- Adding docetaxel-based chemotherapy to standard androgen-deprivation therapy and radiotherapy (ADT+RT) improves OS in high-risk nonmetastatic prostate cancer (PCa).
- Data also show improved disease-free survival (DFS) and reduction in the rate of distant metastasis.
Why this matters
- Findings represent a new option for select men with high-risk localized PCa.
- Phase 3, randomized NRG Oncology RTOG 0521 study of 563 patients with high-risk nonmetastatic PCa, randomly assigned to standard long-term ADT+RT with or without adjuvant docetaxel+prednisone.
- Funding: National Cancer Institute; Sanofi.
- Median follow-up, 5.7 years.
- Patients in the ADT+RT+docetaxel group showed significant improvement in the:
- 4-year OS rate (93.3% vs 88.7%; HR, 0.69; P=.034).
- 6-year distant metastasis rate (9.1% vs 14.0%; HR, 0.60; P=.044).
- 6-year DFS rate (65.4% vs 54.9%; HR, 0.76; P=.043).
- 5-year PSA failure-free rates were similar between groups (P=.19).
- Hematologic toxicities were higher in the ADT+RT+docetaxel group.
- Treatment was well tolerated in both groups.
- Open-label design.