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Radiation Therapy

Surgery vs Radiotherapy for Prostate Cancer (PACE Trial)

Phase 3

Waitlist Available

Led By Alison Tree, MD

Research Sponsored by Royal Marsden NHS Foundation Trust

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Low risk: Clinical stage T1-T2a and Gleason ≤ 6 and PSA < 10 ng/ml, or Clinical stage T2b orT2c

WHO performance status 0 - 2

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 10 years

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is studying different treatment options for prostate cancer. It involves patients with low, intermediate, and high risk prostate cancer. The patients are divided into different groups based on their suitability for surgery as a

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Possible side effects include urinary problems like difficulty peeing or leakage, bowel issues such as diarrhea or discomfort, sexual dysfunction including trouble getting erections, fatigue from radiation therapy, and potential complications from surgery.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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I can take care of myself and perform light activities.

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My prostate cancer has a Gleason score of 3+4 or less.

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My cancer is in an early stage and hasn't spread to distant parts.

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My prostate cancer has a Gleason score of 3+4.

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I am a man aged 18 or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 10 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~10 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

PACE-A: Co-primary patient reported outcomes of urinary incontinence and bowel bother

PACE-B and PACE-C: Freedom from biochemical or clinical failure

Secondary study objectives

All arms: Clinician reported acute toxicity

All arms: Clinician reported late toxicity

All arms: Disease-specific and overall survival

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

3Treatment groups

Active Control

Group I: PACE-A: Prostatectomy vs prostate SBRTActive Control2 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 SBRTActive Control2 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 SBRTActive Control2 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.

0 / 6Eligibility criteria met