THE EFFECT OF BUSERELIN VERSUS CONVENTIONAL ANTIANDROGENIC TREATMENT IN PATIENTS WITH T(2-4)N(X)M(1) PROSTATIC-CANCER - A PROSPECTIVE, RANDOMIZED MULTICENTER PHASE-III TRIAL

A prospective, randomized multicentre phase III trial was undertaken t o compare the effectiveness and safety of Buserelin, a gonadotropin-re leasing hormone analogue (GnRHa), with conventional antiandrogenic tre atment in patients with painful metastases from T(2-4)N(x)M(1) prostat ic cancer. Seventy-two patients received Buserelin, 22 received estrog ens and 46 were subjected to orchiectomy, The trial was completed one year after allocation of the patients. No significant differences as r egards suppression of testosterone or survival were found in favour of one of the three treatment modalities, The performance index improved significantly both during the first months of treatment with Busereli n and following orchiectomy. No detectable improvement of performance index was seen during treatment with estrogens. Treatment with estroge ns also failed to alleviate pain or general symptoms of cancer. Tolera bility, safety and compliance of Buserelin was although administered i ntranasally clearly evidenced as palliation of advanced symptomatic ca ncer and the efficacy and sideeffects were fully comparable to those f ollowing orchiectomy.