RecruitingPhase 1NCT07090148

Trial of pTVG-HP+Nivo+Targeted Ablation of Resistant Lesions in Non-Castrate RecurrentOMPC

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

Sponsor

University of Wisconsin, Madison

Enrollment

14 participants

Start Date

Mar 3, 2026

Study Type

INTERVENTIONAL

Conditions

Prostate Cancer Patients Recurrent Prostate Cancer Oligometastatic Prostate Cancer (OMPC)Non-castrate 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

Eligibility

Sex: MALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study combines a prostate cancer vaccine (pTVG-HP) with nivolumab (an immunotherapy drug) and targeted radiation to sites of resistant cancer for men with prostate cancer that has returned after surgery, even though they are not yet on hormone therapy (non-castrate). The goal is to boost the immune system's ability to fight returning cancer. **You may be eligible if...** - You are 18 or older with a confirmed prostate cancer diagnosis - You have had a radical prostatectomy (surgical removal of the prostate) - Your PSA (a prostate cancer marker) is rising after surgery and/or radiation - You have not yet started continuous hormone therapy (androgen deprivation therapy) - Your disease is visible on imaging (oligometastatic) **You may NOT be eligible if...** - You have active autoimmune disease - You have had prior immunotherapy for prostate cancer - You have widespread metastatic disease that is not oligometastatic - You are on active hormone therapy Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.

Locations(1)

University of Wisconsin - Madison

Madison, Wisconsin, United States

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NCT07090148

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