Whole-pelvic radiotherapy does not improve survival in node-negative high-risk prostate cancer

Design

Meta-analysis of phase 3 randomised trials with reconstructed individual patient data

Population

5 trials, 5,172 men with node-negative high-risk localised prostate cancer

Primary outcome

Overall survival

Effect

HR 1.07 (95% CI 0.94 to 1.21), I-squared 0%

A meta-analysis pooled five phase 3 randomised trials including 5,172 men with clinically node-negative high-risk localised prostate cancer, comparing elective whole-pelvic radiotherapy with prostate-only radiotherapy. It combined published hazard ratios and reconstructed individual patient data.

Whole-pelvic radiotherapy did not improve overall survival (HR 1.07, 95% CI 0.94 to 1.21; I-squared 0%; moderate certainty). Apparent gains in biochemical or progression-free survival and metastasis-free survival depended entirely on one single-centre trial that used PSMA staging; without it, both were null. Late grade 2 or higher urinary and bowel effects were modestly more common, without a meaningful excess of severe events.

The authors conclude that routine elective pelvic irradiation is not supported. Patients at very high nodal risk staged with PSMA imaging may be a subgroup worth testing, but benefit there is unproven.

Where PSMA imaging is limited, as in much of India, this argues for caution before adding pelvic fields routinely.

• Do not assume pelvic nodal radiotherapy improves survival in node-negative high-risk disease.
• Expect a modest rise in late urinary and bowel toxicity with pelvic fields.
• Any progression benefit came from one PSMA-staged trial and is not yet reproduced.
• Discuss the uncertainty with the patient and the radiation oncologist.

Why it matters

Wider fields add toxicity without the survival gain many assume they bring.

Don't overread it

This does not rule out benefit in very high nodal-risk, PSMA-staged men, which remains untested.

The statistics, in plain English

An HR of 1.07 with an interval from 0.94 to 1.21 means no detectable survival difference. When one trial drives a pooled benefit and removing it makes the effect disappear, the overall evidence for that benefit is weak.

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