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
Summary
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
Detailed description
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.
Arms & interventions
- BiologicalpTVG-HP DNA vaccine
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.
- DrugAnti-PD-1 monoclonal antibody
Nivolumab is a potent human immunoglobulin G4 (IgG4) monoclonal antibody (mAb). Participants will receive two 10mg doses.
Outcome measures
Primary
PSA (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
Secondary
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
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
Eligibility criteria
Study locations (1)
University of Wisconsin - Madison
Madison, Wisconsin, 53705