An Open-Label, Phase 2 Efficacy Trial of the Implantation of Mouse Renal Adenocarcinoma Cell-Containing Agarose- Agarose Macrobeads in the Treatment of Patients With Castration-Resistant Prostate Cancer Resistant to Docetaxel

Inclusion Criteria:

- Cancer of prostate

- Evidence of metastasis

- Failed available therapies

- Resolution of any toxic effects of previous therapies

- Performance status (ECOG PS) 0-2

- Adequate hematologic, coagulation (INR 2-3max), hepatic and renal function

- Life expectancy of 12 months

- Agrees to contraceptive use while on study if sexually active

- Sign informed consent document

Exclusion Criteria:

- Any condition presenting an unacceptably high anesthetic or surgical risk

- HIV positive

- Cognitive impairment such as to preclude informed consent

- Other surgical treatment, chemotherapy and radiation within four weeks of baseline

- Inadequate hematologic, coagulation (INR >3), hepatic, renal function

- Hepatic blood flow abnormalities and/or large-volume ascites

- Concurrent cancer of any other type except skin cancer (excluding melanoma)

- History of allergic reactions to mouse antigens

- Active infection, congestive heart failure, unstable angina, serious cardiac
arrhythmias, psychiatric illness, difficult social situations not permitting reliable
participation, active bleeding