PACE

What is the study about?  

PACE investigates treatment options for prostate cancer. 

People with prostate cancer which hasn’t spread elsewhere in the body can have surgery to remove the prostate gland and the cancer inside it, or radiotherapy to kill off the cancer without removing the prostate gland. Radiotherapy may be given on its own or after starting a course of hormone therapy. 

Radiotherapy for prostate cancer is normally given over four to seven weeks. Stereotactic body radiotherapy – SBRT – is a new radiotherapy technique which allows treatment to be given over five days. 

PACE includes three separate studies: 

• PACE-A compares surgery to remove the prostate with SBRT

• PACE-B compares standard prostate radiotherapy with SBRT

• PACE-C compares standard prostate radiotherapy with SBRT for people receiving hormone therapy

Who is included in the study?

• PACE-A includes 123 people with prostate cancer that does not have a high risk of returning after treatment

• PACE-B includes 874 people receiving radiotherapy for prostate cancer

• PACE-C includes 1208 people receiving hormone therapy followed by radiotherapy for prostate cancer 

Participants are enrolled at hospitals across the UK, Ireland, Canada and New Zealand.  

What are the study treatments? What does the study involve?

Everyone who joins PACE-A will be in one of two treatment groups: 

• Surgery to remove the prostate

• Prostate SBRT given over five days

Everyone who joins PACE-B will be in one of two treatment groups: 

• Standard prostate radiotherapy given over four to seven weeks

• Prostate SBRT given over five days 

Everyone who joins PACE-C be in one of two treatment groups: 

• Standard prostate radiotherapy given over four weeks

• Prostate SBRT given over five days 

Everyone in PACE-C will also start hormone therapy before their radiotherapy. 

All PACE 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.

Study results

PACE-B found that the side effects of SBRT experienced by participants during and up to two years after treatment were similar to side effects of standard radiotherapy. It also confirmed that SBRT was similarly successful to standard radiotherapy at preventing cancer from returning after treatment, with over 95 out of 100 people in each treatment group remaining free of cancer five years after treatment. 

PACE-B plain English summary - Acute toxicity

PACE-B plain English summary - Late toxicity

Results of PACE-A and PACE-C will be published when available. 

Further information for participants

PACE-A Patient information sheet

PACE-B Patient information sheet - 4 weeks

PACE-B Patient information sheet - 8 weeks

PACE-C Patient information sheet

A detailed summary is available on Cancer Research UK’s website.

Our team are unable to offer any medical advice. If you are interested in finding out more about the trial or the treatments involved, please talk to your hospital doctor or GP about whether they may be a suitable option for you. 

Further information for healthcare professionals  

Protocol

QA guidelines 

Contact details and regulatory information

Chief Investigator: Professor Nicholas van As, The Royal Marsden NHS Foundation Trust 

ICR-CTSU scientific lead: Professor Emma Hall 

Trial management contact: [email protected] 

Sponsor: The Royal Marsden NHS Foundation Trust 

Funding: Accuray, Varian, and The Royal Marsden Cancer Charity 

Trial identifiers

REC reference: LO/11/1915 

ISRCTN17627211 

ClinicalTrials.gov: NCT01584258 

Publications and presentations

D.H. Brand et al. “Intensity-modulated fractionated radiotherapy versus stereotactic body radiotherapy for prostate cancer (PACE-B): acute toxicity findings from an international, randomised, open-label, phase 3, non-inferiority trial.” Lancet Oncol. 2019 Nov;20(11):1531-1543.

Lay summary of Lancet Oncology November 2019 paper

D.H. Brand et al. “Optimal patient selection for stereotactic body radiotherapy - Authors' reply.”  Lancet Oncol. 2019 Dec;20(12):e662.

Presentation at GU ASCO (genitourinary cancer focus, February 2019) N van As et al. “PACE: Analysis of Acute Toxicity in PACE-B, an International Phase III Randomised Controlled Trial Comparing Stereotactic Body Radiotherapy (SBRT) to Conventionally Fractionated or Moderately Hypofractionated External Beam Radiotherapy (CFMHRT) for Localised Prostate Cancer (LPCa).”

Presentation at ASTRO (radiation oncology community, September 2019).  D.H. Brand et al. “Patient Reported Acute Toxicity in PACE-B, an International Phase III Randomised Controlled Trial Comparing Stereotactic Body Radiotherapy to Conventionally Fractionated or Moderately Hypofractionated Radiotherapy (CFMHRT) for Localised Prostate Cancer”