Prostate cancer: salvage radiotherapy delays treatment failure

  • Yokomizo A & al.
  • Eur Urol
  • 19 Dec 2019

  • curated by Deepa Koli
  • Univadis Clinical Summaries
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Takeaway

  • 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.

Study design

  • 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.

Key results

  • 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%).

Limitations

  • Open-label design, short follow-up, and surrogate endpoint.