The Safety and Tolerability of PGV001-based Personalized Multi-peptide Vaccines in the Adjuvant Setting.

Inclusion Criteria

• •To be enrolled a subject must meet the following criteria:
• •The subject must have a histologically proven diagnosis of adenocarcinoma of prostate
• •The subject should have any one of:
• •1. PSA persistence post surgery (defined as a PSA value that fails to become undetectable) by six weeks post treatment,
• •2. Biochemical recurrence (defined as a PSA value ≥ 0.2ng/ml),
• •3. An elevated PSA with a doubling time of \> 3 months,
• •4. Or an estimated risk of biochemical recurrence within 5 years of 30% or more as assessed by decipher™ report (decipher score of ≥0.3).
• •At the time of treatment, the subjects must have completed radical prostatectomy (rp), all additional s.o.c therapies and be clinically tumor free as defined by s.o.c imaging studies
• •Written informed consent obtained prior to any study procedure.
• •The subject must be able to provide the necessary tissue sample for sequencing, either by surgical resection or open-surgical or core biopsy sampling of the primary tumor
• •This requirement may be satisfied by providing an archival tissue sample that has been stored in rna later, flash-frozen, or under other rna/dna preserving conditions from an earlier resection.
• •This requirement may also be satisfied by providing rna/dna sequencing from a CLIA certified genomic sequencing laboratory.
• •Before administration of the investigational product, the following time must have elapsed:
• •1. At least (4) weeks post general anesthesia
• •2. At least seventy-two (72) hours post local/epidural anesthesia
• •3. The subject must complete all prior systemic chemotherapy therapy, and all adverse events have either returned to baseline or have stabilized at least four (4) weeks prior to administration of the investigational product.
• •4. The subject must complete all prior systemic radiation therapy at least four (4) weeks prior to administration of the investigational product. The subject must not have received a radiopharmaceutical within eight (8) weeks prior to the administration of the investigational product.
• •5. The subject may continue hormonal therapy (e.g. Anti-androgens) during the study.
• •6. Subjects may have a detectable or rising PSA provided there is no radiographic evidence of metastatic disease. For patients with a rising PSA, the doubling time should be \>3 months.
• •9\. The subject must have a life expectancy greater than twelve (12) months at the time of screening as assessed by the treating physician.
• •The subject must have a performance status of 0-1 as determined by criteria set forward by the eastern cooperative oncology group243.
• •The subject must have at the time of screening acceptable hematologic, hepatic, and renal function, defined by the following:
• •1. Absolute neutrophil count \> 1000/mm3
• •2. Platelet count \> 50,000/mm3,
• •3. Creatinine \< 2.5 mg/dl,
• •4. Total bilirubin ≤ 1.5 mg/dl, (except in patients with gilbert syndrome who can have total bilirubin \< 3.0 mg/dl)
• •5. Transaminases \< 2 times above the upper limits of the institutional normal.
• •6. INR\<2 if off of anticoagulation. Patients on anticoagulation therapy with an INR\>2 may be enrolled at the discretion of the investigator if they have not had any episodes of severe hemorrhage.
• •Adequate venous access (for leukapheresis and blood draws)
• •The subject must be male 18 years of age or older.
• •The subject must be deemed competent to give informed consent.
• •The subject must agree to use a condom and another effective method of birth control if he is having sex with a woman of childbearing potential or agrees to use a condom if he is having sex with a woman who is pregnant.