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Experimental DNA vaccine aims to train immune system against prostate cancer

NCT ID NCT07090148

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial tests whether an experimental DNA vaccine (pTVG-HP) combined with the immunotherapy drug nivolumab and targeted radiation can help the immune system attack prostate cancer that has returned in a few spots. The study involves 14 men whose cancer has come back after prostate removal but who still have normal testosterone levels. The main goals are to see if the treatment can lower PSA levels and to check for side effects.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 14 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2026

Expected to finish

Oct 2030

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 (if required), at least 3 months prior to entry, with removal or ablation of all visible disease, including seminal vesical and/or local lymph node involvement. * Participants must have biochemically recurrent disease defined by the following: * PSA doubling time, calculated from most recent 4 serum PSA values (collected up to one year prior to enrollment, at least 2 weeks apart, and all from the same clinical laboratory), must be a positive number (i.e. evidence of PSA rise over time). * Participants must have oligometastatic disease, defined as: * \< 3 lesions consistent with metastases as detected by CT of the abdomen/pelvis and bone scintigraphy (bone scan) * Lesions consistent with metastatic prostate cancer as detected by PSMA PET/CT * Participants with a prior history of a second malignancy are eligible provided they have been treated with curative intent and have been free of disease greater than three years. There will be no exclusion for patients with a history of basal cell carcinoma, squamous cell skin cancer, superficial bladder cancer, or other in situ carcinoma that has been adequately treated. * Participants who are sexually active must use a reliable form of contraception while on study and for 4 weeks after the last immunization. * ECOG performance score \< 2 and life expectancy of at least 12 months. * Participants must have normal hematologic, renal and liver function * Participants must be informed of the experimental nature of the study and its potential risks and must sign an IRB-approved written informed consent form indicating such an understanding. * Willingness to provide blood samples for immune studies, per study calendar, up to one year after study, even if off treatment. Exclusion Criteria: * Small cell or other variant prostate cancer histology * Participants cannot have evidence of immunosuppression or have been treated with immunosuppressive therapy, such as chemotherapy or chronic treatment dose corticosteroids (greater than the equivalent of 10 mg prednisone per day), within 3 months of the first vaccination. * Seropositive for HIV, hepatitis B (HBV) or hepatitis C (HCV) per patient history due to the immunosuppressive features of these diseases. * Prior treatment with an LHRH agonist or nonsteroidal antiandrogen, except in the following circumstances: Neoadjuvant/adjuvant androgen deprivation therapy administered with radiation therapy or at the time of prostatectomy is acceptable, provided that there was no evidence of PSA progression while on treatment. In this situation, patients must not have received more than 24 months of androgen deprivation treatment. Other treatment with androgen deprivation therapy is prohibited. * Serum testosterone at screening \< 50 ng/dL. * Participants must not be concurrently taking other medications or supplements with known hormonal effects, including PC-SPES, megestrol acetate, finasteride, ketoconazole, estradiol, or Saw Palmetto. All other medications with possible anti-cancer effects must be discussed with the PI prior to study entry. * Participants previously treated with other potential or experimental therapies for prostate cancer must have discontinued these treatments and completed at least a 4 week washout prior to beginning treatment. * Participants must not have known psychological or sociological conditions, addictive disorders or family problems, which would preclude compliance with the protocol. * Participants with unstable or severe intercurrent medical conditions or laboratory abnormalities that would impart, in the judgment of the PI, excess risk associated with study participation or study agent administration. * Participants who have concurrent enrollment on other phase I, II, or III investigational therapeutic treatment studies for prostate cancer cannot be actively receiving treatment and the last dose cannot be within 4 weeks of day 1. They must be in the follow up phase of the study.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    1 site. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • University of Wisconsin - Madison

    RECRUITING

    Madison, Wisconsin, 53705, United States

    Contact Email: •••••@•••••

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