Trial of pTVG-HP+Nivo+Targeted Ablation of Resistant Lesions in Non-Castrate RecurrentOMPC

Exclusion Criteria10

• Small cell or other variant prostate cancer histology
• Participants cannot have evidence of immunosuppression or have been treated with immunosuppressive therapy, such as chemotherapy or chronic treatment dose corticosteroids (greater than the equivalent of 10 mg prednisone per day), within 3 months of the first vaccination.
• Seropositive for HIV, hepatitis B (HBV) or hepatitis C (HCV) per patient history due to the immunosuppressive features of these diseases.
• Prior treatment with an LHRH agonist or nonsteroidal antiandrogen, except in the following circumstances: Neoadjuvant/adjuvant androgen deprivation therapy administered with radiation therapy or at the time of prostatectomy is acceptable, provided that there was no evidence of PSA progression while on treatment. In this situation, patients must not have received more than 24 months of androgen deprivation treatment. Other treatment with androgen deprivation therapy is prohibited.
• Serum testosterone at screening \< 50 ng/dL.
• Participants must not be concurrently taking other medications or supplements with known hormonal effects, including PC-SPES, megestrol acetate, finasteride, ketoconazole, estradiol, or Saw Palmetto. All other medications with possible anti-cancer effects must be discussed with the PI prior to study entry.
• Participants previously treated with other potential or experimental therapies for prostate cancer must have discontinued these treatments and completed at least a 4 week washout prior to beginning treatment.
• Participants must not have known psychological or sociological conditions, addictive disorders or family problems, which would preclude compliance with the protocol.
• Participants with unstable or severe intercurrent medical conditions or laboratory abnormalities that would impart, in the judgment of the PI, excess risk associated with study participation or study agent administration.
• Participants who have concurrent enrollment on other phase I, II, or III investigational therapeutic treatment studies for prostate cancer cannot be actively receiving treatment and the last dose cannot be within 4 weeks of day 1. They must be in the follow up phase of the study.