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Objectives: To determine the endocrine effects, efficacy and tolerability of the 3-month formulation of goserelin acetate (‘Zoladex’ 10.8-mg depot; ‘Zoladex’ is a trade mark of the AstraZeneca group of companies) in the treatment of patients with advanced prostate cancer. Methods: Between February 1996 and October 1997, this open, multicentre study enrolled 120 patients with locally advanced (T3/4) or metastatic (N+ or M1) disease, or an increase in prostate-specific antigen (PSA) level after radical prostatectomy. Patients received goserelin acetate 10.8-mg depot every 12 weeks until clinical progression or interruption for adverse events or other reasons. Results: The mean testosterone concentrations were suppressed to the castration range (≤2 nmol/l) after 4 weeks of treatment and remained suppressed throughout the study. In total, 99/115 (86%) patients had a serum PSA response, and the mean PSA value decreased significantly during treatment (p = 0.006). The mean PSA level at baseline was significantly lower in patients without disease progression compared to those who experienced disease progression (p = 0.0002). Goserelin acetate 10.8-mg depot was well tolerated and there were no injection site reactions. Conclusions: The goserelin acetate 10.8-mg depot is well tolerated with no injection site reactions. It produces PSA responses and provides reliable suppression of serum testosterone.

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A new model for the study of intra-renal reflux (IRR) is proposed. The renal pelvis of human kidneys, either obtained from cadavers or removed surgically, was injected, at increasing pressures, with dye solutions to investigate intra-renal reflux. To reproduce physiological conditions as closely as possible, arterial perfusion was performed, either continuously or by means of a peristaltic pump, so that a predetermined pressure in the vascular system could be obtained. Comparison was made between results obtained by this technique and the results reported in the literature and previously recorded by the present authors without any perfusion of the vascular system. Our results show significant diffusion of the vascular system. Our results show significant differences in the threshold of IRR compared to data from experiments in which vascular perfusion was not simultaneously performed. It can be concluded that, under physiological conditions, intrarenal flux occurs at pressures of 40 cm H2O, and pyelovenous reflux at pressures of 60-70 cm H2O.