DSMB

The primary objective of this study is:

• To evaluate the effect of DN-101 in combination with docetaxel (ASCENT regimen) on survival in metastatic androgen-independent prostate cancer

The secondary objectives of this study are:

• To determine the effect of the ASCENT regimen on the rate of thromboembolic events (blood clots)
• To determine the effect of the ASCENT regimen on prevention of skeletal-related events (fractures)
• A Separate sub-study will be conducted at selected study sites in North America to determine the population PK of DN-101.

Inclusion Criteria:

• Histopathologically or cytologically proven adenocarcinoma of the prostate
• Documented metastatic prostate adenocarcinoma
• Documented progression while on androgen ablation therapy detected by rising prostate specific antigen (PSA) and/or imaging
• Age >= 18 years
• Eastern Cooperative Oncology Group (ECOG) performance status <= 2
• Adequate hematologic, renal and hepatic function
• Life expectancy >= 3 months

Exclusion Criteria:

• Prior chemotherapy, except estramustine
• Prior chemotherapy with docetaxel
• Prior isotope therapy (e.g., strontium-89, samarium-153, etc.)
• One or more contraindications to the use of corticosteroids
• History of cancer-related hypercalcemia