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
To explore the use of an investigational DNA vaccine, pTVG-HP, a plasmid DNA encoding human prostatic acid phosphatase (PAP), in combination with nivolumab delivered with vaccination, and in combination with targeted ablation of treatment-resistant lesions, to eradicate metastatic tumor lesions in patients with non-castrate, recurrent, oligometastatic prostate cancer.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
14
The vaccine will be injected into the outer side of the upper area of the arm in two adjacent sites, with 0.25 mL administered at each site.
Nivolumab is a potent human immunoglobulin G4 (IgG4) monoclonal antibody (mAb). Participants will receive two 10mg doses.
University of Wisconsin - Madison
Madison, Wisconsin, United States
RECRUITINGPSA (prostate-specific antigen) complete response rate
Defined as a serum PSA \<0.2 ng/mL at 1 year after prostatectomy
Time frame: 12 months
Incidence of Adverse Events
Adverse events will be evaluated using the most recent version of the Common Terminology Criteria for Adverse Events (CTCAE).
Time frame: 5 years
Toxicity Rates
Toxicity rates (grade 2, grade 3, grade 4, grade ≥ 2, grade ≥ 3, etc.) will be calculated for each study arm and reported along the corresponding 95% confidence intervals. The 95% confidence intervals will be constructed using the Wilson score method.
Time frame: 5 years
Metastasis-free survival rate at 1 year
Time frame: 12 months
Metastasis-free survival rate at 2 years
Time frame: 2 years
Progression-free survival (PSA) at 5 years
Defined as a serum PSA \<0.2 ng/mL at 5 years after prostatectomy, in patients with non-castrate (\>25 ng/dL) testosterone levels.
Time frame: 5 years
Change in PSA doubling time
Time frame: Baseline to 5 years
Change in PSA slope
Time frame: Baseline to 5 years
Overall PSA response rate
Time frame: Up to 5 years
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