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Investigator(s):
James L. Gulley, M.D., Ph.D., F.A.C.P. Principal Investigator Phone: 301-435-2956 gulleyj@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	Mary Pazdur, C.R.N.P. Nurse Practitioner Phone: 301-496-7870 Fax: 301-480-5094 pazdurm@mail.nih.gov

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Primary Eligibility:

• Histologically confirmed prostate cancer with biochemical progression as follows:
  • A rise in PSA of ≥ 2 ng/mL above the nadir for patients previously treated with definitive radiotherapy or cryotherapy
  • Two consecutive rises in PSA > 0.3 ng/mL for patients previously treated with radical prostatectomy
• PSA ≤ 20 ng/mL
• Testosterone ≥ 212 ng/dL
• Negative CT scan and bone scan for metastatic disease
• No active brain metastases
• Recovered from prior treatment
• No prior chemotherapy
• No concurrent topical steroids or systemic steroids; nasal or inhaled steroid use is permitted
• No drugs known to affect PSA (e.g., finasteride, dutasteride and saw palmetto)
• No other concurrent anticancer treatment or hormonal therapy
• ECOG 0–1
• Granulocyte count ≥ 1,500/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 10 g/dL
• Bilirubin < 1.5 mg/dL (OR ≤ 3 mg/dL in patients with Gilbert’s syndrome)
• AST and ALT < 2.5 x upper limit of normal (ULN)
• No life-threatening illnesses or other active malignancies (with exception of nonmelanoma skin cancers or carcinoma in situ of bladder) within the past 5 years
• No evidence of being immunocompromised (HIV positivity and/or active autoimmune disease)
• No other serious medical illnesses that would preclude study participation

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Treatment Plan:

This is a double-blinded study, meaning that neither the patient nor the clinical research team knows what type of vaccine the patient is receiving. Patients are stratified according to PSA doubling time (< 12 months vs. ≥ 12 months).

• Patients receive goserelin subcutaneously once
• After approximately 3 months, patients are randomized to one of two treatment arms:
  
  
  Arm I:
  
  
  • Patients receive ONY-P1 vaccine with BCG intradermally on Days 1 and 15
  • Patients receive ONY-P1 vaccine alone on Day 29 and then every 4 weeks for up to 12 months (up to a total of 14 vaccinations) in the absence of disease progression or unacceptable toxicity
  
  
  Arm II:
  
  
  • Patients will receive placebo injection on Days 1, 15, and 29, and then once a month for up to 12 months
  
  
• After completion of study therapy, patients are followed periodically for up to 15 years

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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, treatment plan.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 5/30/08
Updated: 12/10/08