Samarium-153-Lexidronam complex for treatment of painful bone metastases in hormone-refractory prostate cancer

Urology. 2004 May;63(5):940-5. doi: 10.1016/j.urology.2004.01.034.


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 diaries recording daily pain and analgesic use were completed during a planned 16-week evaluation period. Nonresponders were informed of the treatment received after 4 weeks of treatment and, if initially treated with placebo, were allowed to receive 153Sm-lexidronam in an open-label fashion. Pain was measured using validated patient-derived visual analog scales and pain descriptor scales.

Results: 153Sm-lexidronam had positive effects on measures of pain relief compared with placebo within 1 to 2 weeks. Reductions in opioid use were recorded at weeks 3 and 4. Because nonresponders were unblinded at week 4, statistical comparisons between the arms beyond week 4 were not possible. Mild, transient bone marrow suppression was the only adverse event associated with 153Sm-lexidronam administration. The mean nadir white blood cell and platelet count (3 to 4 weeks after treatment) was 3800/microL and 127,000/microL, respectively. Counts recovered to baseline after approximately 8 weeks. No grade 4 decreases in either platelets or white bloods cells were documented.

Conclusions: These findings demonstrate that 1 mCi/kg 153Sm-lexidronam is both safe and effective for the palliation of painful bone metastases in patients with hormone-refractory prostate cancer.

Publication types

  • Clinical Trial
  • Clinical Trial, Phase III
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Aged, 80 and over
  • Bone Diseases / drug therapy*
  • Bone Diseases / etiology
  • Bone Neoplasms / drug therapy
  • Bone Neoplasms / secondary*
  • Double-Blind Method
  • Drug Combinations
  • Humans
  • Male
  • Middle Aged
  • Organometallic Compounds / therapeutic use*
  • Organophosphorus Compounds / therapeutic use*
  • Pain / drug therapy*
  • Pain / etiology
  • Pain Measurement
  • Prospective Studies
  • Prostatic Neoplasms*
  • Radioisotopes / adverse effects
  • Radioisotopes / therapeutic use*
  • Samarium / adverse effects
  • Samarium / therapeutic use*


  • Drug Combinations
  • Organometallic Compounds
  • Organophosphorus Compounds
  • Radioisotopes
  • Samarium