- Initial salvage radiotherapy (SRT) prolongs time to treatment failure (TTF) of bicalutamide in patients with localized prostate cancer who had PSA failure after radical prostatectomy (RP).
Why this matters
- There is no standard treatment for patients with PSA failure after RP.
- Multicenter, randomized, open-label, phase 3 trial of 210 patients with localized prostate cancer who had PSA failure after RP.
- Patients were randomly assigned to salvage hormone therapy (SHT; bicalutamide) or SRT±SHT.
- Primary endpoint: TTF of bicalutamide.
- Funding: Ministry of Health, Labour and Welfare, Japan.
- Median follow-up, 5.5 years.
- Median TTF of BCL was significantly longer in the SRT±SHT vs SHT group:
- 8.6 (95% CI, 4.5-6.6) years vs 5.6 (95% CI, 7.2-not estimable) years.
- 5-year freedom from treatment failure was higher in the SRT±SHT group:
- 69.7% vs 57.0% SHT group.
- HR, 0.555 (P=.001).
- Similar 5-year relapse-free survival (HR, 0.904; P=.77) and 5-year OS (HR, 1.030; P=.94) between groups.
- Erectile dysfunction was the most common grade 3-4 adverse event (SHT group, 80% vs SRT±SHT group, 74%).
- Open-label design, short follow-up, and surrogate endpoint.