Effectiveness of Zometa® treatment for the prevention of bone metastases in high risk prostate cancer patients. A randomized, open-label, multicenter study of the European Association of Urology (EAU) in cooperation with the Scandinavian Prostate Cancer Group (SPCG) and the Arbeitsgemeinschaft Urologische Onkologie (AUO)
Tx,Nx,M0,ECOG=0, life expectancy > 6 months, ± intended curative treatment, hormone naïve and starting castration therapy, and at least one of the following: Gleason = 8 -10, pN or PSA >= 20 on diagnosis
Vitamin D 400 IU and Calcium 500 mg p.o. per day ± Zoledronic acid 4 mg i. v. every 3 months for 48 months.
Primary study objective
Rate of bone metastases assessed by bone scan and x-ray after 48 months
Number of patients
SPCG 250, total nr. 1300
EAU office in Arnheim. Monitoring by national arrangements