RADICALS-RT: timing of radiotherapy after radical prostatectomy
Giving radiotherapy to every man with risk factors immediately after prostatectomy was no better than waiting and treating only those whose PSA rose, so early salvage radiotherapy became the standard and spared many men unnecessary treatment.
Overview
Phase 3 trial of 1,396 men after radical prostatectomy with at least one risk factor (pT3/4, Gleason 7 to 10, positive margins or preoperative PSA of 10 or more) randomised to adjuvant radiotherapy within six months or an observation policy with early salvage radiotherapy at biochemical failure.
Five-year biochemical progression-free survival was 85 percent with adjuvant and 88 percent with salvage policy (hazard ratio 1.10, no difference), with only a third of the salvage group receiving radiotherapy by five years and more urinary and bowel toxicity in the adjuvant group; a meta-analysis with two similar trials (ARTISTIC) confirmed the result.
- Five-year biochemical progression-free survival 85 percent (adjuvant) vs 88 percent (salvage policy).
- Only 33 percent of the salvage-policy group had received radiotherapy at five years.
Observation with early salvage radiotherapy at PSA recurrence is standard after prostatectomy, avoiding radiotherapy in most men who would never have needed it.
- Men with the highest-risk features (multiple adverse factors) were under-represented.
- Longer follow-up for metastasis-free survival is pending.