- Design
- Phase 2, two-centre, open-label randomised trial
- Population
- 253 men planned for radiotherapy across salvage, high-risk and oligometastatic strata
- Primary outcome
- 5-year failure-free survival
- Effect
- 66% vs 62%; HR 0.80 (one-sided 90% CI upper bound 1.04), P1 = 0.14
PSMAgRT was a phase 2, two-centre, open-label trial that randomised 262 men planned for standard radiotherapy to either standard treatment or radiotherapy intensified to every site detected on PSMA-PET. It spanned four strata: salvage after prostatectomy, high-risk primary disease, oligometastatic disease and salvage after previous radiotherapy. 253 were analysed with a median follow-up of 66 months.
Five-year failure-free survival, the primary endpoint, was 66% with PSMA-guided treatment and 62% with standard care (HR 0.80), which did not meet the trial's threshold. Freedom from biochemical progression favoured the PSMA arm (72% vs 65%; sHR 0.70), with larger differences in the high-risk (81% vs 66%) and post-prostatectomy (80% vs 68%) strata. Only one grade 3 or worse event was possibly related to dose escalation.
The subgroup signals are hypothesis-generating and are now being tested in the phase 3 PATRON trial. For now, PSMA-PET findings can reasonably inform radiotherapy planning, but the trial does not show that chasing every PSMA-positive site improves outcomes.
- Do not assume that treating every PSMA-PET-detected site improves failure-free survival; the primary endpoint was not met.
- Note the biochemical control signal in high-risk and post-prostatectomy patients, pending phase 3 results.
- Consider PSMA-guided planning in these groups within trials or multidisciplinary discussion.
- Expect little added severe toxicity from dose escalation in experienced centres.
Why it matters
PSMA-PET is spreading fast, and this is the first randomised test of whether acting on everything it shows helps.
Don't overread it
The primary endpoint was not met; subgroup benefits are exploratory.
The statistics, in plain English
A hazard ratio of 0.80 favours PSMA-guided treatment, but its upper confidence bound crossed 1, so the result could be chance. The trial used a lenient one-sided threshold typical of phase 2, and the subgroup results are weaker evidence again.
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