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Reviewer: Dr Lori Wood Date posted: June 21, 2007

Results of a phase III randomized controlled trial of the safety and efficiency of atrasentan in men with nonmetastatic hormone-refractory prostate cancer (HRPC) Authors: Nelson et al, ASCO 2007. Abstract: 5018. Reviewer: Dr Lori Wood Date posted: June 21, 2007. Treatment A:

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Reviewer: Dr Lori Wood Date posted: June 21, 2007

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  1. Results of a phase III randomized controlled trial of the safety and efficiency of atrasentan in men with nonmetastatic hormone-refractory prostate cancer (HRPC)Authors: Nelson et al, ASCO 2007.Abstract: 5018 Reviewer: Dr Lori Wood Date posted: June 21, 2007

  2. Treatment A: Atrasentan 10 mg p.o. qd Hormone refractory prostate cancer -non-metastatic -rising PSA (n=941) R Treatment B: Placebo

  3. RESULTS Primary endpoint = time to disease progression (development of metastases).

  4. STUDY COMMENTARY • This was a phase III study to determine if Atrasentan (a potent, selective oral endothelin A receptor antagonist) could decrease the time to disease progression and thus improve progression free survival primarily by decreasing the onset of skeletal metastases. • This study failed to show a benefit in terms of delaying disease progression or improving overall survival. • There was an open label extension study after study closure which may or may not have influenced overall survival (54% crossed over). • A large number of patients in both arms discontinued therapy (26-33%) especially patients in the US which may or may not have influenced the outcome.

  5. BOTTOM LINE FOR CANADIAN MEDICAL ONCOLOGISTS • Based on this study, Atrasentan should not be considered a standard of care in the patient population. • There is an ongoing phase III trial (SWOG 0421) randomizing metastatic HRPC patients to Docetaxel and Atrasentan vs Docetaxel alone.

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