European urology
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Randomized Controlled Trial Multicenter Study Clinical Trial
A controlled trial of Casodex (bicalutamide) vs. flutamide, each in combination with luteinising hormone-releasing hormone analogue therapy in patients with advanced prostate cancer. Casodex Combination Study Group.
Between January 1992 and September 1993, 813 patients with stage D2 prostate cancer were enrolled in a multicentre, double-blind (for antiandrogen therapy) trial and randomised to antiandrogen therapy with Casodex (bicalutamide, 50 mg once daily) or flutamide (250 mg three times daily) and to luteinising hormone-releasing hormone (LHRH) analogue therapy with Zoladex (goserelin, 3.6 mg every 28 days) or leuprolide (7.5 mg every 28 days). Time to treatment failure was the primary efficacy endpoint. At a median follow-up time of 49 weeks, there was a significant (p = 0.005) difference between groups in time to treatment failure in favour of Casodex plus LHRH analogue. ⋯ Diarrhoea led to withdrawal from therapy for 2 patients in the Casodex plus LHRH analogue group, compared with 25 patients in the flutamide plus LHRH analogue group. In conclusion, Casodex plus LHRH analogue is well tolerated and effective with an improvement in time to treatment failure over flutamide plus LHRH analogue. Survival was not dissimilar between the 2 treatment groups.
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Randomized Controlled Trial Clinical Trial
Effect of irrigating fluid on perioperative temperature regulation during transurethral prostatectomy.
Hypothermia in the immediate postoperative period is associated with postoperative instability, prolonged recovery and increased risk of myocardial ischemia in the subsequent 24 h. This study examined the effect of irrigating-fluid temperature during transurethral resection of the prostate on perioperative temperature regulation. A randomized prospective study was conducted on twenty-eight consecutive patients undergoing transurethral resections of the prostate. ⋯ The decrease from pre- to postoperative temperature was greater with cold (0.95 +/- 0.47 degrees C) than with warm (0.42 +/- 0.64 degrees C) irrigant (p = 0.01). The type of anesthesia (spinal versus general) and method of fluid warming (incubator versus level-one) did not have a significant effect on the perioperative temperature drop. Regression analysis demonstrated that the time of resection, amount of prostate resected, volume of irrigant fluid, and volume of intravenous fluid administered were not independent predictors of intraoperative temperature change.