A Study Evaluating Vaccination of Prostate Cancer Patients With Self Dendritic Cells Expressing MUC1

Inclusion Criteria:

* Subject has a histologically documented diagnosis of prostate cancer
* Subject was surgically castrated at least 3 months prior to study inclusion or has been pharmacologically castrated for a minimum of 3 months prior to study inclusion.
* Subject must meet one of the following PSA criteria:

  * A PSA value of ≥20ng/mL (µg/L) obtained 12 months prior to study inclusion OR
  * A 50% rise in PSA values with a minimum rise of 1.0 ng/ml (µg/L), within 6 months prior to study inclusion OR
  * A rise in PSA defined by 2 sequential increases in PSA values. inclusion. There must be at least 2 weeks between each qualifying PSA value.
* Subjects who have received anti-androgen therapy must have a documented withdrawal period prior to study inclusion.
* For a subject who has withdrawn from anti-androgen therapy LESS than 6 months prior to study inclusion, one of the following criteria is ALSO required for eligibility:

  * Following the completion of the anti-androgen withdrawal period, one post-withdrawal PSA value must be higher than the last pre-withdrawal PSA value OR
  * Following the completion of the anti-androgen withdrawal period, if the subject's PSA value decreased, then he can still qualify if two increases in PSA values (as described in 4c) are documented after post-withdrawal nadir.
* At the time of screening the subject has no distant metastatic disease.

Exclusion Criteria:

* Subject is less than 19 years of age.
* Subject has a PSA value \< 1.0 ng/mL at screening
* Subject currently has evidence of distant metastases.
* Subject has not, in the opinion of the investigator, a life expectancy greater than 12 months.
* Subject has a local recurrence and is a candidate for local salvage therapy
* Subject having previously received therapy \[including radiation, steroids, radionuclides (such as rhenium, strontium or samarium), cryotherapy or cytotoxic chemotherapy\] for prostate cancer are ineligible as defined below:

  * Subjects who received previous cytotoxic chemotherapy or radionuclide therapies are ineligible
  * Subjects who received therapy to the prostatic bed (external beam radiotherapy, brachytherapy or cryotherapy) within 6 months prior to study entry are ineligible.
  * Subjects who received radiation therapy to any lesion outside the prostate bed more than 6 months after castration or hormone initiation are ineligible.
  * Subjects who received steroids for the treatment of prostate cancer within 6 months prior to study entry are ineligible.
* Subjects having previously received opioid analgesic therapy.
* Subjects has received any of the following within 4 weeks of study entry:

  * Cyproterone acetate, ketoconazole, PC-SPES or other hormonally active therapies (with the exception of GnRH agonists or antagonists).
  * An investigational product
* Subject is on a concurrent steroids or immunosuppressive therapy for chronic inflammatory disease.
* Subject has had other malignancies within the previous 5 years with the exception of non-melanoma skin cancer.
* Subject has a score \>1 on the ECOG Performance Scale (see Appendix I)
* Subject has an inadequate hematologic function
* Subject has inadequate liver function.
* Subject has a creatinine clearance \<40 mL/min
* Subject has a known history of cardiovascular disability status of New York Heart Association Class ≥2.
* Subject has a history of uncontrolled asthma
* Subject has autoimmune disease(s)
* Subject has active infection(s)
* Subject is receiving antiretroviral therapy.
* Subject has received blood transfusion within 8 weeks of study inclusion.
* Subject has a clinically significant, unstable, uncontrolled disease that could be adversely affected by study participation.
* Subject has known allergy to shellfish