PIVOTALBoost

• Research type

  Research Study

• Full title

  A phase III randomised controlled trial of prostate and pelvis versus prostate alone radiotherapy with or without prostate boost

• IRAS ID

  219463

• Contact name

  Isabel Syndikus

• Contact email

  Isabel.syndikus@nhs.net

• Sponsor organisation

  The Institute of Cancer Research

• Duration of Study in the UK

  10 years, 0 months, 1 days

• Research summary

  Prostate cancer accounts for 25% of new cancer diagnoses in the UK, and is the most common cancer diagnosis in men. Patients with intermediate and high risk localised prostate cancer are recommended to have either radical prostatectomy or radical radiotherapy combined with hormone therapy. 20-30% of those in higher risk groups are likely to recur following radiotherapy. Intensity modulated radiotherapy(IMRT) and image guidance techniques provide scope for intensifying prostate radiotherapy treatment whilst minimising any associated increase in radiotherapy related side effects. It is, however, currently uncertain whether promising results from planning and cohort studies of these approaches would translate into improved outcomes, without substantial increase in toxicity, in the context of a randomised controlled trial.

  PIVOTALboost aims to determine whether the addition of pelvic node IMRT and/or prostate boost to standard prostate IMRT improves failure-free survival (FFS) compared to standard prostate IMRT alone in patients with high or intermediate risk localised prostate cancer.

  PIVOTALboost is a randomised controlled parallel 4-arm phase III multicentre trial in men with localised high and intermediate risk prostate cancer. Consenting patients will be randomised to receive either:
  A) Prostate IMRT (control)
  B) Prostate and pelvic IMRT
  C) Prostate IMRT and prostate boost
  D) Prostate and pelvic IMRT and prostate boost

  All radiotherapy will be delivered using image guidance. Prostate boost will be delivered to the whole gland using High-Dose Rate Brachytherapy (HDRB), or to focal disease using focal HDRB or focal Intensity Modulated Radiotherapy (IMRT).

  Patients will be followed up for disease outcome, acute and late toxicity and quality of life; health economic details will also be captured. The study will recruit 1952 patients.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  17/LO/0731

• Date of REC Opinion

  19 May 2017

• REC opinion

  Favourable Opinion