The effect of Buserelin versus conventional antiandrogenic treatment in patients with T2-4NXM1 prostatic cancer. A prospective, randomized multicentre phase III trial. The "Danish Buserelin Study Group"

Abstract

A prospective, randomized multicentre phase III trial was undertaken to compare the effectiveness and safety of Buserelin, a gonadotropin-releasing hormone analogue (GnRHa), with conventional antiandrogenic treatment in patients with painful metastases from T2-4NXM1 prostatic cancer. Seventy-two patients received Buserelin, 22 received estrogens and 46 were subjected to orchiectomy. The trial was completed one year after allocation of the patients. No significant differences as regards 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 Buserelin and following orchiectomy. No detectable improvement of performance index was seen during treatment with estrogens. Treatment with estrogens also failed to alleviate pain or general symptoms of cancer. Tolerability, safety and compliance of Buserelin was although administered intranasally clearly evidenced as palliation of advanced symptomatic cancer and the efficacy and sideeffects were fully comparable to those following orchiectomy.