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

Disease site: Prostate cancerurological cancers

Treatment modality: Radiotherapy and surgery

Status: Open 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 early stage, organ-confined prostate cancer.

Two randomisations (PACE A and PACE B) will run in parallel, sharing a common experimental SBRT arm. A total of 1716 low–intermediate risk patients with a histological confirmation of prostate adenocarcinoma will be recruited.

PACE A will recruit 858 patients considered candidates for surgery, as agreed by both physician and patient. The participants will be randomised to receive either:

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

PACE B will recruit 858 patients who are not considered candidates for surgery, or who have declined surgery. These participants will be 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.

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

Further information

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

ICR-CTSU Scientific Lead: Dr Emma Hall

Trial management contact: [email protected]

ISRCTN: 17627211 

Sponsor: The Royal Marsden NHS Foundation Trust

Funding: Accuray

View PACE on the UK Clinical Trials Gateway.

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

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Clinical trials

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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.