A PROSPECTIVE, RANDOMIZED STUDY TO COMPARE GOSERELIN ACETATE (ZOLADEX(R)) VERSUS CYPROTERONE-ACETATE (CYPROSTAT(R)) VERSUS A COMBINATION OFTHE 2 IN THE TREATMENT OF METASTATIC PROSTATIC-CARCINOMA

A prospective randomised study was performed to test the hypothesis th at total androgen ablation, achieved by combining an LHRH analogue, go serelin acetate (Zoladex(R)), with an antiandrogen, cyproterone acetat e (Cyprostat(R)), is more effective than conventional monotherapy in d elaying the time to progression of metastatic prostatic cancer, 525 pa tients were recruited at 18 UK centres between May 1986 and January 19 89, 175 patients being allocated to each arm, Patients were clinically and biochemically assessed at 1, 2, 3, 6, 9 and 12 months after initi ation of therapy and then every 6 months until a maximum duration of 4 8 months. There was no statistically significant difference in terms o f median time to progression between the combination treatment arm and either monotherapy arm, although there was a statistically significan t difference between goserelin acetate alone and cyproterone acetate a lone, in favour of goserelin acetate (p = 0.016), All treatment regime ns were well tolerated and cyproterone acetate reduced both tumour fla re reactions and hot flushes in patients receiving goserelin acetate. It is concluded that total androgen ablation using cyproterone acetate (300 mg/day) and goserelin acetate (3.6 mg every 28 days) confers no advantage in terms of time to progression, to conventional monotherapy , but can reduce certain side effects caused by LHRH analogue treatmen t alone.