Overview
- Data presented at the American Society of Clinical Oncology on Sunday showed a six‑month course of apalutamide (Erleada) with standard hormone suppression made patients nine times more likely to have little or no cancer at prostate surgery and reduced the risk of metastasis or death by about 20 percent.
- A longer, one‑year pre‑ and post‑surgery regimen extended the average time before patients needed further treatment to more than six years and lowered the combined risk of recurrence and death by about 29 percent.
- The randomized trial enrolled more than 2,000 men and followed them for over five years, and investigators reported a safety profile consistent with prior studies with common side effects including hot flushes, urinary incontinence and erectile dysfunction.
- Johnson & Johnson said it will engage regulators worldwide to seek approval for earlier‑stage use of Erleada, and clinicians and guideline panels will now evaluate whether to change standards of care for high‑risk localized disease.
- About 40 percent of U.S. prostate cancer cases are considered high‑risk and currently rely on surgery or radiation alone, so the findings could reduce repeat treatments for many patients while raising questions about how to weigh benefits against side effects.