Surgery vs Radiotherapy for Prostate Cancer

(PACE Trial)

Recruiting at 67 trial locations

Overseen By Clare Cruickshank

Age: 18+

Sex: Male

Trial Phase: Phase 3

Sponsor: Royal Marsden NHS Foundation Trust

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: Varies by treatment type (e.g., 5 fractions for SBRT, 20-39 fractions for conventional RT)

2205 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is an international multicentre randomised study of low, intermediate, and high risk prostate cancer and is composed of three parallel randomisation schemes based on applicability of surgery as a treatment for the patient and risk group. Low and intermediate risk patients, for whom surgery is a consideration, are randomised to either prostatectomy or prostate SBRT. Low and intermediate risk patients, for whom surgery is not a consideration, are randomised to either conventionally fractionated radiotherapy or prostate SBRT. Intermediate and high risk patients, for whom ADT treatment is indiacted and surgery is not a consideration, are randomised to either conventionally fractionated radiotherapy or prostate SBRT. Efficacy, toxicity and quality of life outcomes will be compared across the pairs in each randomisation.

Research Team

Alison Tree, MD

Principal Investigator

Royal Marsden NHS Foundation Trust, London, United Kingdom

Nicholas van As, MD

Principal Investigator

Royal Marsden NHS Foundation Trust, London, United Kingdom

Peter Ostler, MD

Principal Investigator

Mount Vernon Cancer Centre, United Kingdom

Eligibility Criteria

Men over 18 with prostate cancer that's not spread beyond the prostate (T1c-T2c, N0-X, M0-X) and a Gleason score ≤ 3+4. They must have had at least 10 biopsy cores taken within the last year and a half, PSA levels ≤ 20 ng/ml, and a prostate size ≤ 90 cc. Men who are very sick (WHO performance status >2), or whose cancer has spread further can't join.

Inclusion Criteria

My prostate cancer is considered low risk based on its stage and tests.

My PSA test was done within the last 60 days.

I can take care of myself and perform light activities.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to receive either prostatectomy, conventionally fractionated radiotherapy, or prostate SBRT based on risk group and treatment considerations

Varies by treatment type (e.g., 5 fractions for SBRT, 20-39 fractions for conventional RT)

Follow-up

Participants are monitored for efficacy, toxicity, and quality of life outcomes

10 years

Extension/Long-term follow-up

Participants are monitored for disease-specific and overall survival, as well as progression-free survival

10 years

Treatment Details

Interventions

• Conventionally Fractionated Prostate Radiotherapy
• Laproscopic Prostatectomy
• Prostate SBRT

Trial Overview The trial is testing three treatments for different risk groups of prostate cancer: surgery called 'prostatectomy', traditional radiotherapy given over several weeks ('Conventionally Fractionated'), and high-dose radiation in fewer sessions ('Prostate SBRT'). Patients will be randomly assigned to one treatment based on their health status and cancer risk level.

Participant Groups

Group I: PACE-A: Prostatectomy vs prostate SBRT Active Control 2 Interventions

Low and intermediate risk patients, for whom surgery is considered, will be randomised to prostatectomy vs prostate SBRT delivered with 36.25 Gy in 5 fractions.

Group II: PACE-B: Conventionally Fractionated RT vs Prostate SBRT Active Control 2 Interventions

Low and intermediate risk patients, for whom surgery is not considered or who refuse surgery, will be randomised to either conventionally fractionated radiotherapy delivered to a dose of 78 Gy in 39 fractions or 62 Gy in 20 fractions vs SBRT delivered with 36.25 Gy in 5 fractions.

Group III: PACE-C: Conventionally Fractionated RT vs Prostate SBRT Active Control 2 Interventions

Intermediate and high risk patients, indicated for 6 months ADT, will be randomised to either conventionally fractionated radiotherapy delivered to a dose of 60 Gy in 20 fractions vs SBRT delivered with 36.25 Gy in 5 fractions.

Who Is Running the Clinical Trial?

Royal Marsden NHS Foundation Trust

Lead Sponsor

Trials

331

Recruited

10,150,000+

The Institute of Cancer Research, Sutton, Surrey, UK

Collaborator

Trials

1

Recruited

2,200+