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Radiation Therapy

PACE-A: Prostatectomy vs prostate SBRT 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

PACE 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.Check my eligibility

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.See study design

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.

PACE Trial 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.

PACE Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

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 outcome measures

All arms: Clinician reported acute toxicity

All arms: Clinician reported late toxicity

All arms: Disease-specific and overall survival

+4 more

PACE 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

Find a Location

Who is running the clinical trial?

Royal Marsden NHS Foundation TrustLead Sponsor

308 Previous Clinical Trials

10,121,276 Total Patients Enrolled

20 Trials studying Prostate Cancer

60,834 Patients Enrolled for Prostate Cancer

The Institute of Cancer Research, Sutton, Surrey, UKUNKNOWN

Alison Tree, MDPrincipal InvestigatorRoyal Marsden NHS Foundation Trust, London, United Kingdom

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

At how many different venues can this clinical trial be accessed?

"This clinical trial is being conducted at 68 different sites worldwide, including notable locations such as Lakeridge Health in Oshawa, Western General in Edinburgh, and The Beatson in Glasgow. Additionally, there are several other participating locations across the globe."

Answered by AI

Are there any ongoing opportunities for patients to participate in this medical trial?

"As per the information provided on clinicaltrials.gov, this particular clinical trial is not currently in the recruitment phase. Its initial posting dates back to August 7th, 2012 and it was last updated on January 18th, 2024. However, please note that there are currently 1315 other ongoing trials actively seeking participants at present."

Answered by AI

Has the PACE-C study comparing conventionally fractionated radiation therapy to prostate stereotactic body radiotherapy received approval from the FDA?

"Based on our team's evaluation at Power, the safety of PACE-C: Conventionally Fractionated RT vs Prostate SBRT is rated as 3. This rating corresponds to it being a Phase 3 trial with evidence supporting its efficacy and multiple rounds of data confirming its safety."

Answered by AI

What are the anticipated results that researchers hope to achieve through this experimental investigation?

"The primary objective of this clinical trial, which will be evaluated over a 2-year post-treatment period, is to determine the rate of freedom from biochemical or clinical failure in PACE-B and PACE-C. Secondary outcomes include assessing acute toxicity reported by clinicians using CTCAE and RTOG scales (for SBRT and conventional RT patients) or Clavien scale (for surgical patients), evaluating late toxicity reported by clinicians based on CTCAE and RTOG criteria (only for SBRT and conventional RT patients), and determining the rate of freedom from biochemical or clinical failure specifically in PACE-A. Biochemical progression is defined"

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Prostate Advances in Comparative Evidence

2012. "Prostate Advances in Comparative Evidence". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT01584258.