Oudard S, et al. - In this open-label, phase 3, randomized superiority trial, researchers evaluated the benefit of androgen-deprivation therapy (ADT) plus docetaxel vs ADT alone in patients with rising levels of prostate-specific antigen (PSA) following primary local therapy and high-risk factors, but without signs of metastatic disease. In patients with high-risk prostate cancer and rising PSA levels, combined ADT plus docetaxel therapy with curative intent did not improve PSA progression-free survival (PSA-PFS) significantly vs ADT alone and did not demonstrate metastatic disease.

Methods

• This trial comparing ADT plus docetaxel vs ADT alone enrolled patients from 28 centers in France between June 4, 2003 and September 25, 2007; final follow-up was carried out on April 12, 2017 and analysis was conducted between May 2 and July 31, 2017.
• Patients received primary local therapy for prostate cancer, had increased levels of PSA, and were considered to be at high risk for metastatic disease.
• Stratification was based on prior local therapy and PSA-level doubling time (≤6 vs >6 months), and intention-to-treat analysis was utilized.
• For this investigation, patients were randomly assigned to receive ADT (1 year) plus docetaxel, 70 mg/m² (every 3 weeks [6 cycles]), or ADT alone (1 year).
• PSA-PFS was the primary outcome; PSA response, radiologic PFS, overall survival, safety, and quality of life were included secondary outcomes.

Results

• In total, 254 patients were randomized (1:1) to the ADT plus docetaxel arm (median age, 64 years) and the ADT alone arm (median age, 66 years).
• The median PSA-PFS was 20.3 (95% CI, 19.0-21.6) months in the ADT plus docetaxel arm vs 19.3 (95% CI, 18.2-20.8) months in the ADT alone arm (hazard ratio [HR], 0.85; 95% CI, 0.62-1.16; P=.31) at a median follow-up of 30.0 months.
• There was no significant between-arm difference in radiologic PFS (HR, 1.03; 95% CI, 0.74-1.43; P=.88) at a median follow-up of 10.5 years.
• Neutropenia (60 of 125 patients [48.0%]), febrile neutropenia (10 [8.0%]), and thrombocytopenia (4 [3.0%]) were the most common grade 3 or 4 hematologic toxic effects in the ADT plus docetaxel arm.
• In overall quality of life, there was no significant between-arm difference.