Is Zytiga with Prednisone Effective in Men with Metastatic Prostate Cancer Who Have Visceral Disease?

Castate resistant metastatic prostate cancer (mRPC) withvisceral disease (tumors involving the internal organs of the body, specifically those within the chest (as the heart or lungs) or abdomen (as the liver, pancreas or intestines) is a negative prognostic factor.

In many cases clinical trials of new investigational drugs rule out men with visceral disease from the trial sample.  This often results in the FDA approved label specifically excluding men with visceral disease.  This makes it very easy for insurance companies to refuse to pay for these drugs in men with visceral disease since this is technically an “off label” use.

There was an exploratory analysis of the COU-AA-301 clinical trial of abiraterone acetate (Zytiga) that assessed whether Zytiga improved overall survival (OS) in mCRPC men with visceral disease in the post chemotherapy (docetaxel) stage of treatment.

In the COU-AA-301trial, men who had failed or stopped chemotherapy (docetaxel) were randomized 2:1 to Zytiga 1000?mg (n=797) or placebo (n=398) once