- In patients with newly diagnosed localized prostate cancer, neoadjuvant and concurrent initiations of short-term androgen-deprivation therapy (ADT) with dose-escalated radiotherapy (RT) yield similar biochemical recurrence-free survival (bRFS), OS, and late radiotherapy-related toxicities.
Why this matters
- Dose-escalated radiotherapy with ADT is a standard definitive treatment for localized prostate cancer, but their optimal sequencing is unclear.
- Phase 3 randomized trial of 432 patients with newly diagnosed localized prostate cancer with Gleason score ≤7, clinical stage T1b-T3a, and PSA
- Participants were randomly assigned to neoadjuvant and concurrent ADT for 6 months starting 4 months before RT (neoadjuvant group) or concurrent and adjuvant ADT for 6 months starting simultaneously with RT (concurrent group).
- Primary endpoint: bRFS.
- Funding: AstraZeneca.
- Median follow-up was 146 months at data cutoff.
- Neoadjuvant vs concurrent group showed no significant difference in:
- 10-year bRFS rates were 80.5% vs 87.4% (HR, 0.66; P=.09).
- 10-year OS rates were 76.4% vs 73.7% (HR, 0.94; P=.7).
- 3-year incidence of late RT-related grade ≥3 gastrointestinal (2.5% vs 3.9%) or genitourinary toxicity (2.9% vs 2.9%).
- Open-label design.