Feasibility, Safety and Efficacy Evaluation of Alpha-Type 1 Dendritic Cell(DC)-Based Vaccines Loaded With Allogeneic Prostate Cell Lines in Combination With Androgen Ablation in Patients With PSA Progression After Local Therapy for Prostate Cancer

Inclusion Criteria:

- Patients with histologically proven prostate cancer and tumors limited to the
prostate (including seminal vesicle involvement, provided all visible disease was
surgically removed) that have completed local therapy and have an elevated PSA after
surgery or rising PSA after radiation therapy, as defined below.

- Age > 18 years.

- Histologically confirmed diagnosis of prostate cancer.

- Previous treatment with definitive surgery or radiation therapy or both.

- No evidence of metastatic disease on physical exam, CT/MRI/CXR (see section 7.1 for
radiologic imaging), and bone scan within 4 weeks prior to randomization.

- Prior neoadjuvant/adjuvant hormonal or chemotherapy is allowed if it was last used >
12 months prior to enrollment.

- No therapy modulating testosterone levels (such as leuteinizing-hormone
releasing-hormone agonists/antagonists and antiandrogens) is permitted within 12
months prior to enrollment. Agents such as 5α-reductase inhibitors, ketoconazole,
megestrol acetate, systemic steroids (replacement doses of steroids are allowed),
PC-SPES, Saw Palmetto are not permitted at any time during the period that the PSA
values are being collected.

- Hormone-sensitive prostate cancer as evident by a serum total testosterone level >
150 ng/dL or >6 nmol/L at the time of enrollment within 4 weeks prior to
randomization.

- No other signs of clinical recurrence or dissemination of prostate cancer as defined
by normal CT-scan or MRI of the pelvis without local recurrence, and bone scan
negative for metastases, and chest X-ray negative for metastases. Prostascint scans
will not be used to assess disease prior to study entry.

- No concomitant therapy with steroids (replacement doses of steroids are allowed.

- All patients must have evidence of biochemical progression as determined by a
reference PSA value followed by 1 confirmatory rising PSA value, higher than the
previous value, obtained at least 2 weeks apart. All of these PSA values must be
obtained at the same reference lab, and all must be done within 6 months prior to
enrollment.

- The most recent of the PSA values must be > 2.0 ng/ml. This measurement must be
obtained within 1 month prior to enrollment.

- The PSA doubling time (PSA-DT) must be less than 12 months.

- ECOG performance status 0 or 1.

- Patients must have normal organ and marrow function as defined below:

- Absolute neutrophil count >1,500/ul

- Platelets >100,000/ul

- Total bilirubin 1.5 x upper limit of normal (ULN)

- SGOT (AST) and SGPT (ALT) < 2.5 x institutional ULN

- Creatinine 1.5 x ULN

- The effects of dendritic cell vaccines on the developing human fetus are unknown. For
this reason men must agree to use adequate contraception (hormonal or barrier method
of birth control) prior to study entry and for the duration of study participation.

Exclusion Criteria:

- Patients must not be receiving other investigational agents or concurrent anticancer
therapy.

- No uncontrolled intercurrent illness including, but not limited to, ongoing or active
infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac
arrhythmia, or psychiatric illness/social situations that would limit compliance with
study requirements.

- Patients must not have active eczema, atopic dermatitis, or other exfoliative skin
conditions (e.g., burns, impetigo, varicella zoster, severe acne, contact dermatitis,
psoriasis, herpes or other open rashes or wounds).

- Presence of an active acute or chronic infection, including urinary tract infection,
HIV or viral hepatitis HIV patients are excluded based on immunosuppression which may
render them unable to respond to the vaccine; patients with chronic hepatitis are
excluded because of concern that hepatitis could be exacerbated by the injections. If
clinically indicate HIV/viral hepatitis testing will be performed to confirm status.

- Patients with a history of auto-immune disease such as, but not restricted to,
inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis,
scleroderma, or multiple sclerosis. Patients receiving replacement thyroid hormone
would be eligible.

- No concurrent use of systemic steroids, except for local (topical, nasal, or inhaled)
steroid use (replacement doses of steroids allowed).

- Subjects with concurrent additional malignancy (with exception of non-melanoma skin
cancers and superficial bladder cancer or malignancy within last 3 years).