Who is included in the study? 

PIVOTALboost includes 2,229 people with prostate cancer that has a medium or high risk of returning after treatment and has not spread elsewhere in the body. Everyone joining the study will start hormone therapy before receiving radiotherapy. Participants are enrolled at NHS hospitals across the UK. 

What are the study treatments? 

Everyone who joins the trial will be in one of four treatment groups:

• Prostate radiotherapy (standard treatment)
• Prostate and pelvis radiotherapy (enrolment to this group closed in 2022)
• Prostate radiotherapy with boost to the cancer within the prostate or the whole prostate gland
• Prostate and pelvis radiotherapy with boost to the cancer within the prostate or the whole prostate gland

Radiotherapy will be given every week day for four weeks. 

People in the boost groups will have their boost given either: 

• With a temporary implant put into the prostate before or after radiotherapy
• With radiotherapy at the same time as the rest of their treatment

Participants have regular check ups during and after their treatment and we collect information about how they are getting on until the study is completed.

Contact details and regulatory information 

Chief Investigator: Professor Isabel Syndikus, Clatterbridge Cancer Centre

ICR-CTSU scientific lead: Professor Emma Hall

Trial management contact: [email protected]

Sponsor: The Institute of Cancer Research

Funding: Cancer Research UK

Trial identifiers 

REC reference: 17/LO/0731

CPMS ID: 34511

ISRCTN: ISRCTN80146950

Publications and presentations 

Review of data quality following a transition to telephone follow up in phase III multicentre clinical trials as a result of the COVID-19 pandemic. V. Hinder, L. Philipps, M. Mahmud, A. Omar, S.Brown, C.Cruickshank, S. Burnett, I. Syndikus, N. Van As, A. Tree, E. Hall (NCRI Oct 2021)

PIVOTALboost:  A phase  III  randomised controlled trial of prostate and pelvis versus prostate alone radiotherapy with or without prostate boost (CRUK/16/018). Syndikus I, Cruickshank C, Staffurth J, Tree A, Henry A, Naismith O, Mayles H, Snelson N, Hassan S, Brown S, Porta N, Griffin C, Hall E. Clinical & Translational Radiation Oncology (2020)

Successful Implementation of Treatment Planning Trial QA for PIVOTALboost Trial.  Mayles H, Naismith O, Snelson N, Syndikus I, on behalf of PIVOTALboost TMG. Radiotherapy and Oncology (2020) 152

PIVOTALboost Trial Contouring RTQA.  Syndikus I, Tree A, Staffurth J, Mayles H, Naismith O, Snelson N, Montazeri A, Hall E.  Abstract submitted to ASCO 2020 Genitourinary Cancers Symposium. Journal of Clinical Oncology 38, no. 6_suppl (February 20, 2020) 373-373.February 13-15, 2020).  

Updating recruitment forecasts via simulations to explore impact of availability of experimental arms in the phase III PIVOTALboost trial.  Porta N, Hinder V, Griffin C, Tree A, Staffurth J, Henry A, Hassan S, Brown S, Cruickshank C, Syndikus I, Hall E.  Trials 2019, 20(Suppl 1):P-22

Successful collaboration between a Clinical Trial Unit (CTU) and the National Radiotherapy Trials Quality Assurance (RTTQA) Group to expedite opening a complex phase III trial (PIVOTALboost). Cruickshank C, Mayles H, Naismith O, Snelson N, Tree A, Staffurth J, Henry A, Hassan S, Brown S, Syndikus I, Hall E.  Trials 2019, 20(Suppl 1):P-21

Pre-trial outlining quality assurance in PIVOTALboost.  Evans E, Mayles H, Naismith O, Hall E, Tree A, Staffurth J, Syndikus I.  ASCO 2019 Genitourinary Cancers Symposium. Journal of Clinical Oncology 37, no. 7_suppl (March 01, 2019) 50-50.

Use of simulations to explore recruitment and the impact of late availability of experimental arms in the PIVOTALboost trial. Porta N, Griffin C, Syndikus I, Staffurth J, Hoskin P, Dearnaley D, Henry A, Carey B, Tree A, Lewis R, Hall E. Trials 2017;18 (S1), P51. 10).