EFFECT OF ANDROGEN DEPRIVATION THERAPY ON LOCAL SYMPTOMS AND TUMOR PROGRESSION IN MEN WITH METASTATIC CARCINOMA OF THE PROSTATE

Objective: To evaluate and compare the effects of medical or surgical castration combined with either nilutamide (Anandron(R)) or placebo on symptoms of local tumour progression in men with carcinoma of the pro state. Methods: The results from twin, randomised, prospective, placeb o-controlled trials were analysed. 434 patients received nilutamide 30 0 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 i njection. Before treatment, and at months 1, 3, 6 and every 6 months t hereafter, 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 a nd tumour volume were similar in both treatment groups. After treatmen t, improvement in urinary obstructive symptoms accompanied a decrease in prostate volume. The majority of men in both treatment groups repor ted an improvement in obstructive voiding symptoms. However, total adv erse events secondary to local symptoms were significantly less freque nt in the nilutamide-treated patients (20%) compared with the placebo- treated patients (35%). Only a small percentage of men in both treatme nt groups had disabling local symptoms and only 2% experienced problem s with incontinence. Conclusions: Local symptoms from primary tumour g rowth are relatively common in patients with metastatic carcinoma of t he prostate and are favourably influenced by hormonal therapy. In thes e trials, the problems resulting from local tumour progression were si gnificantly fewer in the group treated with castration plus nilutamide compared with the group treated with castration plus placebo.