Bicalutamide ('Casodex') 150 mg in addition to standard care in patients with nonmetastatic prostate cancer: updated results from a randomised double-blind phase III study (median follow-up 5.1 y) in the early prostate cancer programme

Prostate Cancer Prostatic Dis. 2005;8(2):194-200. doi: 10.1038/sj.pcan.4500799.

Abstract

Trial 24 is one of three placebo-controlled trials within the ongoing bicalutamide ('Casodex') Early Prostate Cancer (EPC) programme evaluating bicalutamide 150 mg/day in addition to radical prostatectomy, radiotherapy or watchful waiting for T1b-4, any N, M0 prostate cancer. In Trial 24, at 5.1 y median follow-up, the addition of bicalutamide significantly (P < 0.0001) improved objective progression-free survival (PFS) and prostate-specific antigen PFS compared with standard care alone. There was no significant difference in overall survival (P = 0.746). In the context of the whole EPC programme, long-term bicalutamide is not appropriate for localised disease, yet provides advantages in delaying disease progression in patients with locally advanced prostate cancer.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Anilides / administration & dosage
  • Anilides / adverse effects
  • Anilides / therapeutic use*
  • Antineoplastic Agents / administration & dosage
  • Antineoplastic Agents / adverse effects
  • Antineoplastic Agents / therapeutic use*
  • Double-Blind Method
  • Humans
  • Male
  • Middle Aged
  • Nitriles
  • Placebos
  • Prostatectomy
  • Prostatic Neoplasms / drug therapy*
  • Prostatic Neoplasms / radiotherapy
  • Prostatic Neoplasms / surgery
  • Survival Analysis
  • Tosyl Compounds
  • Treatment Outcome

Substances

  • Anilides
  • Antineoplastic Agents
  • Nitriles
  • Placebos
  • Tosyl Compounds
  • bicalutamide