PACE-NODES: A phase III randomised trial of 5 fraction prostate stereotactic body radiotherapy (SBRT) versus 5 fraction prostate and pelvic nodal SBRT

TL;DR

This study compares two radiotherapy approaches for prostate cancer to see which leads to better outcomes.

Contribution

The trial introduces a novel comparison of pelvic nodal inclusion in SBRT for high-risk prostate cancer.

Findings

Recruitment is complete with primary analysis planned for 2029.

The trial assesses toxicity, quality of life, and time to failure in two SBRT approaches.

Abstract

•PACE-NODES is a randomised trial for high-risk localised prostate cancer patients.•It will compare prostate and pelvic nodal SBRT with prostate-only SBRT.•The primary endpoint is time to biochemical or clinical failure.•Acute/late toxicity and patient-reported quality of life, will also be assessed.•Recruitment is complete with primary analysis planned for 2029.

PACE-NODES is a randomised trial for high-risk localised prostate cancer patients.

It will compare prostate and pelvic nodal SBRT with prostate-only SBRT.

The primary endpoint is time to biochemical or clinical failure.

Acute/late toxicity and patient-reported quality of life, will also be assessed.

Recruitment is complete with primary analysis planned for 2029.

PACE-NODES is a phase III randomised controlled trial for patients with high risk localised prostate cancer, planned for radical radiotherapy with at least 12 months of androgen deprivation therapy, and suitable for stereotactic body radiotherapy (SBRT). Patients are randomised to receive either prostate SBRT (control) or prostate and pelvic nodal SBRT. In both arms, treatment is given in 5 fractions delivered on alternate days over 2 weeks. The aim of the trial is to determine whether prostate and pelvic nodal SBRT can improve outcomes for this patient group compared to prostate SBRT.

Clinical trial registration: PACE NODES is registered on ClinicalTrials.gov (NCT05613023).

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