OBJECTIVES: A Phase III randomized trial was designed to assess the effectiveness of
samarium-153 (153Sm)-lexidronam for palliation of bone pain in patients with hormone-
refractory prostate cancer. METHODS: A total of 152 men with hormone-refractory prostate
cancer and painful bone metastases were enrolled in a prospective, randomized, double-
blind trial comparing radioactive (153Sm) versus nonradioactive (152Sm) lexidronam
complexes. Patients were randomized (2: 1) to the radioactive (153Sm) agent. Patient …