A Phase 2 Study to Determine the Safety and Efficacy of BIND-014 (Docetaxel Nanoparticles for Injectable Suspension), Administered to Patients With Metastatic Castration-Resistant Prostate Cancer

Inclusion Criteria:

* Histologically or cytologically confirmed adenocarcinoma of the prostate
* Metastatic disease progressing despite castrate levels of testosterone
* Prostate cancer progression documented by PSA
* Surgically or medically castrated, with testosterone levels of \< 50 ng/dL
* Previous anti-androgen therapy and progression after withdrawal
* ECOG performance status of 0 to 1
* Adequate organ function
* Prior radiation therapy allowed to \< 25% of the bone marrow
* Prior hormonal therapy is allowed
* Patient compliance and geographic proximity that allow adequate follow-up.
* Patients with reproductive potential must use contraceptive methods
* Signed informed consent from patient

Exclusion Criteria:

* Active infection
* Any chronic medical condition requiring a high doses of corticosteroid
* Pathological finding consistent with small cell carcinoma of the prostate
* Brain metastasis
* Prior cytotoxic chemotherapy or biologic therapy for the treatment of CRPC
* Radiation therapy for treatment of the primary tumor within 6 weeks
* Radionuclide therapy for treatment of metastatic CRPC
* Prior systemic treatment with an azole drug
* Prior flutamide treatment within 4 weeks
* Prior bicalutamide or nilutamide within 6 weeks
* Congenital long QT syndrome, congestive heart failure, or bradyarrhythmia
* Administration of an investigational therapeutic within 2 weeks
* Second primary malignancy
* Presence of clinically detectable third-space fluid collections
* History of severe hypersensitivity reaction to polysorbate 80
* Peripheral neuropathy at study entry