Affinity: A Phase III Trial Using Custirsen and Jevtana® for Men with Metastatic Hormone-Resistant Prostate Cancer.
The goal of the Phase III Affinity Trial is to test whether adding an experimental drug called custirsen to Jevtana® (cabazitaxel) chemotherapy can help treat men with hormone-resistant prostate cancer. In the latter case, chemotherapy with taxotere (docetaxel®) or Jevtana® (cabazitaxel) are often the first lines of chemotherapy adminstered. However, they are often accompanied by undesirable side effects and patients may eventually become resistant to the treatments. The current trial will examine whether adding the drug custirsen to the treatment with Jevtana® can help slow the progression of the prostate cancer. Custirsen is an experimental drug designed to block the production of a protein (clusterin) associated with treatment resistance in many cancers. Phase 2 trials suggest that custirsen may improve overall survival for patients with prostate cancer. While Jevtana® has been approved by the Food and Drug Administration, custirsen has not yet been approved. For additional details, see the following link to the Affinity trial as well as the January 3rd, 2012 website blog describing various prostate therapies in differing stages of clinical development.