Abstract
The Early Prostate Cancer (EPC) Programme was designed to evaluate the efficacy and tolerability of bicalutamide (‘Casodex’) 150 mg in addition to standard care (radical prostatectomy, radiotherapy, or watchful waiting) in patients with early stage prostate cancer. A total of 8113 men with localised or locally advanced prostate cancer and negative bone scans were recruited. Patients were randomised to receive either bicalutamide 150 mg per day ( n=4052) or placebo ( n=4061) once daily, in addition to standard care. The primary endpoints for the programme are time to objectively confirmed progression and overall survival. Secondary endpoints include time to doubling of prostate-specific antigen (PSA) and tolerability. The tolerability profile of bicalutamide 150 mg was closely related to its pharmacology, with gynaecomastia (66%) and breast pain (73%) the most frequently reported adverse events. The majority of the gynaecomastia (70%) and breast pain (90%) events improved or resolved following withdrawal from therapy. Bicalutamide 150 mg significantly reduced the risk of objective progression by 42% ( p⪡0.0001) compared with standard care alone. This effect was seen in patients with localised disease (28% reduction; p<0.001) and locally advanced disease (54% reduction; p<0.001), and was also seen regardless of the type of standard care received. In addition, bicalutamide 150 mg plus standard care reduced the risk of PSA doubling by 59% ( p⪡0.0001), and the incidence of bone metastases by 33% ( p<0.0001), compared with patients receiving placebo plus standard care. After a median follow-up of 3 years, there was no significant difference in overall survival between the treatment groups ( p=0.43); however, both progression and survival continue to be followed in these ongoing studies. In conclusion, immediate bicalutamide 150 mg treatment, either alone or as an adjuvant to treatment of curative intent, significantly reduces the risk of disease progression in patients with localised or locally advanced prostate cancer.
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