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Investigator(s):
Ravi A. Madan, M.D. Principal Investigator Phone: 301-496-3493 Fax: 301-480-5094 madanr@mail.nih.gov
Referral Contact(s):
Laura D. Otten, R.N., B.S.N., O.C.N. Medical Oncology Referral Coordinator Phone: 301-451-1228 1-866-611-6310 (Toll Free) Fax: 301-480-0919 ottenl@mail.nih.gov	Sheri McMahon Research Nurse Specialist Phone: 301-496-9812 Fax: 301-480-1779 sheri.mcmahon@nih.gov

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Key Eligibility Criteria:

• Histopathological documentation of prostate cancer confirmed in the NIH Laboratory of Pathology
• Must have non-metastatic castration-resistant prostate cancer:
• Rising PSA with castrate levels of testosterone and no evidence of metastatic disease on CT scan or bone scan (rising PSA is defined as two consecutively rising PSA levels, separated by ≥ 1 month apart, with the last measurement > 1 ng/mL)
• Patients must recover from prior therapy and show evidence of rising PSA
• No history of a rising PSA on flutamide
• Patients who have received prior flutamide therapy for > 1 month (prior to enrolling on study) are not eligible
• Life expectancy ≥ 6 months
• ECOG performance status of 0–1
• Granulocyte count ≥ 1,500/mm³; platelet count ≥ 100,000/mm³; hemoglobin ≥ 9 g/dL; lymphocyte count ≥ 500/mm³; bilirubin < 1.5 mg/dl; AST and ALT < 2.5 x upper limit of normal (ULN)
• Patients must have < grade 2 proteinuria (unless the cause is determined not to be renal)
• Creatinine clearance ≥ 60 mL/min with 24-hour urine collection
• HIV negative, hepatitis B and C negative
• No other active malignancies within the past 3 years (with the exception of non-melanoma skin cancers or carcinoma in situ of the bladder) or life-threatening illnesses
• Recovered from all prior therapy
• No autoimmune diseases
• No serious intercurrent medical illness that would preclude study participation
• No history of heart disease; no history of pulmonary disease
• No CNS involvement or history of seizures, encephalitis, or multiple sclerosis
• Patients with prior splenectomy are not eligible
• No hypersensitivity to egg products

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Study Outline:

Patients will be randomized on a 1:1 basis to Arm I (flutamide alone) or Arm II (flutamide + vaccine).

Arm I

• Patients receive flutamide 250 mg orally 3 x daily (TID) beginning on Day 1

Arm II

• Flutamide 250 mg orally TID beginning on Day 1
• PROSTVAC-V/TRICOM (vaccinia) subcutaneously on Day 1 of the first cycle only
• Followed by monthly (every 4 weeks) boosting vaccinations with PROSTVAC-F/TRICOM (fowlpox) subcutaneously on Day 1 of each cycle
• Sargramostim 100 mcg subcutaneously will be given at the vaccine site for 4 consecutive days starting on Day 1 of each vaccine cycle
• Treatment repeats every 28 days

After 3 months of therapy, patients receiving the flutamide alone (Arm I) may cross over to receive vaccine if they develop a rising PSA and scans are without metastatic disease.

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, and study outline.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 9/6/12
Updated: 10/18/12