PACE

International randomised study of prostatectomy vs stereotactic body radiotherapy (SBRT) and conventional radiotherapy vs SBRT for organ-confined prostate cancer.

Disease site: Prostate cancer, urological cancers

Treatment modality: Radiotherapy and surgery

Status: Closed to recruitment

Trial details

PACE is a multicentre, international phase 3 randomised controlled study to assess whether hypofractionated stereotactic body radiotherapy (SBRT) offers therapeutic benefit over prostatectomy or conventional radiotherapy in men with organ-confined prostate cancer.

There are 3 cohorts (independently powered randomised sub-trials): PACE-A, PACE-B and PACE-C.

PACE-A is comparing SBRT to surgery to remove the prostate gland and will compare the bowel and bladder side effects from both treatments. Both treatments will also be compared to look at how long men live after each treatment without any sign of their cancer coming back.

PACE-B and PACE-C are comparing SBRT to ordinary radiotherapy and will look at how long men live after each treatment without any sign of their cancer coming back, as well as trying to find out more about the side effects of each treatment. PACE-B is for patients who are not receiving hormone therapy; PACE-C is for intermediate and high risk patients requiring 6 months of hormone therapy.

PACE A will recruit 234 patients considered candidates for surgery, as agreed by both physician and patient. The participants will be randomised to receive either:

• Prostatectomy; or
• Prostate SBRT delivered with 36.25 Gy in 5 fractions.

PACE B recruited 874 patients and reached its target so is not currently recruiting any further patients. In PACE-B, patients not considered candidates for surgery, or that declined surgery were randomised to receive either:

• Conventional radiotherapy (investigators choice between 78 Gy in 39 fractions or 62 Gy in 20 fractions); or
• Prostate SBRT delivered with 36.25 Gy in 5 fractions.

PACE C will recruit 1182 patients who are not considered candidates for surgery, or who have declined surgery. These participants will be randomised to receive either:

• Conventional radiotherapy (60 Gy in 20 fractions); or
• Prostate SBRT delivered with 36.25 Gy in 5 fractions.

Following completion of trial treatment, all participants will be followed up for 10 years.

Study results

PACE-B Main Results - Lay Summary 

Further information

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

ICR-CTSU Scientific Lead: Professor Emma Hall

Trial management contact: [email protected]

ISRCTN: 17627211 

Sponsor: The Royal Marsden NHS Foundation Trust

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

View PACE on the National Institute for Health Research website: NIHR - Be Part Of Research

A plain English summary of PACE is available from Cancer Research UK

RTQA treatment guidelines

PACE is an ongoing clinical trial.  Acute toxicity results for the PACE-B cohort have been published in The Lancet Oncology and are linked in the publications and presentations section below.

The PACE Radiotherapy Planning and Treatment Guidelines, developed by the National Radiotherapy Clinical Trials Quality Assurance Team and the PACE Trial Management Group, include details for SBRT treatment (36.25Gy in 5 fractions).

Protocol

Protocol

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”