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A randomised phase II trial of Prostate and pelvIc Versus prOstaTe ALone radiotherapy treatment volumes using high dose IMRT for locally advanced prostate cancer.

Disease site: Urological  Prostate cancer

Treatment modality: Radiotherapy

Status: In active follow-up

Trial details

PIVOTAL is a phase II trial randomising between prostate and prostate + pelvic Intensity Modulated Radiotherapy (IMRT) in patients with locally advanced prostate cancer.  

The primary objective is to evaluate the acute side effects of prostate + pelvic IMRT in a multi-centre setting.  Should the level of side effects fall within a predefined acceptable range, the intention is to progress to a phase III trial investigating treatment efficacy.

Chief Investigator: Professor David Dearnaley, The Royal Marsden NHS Foundation Trust

ICR-CTSU Scientific Lead: Dr Emma Hall

Trial management contact: Rebecca Lewis - Senior Trial Manager, [email protected]

ISRCTN: 48709247

Sponsor: The Institute of Cancer Research

Funding: Cancer Research UK (CRUK/10/022)

Lay summary

Results of the PIVOTAL trial – lay summary

Publications and presentations

Dearnaley D, Griffin CL, Lewis R, Mayles P, Mayles H, Naismith OF, Harris V, Scrase CD, Staffurth J, Syndikus I, Zarkar A, Ford DR, Rimmer YL, Horan G, Khoo V, Frew J, Venkitaraman R, Hall E. Toxicity and Patient-Reported Outcomes of a Phase 2 Randomized Trial of Prostate and Pelvic Lymph Node Versus Prostate only Radiotherapy in Advanced Localised Prostate Cancer (PIVOTAL). International Journal of Radiation Oncology • Biology • Physics.

Victoria A. Harris, John Staffurth, Olivia Naismith, Alikhan Esmail, Sarah Gulliford, Vincent Khoo, Rebecca Lewis, John Littler, Helen McNair, Azmat Sadoyze, Christopher Scrase, Aslam Sohaib, Isabel Syndikus, Anjali Zarkar, Emma Hall, David Dearnaley, Consensus Guidelines and Contouring Atlas for Pelvic Node Delineation in Prostate and Pelvic Node Intensity Modulated Radiation Therapy, International Journal of Radiation Oncology*Biology*Physics, Volume 92, Issue 4, 2015, Pages 874-883,

Clinical trials

Division of Clinical Studies

The division carries out or coordinates high-quality trials and translational research at both an early phase – typically to test new targeted drugs – and a later stage.