- Adjuvant radiotherapy (ART) following radical prostatectomy delays biochemical recurrence in patients with prostate cancer with positive margins or extracapsular extension.
- ART carries toxicity risk, and prostate-specific antigen (PSA) recurrence-free survival (RFS) benefit does not translate to extended OS.
Why this matters
- Consensus is lacking on treatment after radical prostatectomy in this population.
- Randomized, open-label, parallel-group trial of 250 patients with prostate cancer (stage pT2 with positive margins or pT3aN0M0 without seminal vesicle invasion), randomly assigned 1:1 to either ART or observation after radical prostatectomy.
- Primary endpoint was biochemical RFS.
- Funding: The Finnish Medical Foundation, Finnish Cancer Organizations, Ida Montini Foundation; others.
- Median follow-up time was 9.3 years in the ART group and 8.6 years in the observation group.
- 10-year biochemical RFS was 82% in the ART group and 61% in the observation group (aHR, 0.30; P<.001>
- No difference was observed in 10-year OS (HR, 0.69; P=.4) and cancer-specific survival (HR, 1.00; P=1).
- 37 of 43 patients with biochemical recurrence received salvage radiotherapy.
- Grade 3 adverse event rate was significantly higher with ART (56% vs 40%; P=.016); erectile dysfunction and urinary incontinence were most common.
- 1 patient receiving ART experienced grade 4 toxicity.
- Small sample size.