A collaborative multicenter trial was conducted by 17 Italian groups to verify whether the so-called total
androgen blockade obtained with
luteinizing hormone releasing hormone (
LHRH) analogs combined with
antiandrogens is more effective than conventional monotherapy in the treatment of advanced
prostatic cancer. A total of 328 previously untreated patients were evaluated: 163 patients received
Zoladex depot alone, 3.6 mg subcutaneously every 28 days, and 165 patients received
Zoladex depot plus
cyproterone acetate (CPA), 200 mg/day orally. The follow-up period ranged from 41-251 weeks. Treatment was well tolerated, and side-effects in both groups mainly comprised loss of libido and erections,
hot flashes and breast swelling and tenderness. There was no significant difference in objective response after 6, 12 and 24 months of treatment between the 2 groups. Median time to
disease progression was comparable in both groups: 55 weeks in the
Zoladex group and 54 weeks in the
Zoladex plus CPA group. The time to
disease progression and the survival distribution was comparable in both groups. Although there were no significant differences in the overall subjective response to both treatments, a faster improvement, with respect to
pain and performance status was noted in the
Zoladex plus CPA group (8 weeks) compared to
Zoladex alone (12 weeks). The addition of
antiandrogen, by inhibiting the initial elevation of plasma
testosterone, may prevent the disease flare-up which occurs in a small number of patients during the first few days of treatment with
LHRH analogs alone.(ABSTRACT TRUNCATED AT 250 WORDS)