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Study of Androgen Deprivation with pTVG-AR and T-Cell Checkpoint Blockade for High-Risk Prostate Cancer

This study is for men with newly diagnosed, high-risk prostate cancer who are planning to have surgery (prostatectomy). It investigates whether adding a DNA vaccine called pTVG-AR, with or without other drugs like Nivolumab, Cemiplimab, or Fianlimab, can improve treatment when combined with standard androgen deprivation therapy (Degarelix). The study aims to see if these additions can create or boost immune cells (T-cells) to fight the cancer. Researchers will measure how many participants have no cancer cells left after surgery (pathological complete response rate) and how many have very few remaining cancer cells (minimal residual disease rate), as well as any side effects. You might be eligible if you have high-risk prostate cancer, no spread of cancer, and are a candidate for prostatectomy.

Study design
This interventional study plans to enroll 57 participants. It involves different treatment arms, where participants will be randomized to receive various combinations of the study drugs.
What's involved
All participants will receive Degarelix for 8 weeks before surgery. The study involves treatment for up to 15 months.
Compensation
Not stated in the trial record.
Follow-up
Researchers will monitor for side effects for up to 15 months. Pathological complete response and minimal residual disease will be measured at prostatectomy (up to 3 months).

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04989946

Androgen Deprivation, With or Without pTVG-AR, and With or Without T-Cell Checkpoint Blockade, in Patients With Newly Diagnosed, High-Risk Prostate Cancer

Active, Not Recruiting
PHASE1Ages 18+InterventionalTreatment
University of Wisconsin, Madison
~57 participants
Updated 2026-07-02 on ClinicalTrials.gov
What's tested:DegarelixpTVG-ARNivolumabCemiplimabFianlimabFLT PET/CT

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pathological Complete Response Rate (pCR)
Measured over at prostatectomy (up to 3 months)
+3 more outcomes measured

Conditions

Prostate Cancer

Explore related trials

Prostate CarcinomaKLK3 Gene

Where it's being run

1 sites across 1 states
Wisconsin1

Study leadership

  • Christos Kyriakopoulos, MD · PRINCIPAL_INVESTIGATOR · University of Wisconsin, Madison

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Histologically confirmed adenocarcinoma of the prostate
Patients must be considered candidates for prostatectomy as per standard of care
High-risk patients for recurrent disease, with high risk defined based on one of the following criteria:
Gleason score 7 and baseline serum prostate specific antigen (PSA) \> 20 ng/mL
Gleason score \> 7
Life expectancy of at least 12 months at screening
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Adequate hematologic, renal and liver function as evidenced by the following within 4 weeks of day 1:
Absolute neutrophil count (ANC) \> 1000 / mm3
HgB \> 9.0 gm/dL independent of transfusion
Platelets \> 100,000 / mm3
Creatinine \< 2.0 mg/dL
Aspartate aminotransferase (AST), Alanine transaminase (ALT) \< 2.5 x institutional upper limit of normal (ULN)
Total bilirubin \< 2x institutional ULN (NOTE: in subjects with Gilbert's syndrome, if total bilirubin is \>2x ULN, measure direct and indirect bilirubin and if direct bilirubin is within normal range, subject may be eligible)
No known history of HIV 1 and 2, HTLV-1, or active Hepatitis B or Hepatitis C
Must have adequate tissue (ten 5µm unstained formalin-fixed paraffin-embedded (FFPE) sections containing prostate cancer) remaining from pre-treatment diagnostic prostate biopsy for research purposes
Patients must be willing to undergo large-volume blood draws (up to 200mL per time point) for the investigational component of this trial
For those patients who are sexually active, they must be willing to use barrier contraceptive methods during the period of treatment on this trial
Patients 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
Ability to comply with all study procedures and willingness to remain supine for 120 minutes during imaging

Exclusion

Small cell or other variant (non-adenocarcinoma) prostate cancer histology
Prior treatment for prostate cancer, including androgen deprivation therapy (ADT), orchiectomy, antiandrogens, ketoconazole, abiraterone acetate or enzalutamide
Prior radiation to the prostate
Patients may not be receiving other investigational agents or be receiving concurrent anticancer therapy other than the treatment-prescribed androgen deprivation therapy
Treatment with any of the following medications while on study is prohibited, washout period not required except as indicated:
Systemic corticosteroids (at doses over the equivalent of 10 mg prednisone daily) - not permitted within 3 months of registration; inhaled, intranasal or topical corticosteroids are acceptable
PC-SPES
Herbal supplements that have been shown to modulate testosterone or androgen signaling (e.g. Saw Palmetto) are not allowed while on study
Megestrol
Ketoconazole
5-α-reductase inhibitors - patients already taking 5-α-reductase inhibitors prior to 28 days prior to registration may stay on these agents throughout the course of therapy, but these should not be started while patients are on study
Diethylstilbesterol
Any other non-study hormonal agent or supplement being used with the intent of cancer treatment
Major surgery within 4 weeks of registration is prohibited
Active cardiac disease defined as active angina, symptomatic congestive heart failure, or myocardial infarction within 6 months of registration
Patients with known psychological or sociological conditions, addictive disorders or family problems, which would preclude compliance with the protocol
Patients who have undergone splenectomy
Patients must not have other active malignancies other than non-melanoma skin cancers or superficial bladder cancer (this includes any non-muscle invasive bladder cancer including Ta, CIS and T1), that have been adequately treated. Subjects with a history of other cancers who have been adequately treated and have been recurrence-free for \> 3 years are eligible.
Any other medical intervention or condition, which, in the opinion of the principle investigator (PI) or treating physician, could compromise patient safety or adherence with the study requirements over the primary 3-6 month treatment period.
Patients who have concurrent enrollment on other phase I, II, or III investigational treatment studies cannot be actively receiving treatment and the last dose cannot be within 4 weeks.
Patients who have received a live vaccine within 14 days prior to the first dose of study treatment. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette-Guérin (BCG), and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed
Patients with a history of life-threatening autoimmune disease or active autoimmune disease that has required systemic treatment in the past 2 years (i.e. with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (eg., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency, etc.) is not considered a form of systemic treatment
Patients with a history of non-infectious pneumonitis that required corticosteroid treatment, or has current pneumonitis
Patients with a history of allergic reactions to the tetanus vaccine

What this trial measures

  • Pathological Complete Response Rate (pCR)at prostatectomy (up to 3 months)

    The pathological complete response will be estimated for each arm and reported along with the corresponding 95% confidence interval which will be constructed using the Wilson score method. Formal comparisons between arms will be conducted using Fisher's exact test. Participants in this study with unknown pathological response will be treated as non-responders in the primary analysis.

  • Minimal Residual Disease (MRD) Rateat prostatectomy (up to 3 months)

    The MRD rate will be estimated for each arm and reported along with the corresponding 95% confidence interval which will be constructed using the Wilson score method. Formal comparisons between arms will be conducted using Fisher's exact test. Participants in this study with unknown pathological response will be treated as non-responders in the primary analysis.

  • Incidence of Adverse Eventsup to 15 months

    Adverse events will be evaluated using the most recent version of the Common Terminology Criteria for Adverse Events (CTCAE).

  • Toxicity Ratesup to 15 months

    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.