Adjuvant hormonal treatment - the bicalutamide early prostate cancer program.

Several randomized trials have demonstrated that adjuvant medical or surgical castration may improve overall survival in patients with locally advanced prostate cancer undergoing external beam radiotherapy. After radical prostatectomy, patients with positive lymph nodes seem to benefit from adjuvant hormonal treatment rather than from treatment at the time of clinical progression in terms of overall survival. In patients with locally advanced, lymph node-negative prostate cancer, adjuvant hormonal treatment after radical prostatectomy has been demonstrated to delay progression without impact on survival. The Bicalutamide Early Prostate Cancer Program, the largest ongoing prostate cancer trial in the world, investigates the effect of early treatment with 150 mg bicalutamide compared with placebo as monotherapy or adjuvant treatment after radical prostatectomy or external beam radiotherapy. It demonstrated that early treatment with bicalutamide may delay objective progression of prostate cancer irrespective of primary treatment. Considering overall survival, however, there was an advantage only in the setting of external beam radiotherapy for locally advanced prostate cancer. In patients with localized disease who initially underwent watchful waiting, there was a trend to decreased survival in the arm immediately treated with bicalutamide. Altogether, there is no indication for treatment with bicalutamide in patients with localized disease.