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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	Myrna Rauckhorst, R.N. Research Nurse Specialist Phone: 301-496-7224 Fax: 301-480-1779 mrauckhorst@mail.nih.gov

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Key Eligibility Criteria:

• Histologically confirmed newly diagnosed high risk prostate cancer
• No metastatic disease evident on CT scan or bone scan
• No previous treatment for prostate cancer
• ≥ 18 years of age
• Able and willing to have androgen deprivation therapy (ADT), radiation therapy, and an MRI
• Able to have a prostate biopsy
• Not immunocompromised; no prior history or clinical evidence of autoimmune disease, immunodeficiency disease, or history of organ transplant
• Adequate organ function as defined by liver, kidney, and hematologic laboratory testing
• No uncontrolled intercurrent illness or psychiatric illness/social situations that would limit compliance with study requirements
• Meets specific tissue (HLA) requirements; likely present in 60% of Americans (testing provided by NCI)

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Study Outline:

• Screening with physical examination, blood samples, and imaging studies to determine eligibility for the study
• Eligible patients will be randomly assigned to receive L-BLP25 with standard care or standard care alone (you or your doctor cannot choose the group to which you are assigned)
• All patients will receive ADT (goserelin subcutaneously every 3 months for 2 years) and radiation therapy lasting 6–8 weeks starting 2 months after ADT
• Only those patients assigned to receive the vaccine
• L-BLP25 injections every 2 weeks for 5 doses (10 weeks) starting with the ADT therapy, followed by L-BLP25 injections every 6 weeks for 4 doses (24 weeks)
• All patients will undergo apheresis (collection of immune cells) and consenting patients will undergo prostate biopsy prior to ADT, prior to starting radiation therapy, and at 6 months after

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

Reviewed: 9/6/12
Updated: 2/15/13