Study on pTVG-HP and Nivolumab for Patients with Non-Metastatic Prostate Cancer

Inclusion Criteria

• Must be 18 years or older with a confirmed diagnosis of prostate cancer.
• Must have had surgery to remove the prostate and completed any additional local treatments at least 3 months ago.
• Must have a rising PSA level, with at least 4 PSA tests showing an increase over time, and a final PSA level above 2.0 ng/mL.
• Must not have any signs of cancer spread as shown by CT and bone scans.
• Must be in good overall health with normal blood, kidney, and liver function.
• Must agree to use contraception if sexually active during the study and for 4 weeks after the last vaccine dose.
• Must be willing to provide blood samples for research purposes.
• Must understand the study is experimental and sign a consent form agreeing to participate.

Exclusion Criteria

• Cannot have a type of prostate cancer other than adenocarcinoma.
• Cannot have a weakened immune system or have used immunosuppressive drugs recently.
• Cannot have HIV, hepatitis B, or hepatitis C.
• Cannot have used certain hormone therapies for prostate cancer, except in specific past situations.
• Cannot have a testosterone level below 50 ng/dL at screening.
• Cannot be taking medications or supplements that affect hormones.
• Cannot have had a previous DNA vaccine for prostate cancer.
• Cannot have psychological or social issues that would prevent following the study plan.
• Cannot have allergies to GM-CSF or severe medical conditions that increase risk.
• Cannot be part of another clinical trial for prostate cancer treatment.