Actively Recruiting
Trial of pTVG-HP+Nivo+Targeted Ablation of Resistant Lesions in Non-Castrate RecurrentOMPC
Led by University of Wisconsin, Madison · Updated on 2026-03-11
14
Participants Needed
1
Research Sites
239 weeks
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
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
CONDITIONS
Official 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 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, at least 3 months prior to entry with removal or ablation of all visible disease
- Participants must have biochemically recurrent disease with a positive PSA doubling time based on at least 4 serum PSA values collected up to one year prior to enrollment
- Participants must have oligometastatic disease with fewer than 3 lesions consistent with metastases detected by CT and bone scan or PSMA PET/CT
- Participants with a prior history of second malignancy 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 score less than 2 and life expectancy of at least 12 months
- Participants must have normal hematologic, renal and liver function
- Participants must provide informed consent acknowledging study risks
- Willingness to provide blood samples for immune studies up to one year after study, even if off treatment
You will not qualify if you...
- Small cell or other variant prostate cancer histology
- Evidence of immunosuppression or treatment with immunosuppressive therapy such as chemotherapy or corticosteroids greater than 10 mg prednisone daily within 3 months prior to first vaccination
- Seropositive for HIV, hepatitis B, or hepatitis C
- Prior treatment with LHRH agonist or nonsteroidal antiandrogen except in certain neoadjuvant/adjuvant settings with no PSA progression and limited duration
- Serum testosterone below 50 ng/dL at screening
- Concurrent use of medications or supplements with hormonal effects such as PC-SPES, megestrol acetate, finasteride, ketoconazole, estradiol, or Saw Palmetto
- Previous experimental prostate cancer therapies without at least 4 week washout before treatment start
- Known psychological, sociological, or addictive disorders impacting protocol compliance
- Unstable or severe medical conditions or lab abnormalities that pose excess risk
- Concurrent enrollment in other investigational prostate cancer treatment studies with active treatment or last dose within 4 weeks prior to day 1
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Wisconsin - Madison
Madison, Wisconsin, United States, 53705
Actively Recruiting
Research Team
C
Cancer Connect
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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