After staging pelvic lymph node dissection, patients with high-risk prostate cancer randomly received androgen deprivation therapy (ADT) (3 years) + DE (4 cycles of docetaxel 70 mg/m2/3 weeks + estramustine 10 mg/kg/d d1-5) or ADT alone. Local therapy was administered at 3 months.
Four hundred and thirteen patients were accrued: T3-T4 (67 % ), Gleason score ? (42 % ), PSA >20 ng/mL (59 % ), pN+ (29 % ). In the chemotherapy arm, 94 % of patients received the planned four cycles of docetaxel. Local treatment consisted of radiotherapy in 358 patients (87 % ) (median dose 74 Gy in both arms). ADT was given for 36 months in both arms. A PSA response (PSA ?.2 ng/mL after 3 months of treatment) was obtained in 34 % and 15 % in the ADT + DE arm and in the ADT arm, respectively (p < 0.0001). Febrile neutropenia occurred in only 2 % . Moderate to severe hot flashes occurred less often in the ADT + DE arm (2 % versus 22 % ; p < 0.001). There was no toxicity-related death, no secondary leukaemia, and no excess second cancers. Chemotherapy had a negative impact on quality of life (global health status, p = 0.01; fatigue, p = 0.003; role functioning, p = 0.003; social functioning, p = 0.006) at 3 months but this effect disappeared at 1 year.
Docetaxel-estramustine can be combined safely with standard therapy in high-risk prostate cancer, with a promising PSA response rate and no negative impact on quality of life after 1 year. Long-term follow-up is required to assess the impact on relapse and survival.