Bicalutamide ('Casodex') 150mg in addition to standard care in patients with nonmetastatic prostate cancer: Updated results from a randomised double-blind phase III study (median follow-up 5.1y) in the early prostate cancer programme
Date
2005
Authors
Wirth M.
Tyrrell C.
Delaere K.
Sanchez-Chapado M.
Ramon J.
Wallace D.M.A.
Hetherington J.
Pina F.
Heyns C.
Borchers T.
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Journal ISSN
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Publisher
Abstract
Trial 24 is one of three placebo-controlled trials within the ongoing bicalutamide ('Casodex'+) Early Prostate Cancer (EPC) programme evaluating bicalutamide 150mg/day in addition to radical prostatectomy, radiotherapy or watchful waiting for T1b -4, any N, M0 prostate cancer. In Trial 24, at 5.1y 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. © 2005 Nature Publishing Group. All rights reserved.
Description
Keywords
bicalutamide, placebo, prostate specific antigen, anilide, antineoplastic agent, accidental injury, add on therapy, advanced cancer, arthralgia, article, backache, body weight disorder, cancer growth, cancer radiotherapy, cancer staging, cancer survival, clinical trial, constipation, controlled clinical trial, controlled study, disease free survival, double blind procedure, follow up, gynecomastia, hematuria, hernia, hot flush, human, hypercholesterolemia, impotence, long term care, major clinical study, male, mastalgia, pain, patient care, phase 3 clinical trial, priority journal, prostate cancer, prostatectomy, randomized controlled trial, rash, somnolence, statistical analysis, urinary tract infection, urine incontinence, weight gain, adult, aged, middle aged, multicenter study, prostate tumor, survival, treatment outcome, Adult, Aged, Aged, 80 and over, Anilides, Antineoplastic Agents, Double-Blind Method, Humans, Male, Middle Aged, Placebos, Prostatectomy, Prostatic Neoplasms, Survival Analysis, Treatment Outcome
Citation
Prostate Cancer and Prostatic Diseases
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