Actively Recruiting
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
Led by University of Wisconsin, Madison · Updated on 2026-03-11
14
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
U
University of Wisconsin, Madison
Lead Sponsor
U
United States Department of Defense
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying whether combining an experimental DNA vaccine called pTVG-HP with the drug nivolumab can boost the immune system's ability to fight metastatic tumors in men with non-castrate, recurrent, oligometastatic prostate cancer. This pilot phase 1 trial explores if this combination, along with targeted ablation of resistant lesions, can eliminate tumor sites. Participants will receive injections of the pTVG-HP vaccine into the arm and two doses of nivolumab, a monoclonal antibody, as part of the treatment. Alongside these medicines, targeted radiation therapy will be used to destroy resistant cancer lesions. This combined approach aims to attack the cancer through multiple methods. During the study, participants will undergo regular monitoring including prostate-specific antigen (PSA) testing over several years to assess response and progression. Researchers will track any side effects, toxicity, and survival outcomes. Blood samples will be collected for immune studies up to one year after treatment, and participants will be followed for up to five years to measure long-term effects and cancer control.
CONDITIONS
Brief Title
Trial of pTVG-HP+Nivo+Targeted Ablation of Resistant Lesions in Non-Castrate RecurrentOMPC
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be at least 18 years old with a diagnosis of adenocarcinoma of the prostate
- Participants must have undergone radical prostatectomy
- Participants must have completed local surgery and any required radiation therapy at least 3 months before joining
- Participants must have biochemically recurrent disease with a positive PSA doubling time based on recent PSA tests
- Participants must have fewer than 3 metastatic lesions detected by CT, bone scan, or PSMA PET/CT
- Participants with a prior second cancer are eligible if treated with curative intent and disease-free for over 3 years
- Sexually active participants must use reliable contraception during the study and for 4 weeks after last immunization
- ECOG performance status less than 2 and life expectancy of at least 12 months
- Participants must have normal blood, kidney, and liver function
- Participants must understand the experimental nature and sign informed consent
- Willingness to provide blood samples for immune studies up to one year after treatment
You will not qualify if you...
- Small cell or other variant prostate cancer histology
- Evidence of immunosuppression or recent immunosuppressive therapy including chemotherapy or high-dose corticosteroids within 3 months
- Positive for HIV, hepatitis B, or hepatitis C
- Prior androgen deprivation therapy beyond allowed neoadjuvant/adjuvant use with no PSA progression and less than 24 months
- Serum testosterone below 50 ng/dL at screening
- Use of medications or supplements with hormonal effects like PC-SPES, megestrol acetate, finasteride, ketoconazole, estradiol, or Saw Palmetto
- Recent use of experimental prostate cancer therapies without at least 4 weeks washout
- Psychological, social, or addictive conditions that would prevent protocol compliance
- Severe or unstable medical conditions posing excess risk
- Current enrollment in other investigational prostate cancer treatment studies with recent treatment within 4 weeks
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 12 months
Participants receive a DNA vaccine (pTVG-HP) and two doses of nivolumab, combined with targeted ablation of resistant lesions, to treat non-castrate recurrent oligometastatic prostate cancer.
Multiple visits during treatment for vaccine administration, nivolumab doses, and targeted ablation procedures
Duration - Up to 5 years
Participants are monitored for treatment response, adverse events, and long-term outcomes including survival and PSA measurements.
Periodic visits for follow-up assessments and blood sample collections up to one year after treatment
Trial Site Locations
Total: 1 location
1
University of Wisconsin - Madison
Madison, Wisconsin, United States, 53705
Actively Recruiting
Research Team
C
Cancer Connect
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here