FRIDAY, June 5, 2026 (HealthDay News) -- Perioperative treatment with apalutamide and androgen deprivation therapy (ADT) is beneficial for patients with high-risk localized or locally advanced prostate cancer, according to a study published online June 2 in the New England Journal of Medicine to coincide with the annual meeting of the American Society of Clinical Oncology, held from May 29 to June 2 in Chicago.
Mary‑Ellen Taplin, M.D., from the Dana-Farber Cancer Institute in Boston, and colleagues conducted a phase 3 trial involving patients with newly diagnosed high-risk localized or locally advanced prostate cancer. Participants were randomly assigned to receive ADT plus apalutamide (240 mg per day) or ADT plus placebo for six cycles before and after radical prostatectomy with pelvic lymph-node dissection (1,057 and 1,052 patients, respectively).
Patients were followed for a median of 61.7 months. The researchers found that a significantly higher percentage of patients in the apalutamide group versus the placebo group had a pathological complete response or minimal residual disease (8.9 versus 1.0 percent; odds ratio, 10.17) and metastasis-free survival (probability of metastasis-free survival at five years, 78.2 versus 73.5 percent; hazard ratio for distant metastasis or death, 0.80). ADT plus apalutamide was significantly favored over ADT plus placebo for event-free survival, time to first subsequent treatment, and time to distant metastasis.
"We have a paradigm-changing phase 3 clinical trial," Taplin said in a statement. "This type of treatment regimen that combines systemic therapy with surgery is standard in other aggressive cancers and now has proven benefit for patients with high-risk localized or locally advanced prostate cancer."
Several authors disclosed ties to biopharmaceutical companies, including Johnson & Johnson, which manufactures apalutamide and funded the study.
