Amendments planned for prostate cancer immunotherapy trial

Dendreon Corp. has reached an agreement with the FDA under the Special Protocol Assessment procedure to amend the design of its ongoing phase III (D9902B) clinical trial of sipuleucel-T (Provenge), the company’s investigational active cellular immunotherapy for the treatment of advanced prostate cancer.

The trial was initiated in June for the treatment of men with asymptomatic, metastatic, androgen-independent prostate cancer whose tumors had been classified with a Gleason score of 7 or lower. The amended D9902B protocol will now be known as the IMPACT (Immunotherapy for Prostate AdenoCarcinoma Treatment) study. Key amendments include the following:

• Patients will be eligible to enroll in the study, regardless of Gleason score.

• Patients with minimally symptomatic, disease-related pain will be eligible for the study.

• The primary endpoint of the study is now overall survival, and the secondary endpoint is time to objective disease progression.

• The trial is designed to enroll approximately 500 men.

• The primary statistical analysis to determine efficacy will be the Cox multivariate regression model.

Look for more details on results of the D9902B trial in the January 2006 issue of Urology Times.