Trial to Evaluate Safety and Immunogenicity of INO-5150 Alone or With INO-9012 in Men With Prostate Cancer

Inclusion Criteria

• •1. Men aged 18 to 90 years with a histologic diagnosis of prostate cancer;
• •2. c. Biochemical recurrence following local therapy, either surgery or radiation. Rising PSA defined as:
• •* After definitive surgery, e.g.
• •* After radical prostatectomy, two PSA measurements of ≥ 1.0 ng/mL at least one week apart;
• •* After cryosurgery, two PSA measurements of ≥ 2.0 ng/mL at least one week apart;
• •* Other definitive surgical procedures may be permissible upon the approval of the medical monitor OR
• •* After radiation therapy (e.g., external beam radiation, brachytherapy, or salvage/adjuvant radiation therapy after surgery), two post radiation PSA measurements level of nadir plus 2.0 ng/mL at least one week apart.;
• •3. Serum testosterone level:
• •i) Subjects with no history of androgen deprivation therapy:
• •* A single measurement greater than 150 ng/dL or 5.2 nmol/L within 3 months of enrollment
• •ii) Subjects with a history of androgen deprivation therapy (either in adjuvant or biochemical relapse setting):
• •* The two most recent measurements of serum testosterone prior to enrollment must fulfill the following criteria:
• •* Both measurements are greater than 150 ng/dL or 5.2 nmol/L;
• •* The two measurements are spaced at least 14 days apart;
• •* Both must be measured within 3 months of enrollment;
• •4. Normal electro cardio gram (ECG) or ECG with no clinically significant findings;
• •5. Adequate bone marrow, hepatic, and renal function tests within 30 days prior to enrollment:
• •* CBC (except platelets and hemoglobin), serum chemistry, liver panel, and CPK values ≤ Grade 1 abnormality as defined in CTCAE v 4.03 dated June 14, 2010
• •* Platelets ≥ 75,000 /mL;
• •* Hemoglobin ≥ 9.0 g/dL;
• •6. No desire or plans to father new children during the study and/or have a prior vasectomy