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  1. Trials Update Connie ShiridzinomwaUrology Research Nurse

  2. Recruiting trials • Add-Asprin • IROC • Pre-Empt • PRIM

  3. Recruiting Trials • Add-aspirin A phase III, double-blind, placebo-controlled, randomised trial assessing the effects of aspirin on disease recurrence and survival after primary therapy in common non-metastatic solid tumours. • Recruiting areas, gastro, prostate and colorectal • Target 30 end of recruitment January 2021 • Recruited 24 • Recruitment challenges: Uptake decrease following media

  4. Recruiting trials • IROC • A phase III multicentre randomised controlled trial to compare the efficacy of Robotically Assisted Radical Cystectomy (RARC) and intracorporeal urinary diversion with Open Radical Cystectomy (ORC) in patients with bladder cancer • Trust target 15 end of recruitment Nov 2018 • Recruited 12 • Challenges: Large catchment area network patients not prepared to come back for follow-up visits.

  5. Recruiting Trials • Pre-EMPT: The Prostate cancer – Exercise and Metformin Trial (Pre-EMpT) is organised by the National Institute for Health Biomedical Research Centre (Nutrition), which is funded by the National Institute for Health Research and is a partnership between the University Hospitals Bristol NHS Foundation Trust and the University of Bristol. • Target 183, end date March 2020 • Recruited 6, all in surgery • Recruitment challenges: Slow up take, people already on Metformin, difficult pathway for radiotherapy and AS

  6. Recruiting trials • PRIM: Prostate Health Index (PHI)- to Refine prostate Imaging by MRI (PRIM): • Target 100, end of recruitment August 2019 • Recruited from 28 • No challenges at present

  7. Trials in follow-up • POUT (close date Dec 2021) • Boxit (close date Dec 2018) • Radicals (close date 2031) • Source (follow-up until progression) • MASTER (closing date Dec 2019)

  8. Studies in set-up • JANSSEN: Randomized, Double-blind, Placebo-controlled, Phase 3 Study of Apalutamide in Subjects with High-risk, Localized or Locally Advanced Prostate Cancer Who are Candidates for Radical Prostatectomy • HAARP:(Newcastle) Home Assessment of urinary voiding and storage function before and After Radical Prostatectomy for prostate cancer: setting patient expectations (The HAARP study) • Neurosafe : (UCL)  A single blinded, multi‐centre, feasibility study to evaluate the ability to randomise men with prostate cancer into a trial comparing NeuroSAFE Robotic assisted radical prostatectomy (RALP) to standard Robotic assisted radical prostatectomy(RALP).

  9. Studies in set up • CamProbe: ( Cambridge)Developing a safer and simple device for local anaesthetic transperineal prostate biopsies • Gap 4  Interval: (Movember)difficulties in setting this study up include delivery of the exercise intervention, work is ongoing to try to resolve this.

  10. Thank you for your patience.

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