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Purpose: A randomized, double-blind, dose finding, placebo controlled, parallel group clinical study was done to determine the incidence of prostate cancer in men with high grade prostatic intraepithelial neoplasia treated with toremifene., Materials and Methods: A total of 514 patients with high grade prostatic intraepithelial neoplasia and no evidence of prostate cancer on screening biopsy were randomized to 20, 40 or 60 mg toremifene, or placebo daily for 12 months. Patients underwent re-biopsy at 6 and 12 months., Results: The number of evaluable patients, that is those with 1 on study biopsy who were compliant, was 447. The cumulative risk of prostate cancer was decreased in patients on 20 mg toremifene compared with placebo (24.4% vs 31.2%, p <0.05). The annualized rate of prevention was 6.8 cancers per 100 men treated. In patients with no biopsy evidence of cancer at baseline and 6 months, the 12-month incidence of prostate cancer was decreased by 48.2% with 20 mg toremifene compared with placebo (9.1% vs 17.4%, p <0.05). The 20 mg dose was most effective but cumulative and 12-month incidences of prostate cancer were lower for each toremifene dose vs placebo with a cumulative risk of 29.2% and 28.1%, and a 12-month incidence of 14.3% and 13.0% for 40 and 60 mg, respectively. Gleason scores were similar across treatments. The overall incidence of drug related and serious adverse events did not differ between any of the toremifene groups and the placebo group., Conclusions: Toremifene decreased the incidence of prostate cancer by 1 year and had a tolerability profile comparable to that of placebo in a high risk population.

Purpose: The UroVysion fluorescence in situ hybridization assay (UroVysion Bladder Cancer Recurrence Kit, Vysis, Inc., Downers Grove, Illinois) is a multi-target assay that detects aneuploidy of chromosomes 3, 7 and 17, and loss of the 9p21 band in exfoliated cells in urine from patients with transitional cell carcinoma. We performed 2 multicenter trials. In 1 trial we compared the sensitivity of the FISH assay to the BTA Stat test (Bion Scientific, Redmond, Washington) and voided cytology in the detection of transitional cell carcinoma. In a separate study of healthy volunteers and patients with other (nontransitional cell carcinoma) conditions we determined the specificity of the FISH assay., Materials and Methods: A total of 176 patients with transitional cell carcinoma in the previous 9 months provided voided urine before cystoscopy. Each specimen was split, preserved and shipped to a central laboratory where all 3 tests were performed. All sites were blinded to results. Sensitivity calculations were based on central pathology review of resected tissue. Specificity was determined by testing 275 volunteers who were healthy and with nontransitional cell carcinoma conditions., Results: The 21 sites enrolled 176 patients with a history of transitional cell carcinoma, with 62 recurrences while undergoing surveillance. Overall sensitivities (with 95% CI) were FISH 71% (95% CI 58 to 82), BTA Stat test 50% (37 to 63) and cytology 26% (16 to 39). FISH was negative in 260 of the 275 healthy volunteers or patients with no history of transitional cell carcinoma (specificity 94.5%)., Conclusions: Sensitivity of the FISH assay is superior to that of cytology and at least equivalent to the BTA Stat test in detecting recurrent transitional cell carcinoma. Its specificity approaches that of cytology. Further testing of its clinical use is warranted.

Purpose: The safety and efficacy of treating renal transplant ureteral stenosis with the Acucise endoureterotomy catheter are described., Materials and Methods: We treated 4 women and 3 men 31 to 63 years old (mean age 45) with Acucise endoureterotomy for distal (6) and proximal (1) ureteral stenosis. Diagnosis was based on increasing serum creatinine and hydronephrosis on ultrasound, and confirmed by antegrade nephrostogram. One patient had recurrence and, therefore, 8 procedures were performed. Mean followup was 13 months (range 7 to 21)., Results: Technical success was 100%. One patient had a recurrent stricture and was successfully re-treated. Of the patients 3 had chronic rejection and renal failure, and 4 had stable renal function. All ureters remain patent to date., Conclusions: Treatment of short ureteral stenosis with Acucise endoureterotomy in a renal transplant is safe and effective. Furthermore, it can be performed in an ambulatory setting with minimal morbidity. This procedure should be considered as the initial approach for distal ureteral stenosis in the transplanted kidney.

Objectives: We evaluated the relation of vesicoureteral reflux, pretransplant nephrectomy, and prior ureteral reimplant with respect to posttransplant urinary tract infection and graft survival., Methods: From 1984 to 1995, 820 renal transplants were performed. Thirty-six (4%) patients had documented vesicoureteral reflux. The patients were divided into three groups: Group I, N = 10 (28%) underwent ureteral reimplantation prior to transplantation; Group II, N = 8 (22%) had bilateral nephrectomy prior to transplantation; and Group III, N = 18 (50%) had persistent reflux at the time of transplantation., Results: Graft survival at 3 years was 50% (18/36). Patient survival was 94% (34/36). The overall incidence of urinary tract infection was 56% (20/36). Complicated urinary tract infection was seen in 28% (10/36) and uncomplicated urinary tract infection in 47% (17/36) of the patients. The incidence of both complicated and uncomplicated urinary tract infection was lower in Group I. However, graft survival was lower in Group I patients. Overall graft survival was significantly lower in patients with vesicoureteral reflux compared with the rest of the group., Conclusions: The incidence of urinary tract infection did not appear to be altered significantly whether the patients had bilateral nephrectomy or persistent vesicoureteral reflux. However, those patients who had ureteral reimplantation had fewer episodes of infection. Nephrectomy prior to transplantation should be performed selectively.