PSMA and TARP Peptide Vaccine With Poly IC-LC Adjuvant in HLA-A2 (+) Patients With Elevated PSA After Initial Definitive Treatment

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.