Inclusion Criteria:

- History of histologically confirmed prostate cancer.

- Competence to understand the patient information and provide written informed
consent, and willingness and ability to return to H. Lee Moffitt Cancer Center for
planned treatments and follow-up.

- Absence of evidence of metastatic disease by current physical exam or by current
imaging studies (computed tomography [CT] or magnetic resonance imaging [MRI] pelvis,
and bone scan within 60 days of first treatment).

- Patients not on hormone therapy (stratum "N") must meet all of these:

1. At least 1 year after prostatectomy, definitive prostate radiation, or other
definitive-intent local therapy.

2. No testosterone suppression therapy for at least 6 months.

3. PSA at least 1 ng/ml, on 2 measurements, at least 2 weeks apart.

4. Testosterone level >100 ng/ml, at start ("noncastrate").

- Patients on hormone therapy (stratum "Y") must meet all of these:

1. On treatment with gonadotropin-releasing hormone (GnRH) agonist (or orchiectomy)
at least 6 months.

2. testosterone level <50 ng/ml, at start.

3. PSA at least 1 ng/ml, on 2 measurements, at least 2 weeks apart.

- Laboratory values obtained 0-14 days prior to start of therapy:

1. White blood count (WBC) over 3,500/micro L.

2. Platelet count over 100,000 micro L.

3. Hemoglobin over 10.0 g/dL.

4. Serum creatinine up to 2.0 mg/dL.

5. Alkaline phosphatase up to 2.5 x upper limit of normal (ULN).

6. Aspartic transaminase (AST) up to 2.5 x ULN.

- Life expectancy at least 6 months.

- Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0 or 1.

Exclusion Criteria:

- Known standard therapy for the patient's disease that is potentially curative.

- A known immunodeficiency including HIV. Appropriate trials for individuals with HIV
may be considered at a later date.

- History of other malignancy besides prostate cancer in the last 5 years, except
non-melanoma skin cancer treated with local resection only. (The effect of study
treatment on other, potentially dormant malignant diseases is not known).

- Use of oral or inhaled or parenteral corticosteroids or of other immunomodulatory
drugs within the 60 days of start. [Use of steroids after start will be considered by
the principal investigator (PI) on a case-by-case basis.]

- Use of estrogens (including herbal phytoestrogens) or ketoconazole within 30 days of
start, or during the study.

- Failure to fully recover to grade 1 or better from effects of prior chemotherapy
regardless of interval since last treatment.

- Other concurrent chemotherapy, immunotherapy, radiotherapy, or investigational agent
in last 30 days (one month washout to start of treatment; patients could register but
not start until the washout).

- Known hypersensitivity to one or more components of the study medication.

- 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.