Pilot Trial of a DNA Vaccine Encoding Prostatic Acid Phosphatase (pTVG-HP) and PD-1 Blockade, With Targeted Ablation of Resistant Lesions, in Patients With Non-Castrate Recurrent Oligometastatic Prostate Cancer
The goal of this clinical trial is to learn whether an experimental vaccine called pTVG-HP (vaccine or DNA vaccine), combined with a drug called nivolumab can increase the cancer-fighting ability of a person's immune cells. The main question it aims to answer is whether the combination of medicines can get rid of metastatic tumors in participants with non-castrate, recurrent, oligometastatic prostate cancer. Participants will undergo: * Treatment with pTVG-HP * Treatment with Nivolumab * Radiation Therapy
• Participants must be at least 18 years of age with a histologic diagnosis of adenocarcinoma of the prostate
• Participants must have undergone radical prostatectomy
• Participants must have completed local therapy by surgery, and any adjuvant/salvage radiation therapy (if required), at least 3 months prior to entry, with removal or ablation of all visible disease, including seminal vesical and/or local lymph node involvement.
• Participants must have biochemically recurrent disease defined by the following:
‣ PSA doubling time, calculated from most recent 4 serum PSA values (collected up to one year prior to enrollment, at least 2 weeks apart, and all from the same clinical laboratory), must be a positive number (i.e. evidence of PSA rise over time).
• Participants must have oligometastatic disease, defined as:
‣ \< 3 lesions consistent with metastases as detected by CT of the abdomen/pelvis and bone scintigraphy (bone scan)
⁃ Lesions consistent with metastatic prostate cancer as detected by PSMA PET/CT
• Participants with a prior history of a second malignancy are eligible provided they have been treated with curative intent and have been free of disease greater than three years. There will be no exclusion for patients with a history of basal cell carcinoma, squamous cell skin cancer, superficial bladder cancer, or other in situ carcinoma that has been adequately treated.
• Participants who are sexually active must use a reliable form of contraception while on study and for 4 weeks after the last immunization.
• ECOG performance score \< 2 and life expectancy of at least 12 months.
• Participants must have normal hematologic, renal and liver function
• Participants must be informed of the experimental nature of the study and its potential risks and must sign an IRB-approved written informed consent form indicating such an understanding.
• Willingness to provide blood samples for immune studies, per study calendar, up to one year after study, even if off treatment.