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

This is an interventional treatment trial for Prostate Cancer focused on measuring vaccine, PSMA, TARP, immunology, PSA Read More

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.