|Toxiciy Grade:||5||City/State/Province:||Pittsburgh, PA|
|Treatments:||Biologic therapy||Hospital:||University of Pittsburgh School of Medicine|
Patients: This phase 3 study involved 941 patients with non-metastatic, hormone-refractory prostate cancer. These men ranged in age from 47 to 93 years of age. The average time from their initial diagnosis of prostate cancer was a little over 7 years.
Treatment: These patients were treated with the biological therapy atrasentan or placebo. A placebo is an inactive substance given in the same form as the active drug.
Toxicity: Patients in both groups died; 22 in the atrasentan group and 16 in the placebo group. Toxicities included peripheral edema, nasal congestion, fatigue, headache, pain, and constipation. Heart failure occurred in 6.7% of patients treated with atrasentan and 3% of those treated with placebo.
Results: The median overall survival was 48.55 months (1477 days) in the group treated with atrasentan and 46.12 months (1403 days) in the group treated with placebo.
Support: This study was supported by research funds from Abbott Laboratories, which developed atrasentan.
Correspondence: Dr. Joel B. Nelson