Objective: To evaluate and compare the effects of medical or surgical castration combined with either nilutamide (Anandron®) or placebo on symptoms of local tumour progression in men with carcinoma of the prostate. Methods:The results from twin, randomised, prospective, placebo-controlled trials were analysed. 434 patients received nilutamide 300 mg/day for 1 month and 150 mg thereafter, and 434 received a matched placebo from either the day of orchidectomy or the first leuprolide injection. Before treatment, and at months 1, 3, 6 and every 6 months thereafter, urinary obstruction and tumour volume were evaluated. Data on adverse or intercurrent events affecting the urological system were documented. Results: Before treatment, urinary obstructive symptoms and tumour volume were similar in both treatment groups. After treatment, improvement in urinary obstructive symptoms accompanied a decrease in prostate volume. The majority of men in both treatment groups reported an improvement in obstructive voiding symptoms. However, total adverse events secondary to local symptoms were significantly less frequent in the nilutamide-treated patients (20%) compared with the placebo-treated patients (35%). Only a small percentage of men in both treatment groups had disabling local symptoms and only 2% experienced problems with incontinence. Conclusions: Local symptoms from primary tumour growth are relatively common in patients with metastatic carcinoma of the prostate and are favourably influenced by hormonal therapy. In these trials, the problems resulting from local tumour progression were significantly fewer in the group treated with castration plus nilutamide compared with the group treated with castration plus placebo.

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