Can a vaccine plus immune booster tackle resistant prostate cancer?
NCT ID NCT07756593
First seen Aug 10, 2026 · Last updated Aug 11, 2026 · Updated 1 time
Summary
This early-phase trial is testing whether combining two immune-based treatments—Sipuleucel-T, a vaccine made from a patient's own immune cells, and N-803, a drug that boosts immune activity—is safe and tolerable for men with metastatic prostate cancer that has stopped responding to hormone therapy. The study enrolls 30 participants and aims to find the best dose of N-803 to use with the standard Sipuleucel-T regimen. Researchers will monitor side effects and also look at whether the combination affects PSA levels, a marker of prostate cancer activity.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Sipuleucel-T (a cellular vaccine) combined with N-803 (an immune-boosting biologic)
- What this could lead to
- If safe and effective, this combination could offer a new treatment option for metastatic prostate cancer that has stopped responding to hormone therapy.
- What could go wrong
- This is an early-phase trial with only 30 participants, so results may not apply broadly. The combination could cause significant side effects, and it's unclear if it will improve outcomes.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 30 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Nov 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2031
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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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 Hide 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: * Histologically or cytologically confirmed prostate adenocarcinoma. * Imaging- or biopsy-proven metastatic disease. May have any type or location of metastases (bone, lymph node, visceral). * Prior treatment must include either orchiectomy or luteinizing hormone-releasing agonist or antagonist treatment with documented testosterone ≤ 50 ng/dL. * Eligible for standard of care Sipuleucel-T. * Recovery to baseline or ≤ grade 1 from toxicities related to any prior treatments, unless AEs are clinically nonsignificant and/or stable on supportive therapy. * At least 18 years of age. * ECOG performance status ≤ 2 * Adequate bone marrow and organ function as defined below: * Absolute neutrophil count ≥ 1,500 K/cumm without granulocyte colony-stimulating factor support * Platelets ≥ 100,000 K/cumm without transfusion * Hemoglobin ≥ 10.0 g/dL * Total bilirubin ≤ 1.5 x IULN * AST(SGOT) and ALT(SGPT) ≤ 2.5 x IULN * Calculated creatinine clearance ≥ 50 mL/min by Cockcroft-Gault * PSA ≤ 200 ng/mL. * Ability to understand and willingness to sign an IRB approved written informed consent document. Legally authorized representatives may sign and give informed consent on behalf of study participants Exclusion Criteria: * Rapidly progressing disease or symptomatic prostate cancer as assessed by the investigator. * Prior immunotherapy (e.g., anti-PD-1, anti-PD-L1, anti-CTLA4) within the 6 months prior to enrollment. * Prior systemic radiotherapy (such as Ra-223, Lu177-PSMA) within the 6 months prior to enrollment. Prior palliative radiation therapy for bone metastasis within 2 weeks or any other radiation therapy within 4 weeks before first dose of study treatment is allowed. Prior definitive radiation therapy for localized prostate cancer is allowed. * Prior exposure to Sipuleucel-T. * Ongoing systemic immune suppression (oral steroids equivalent to 10 mg daily prednisone or less are allowed; topical, inhaled, and intra-articular steroids are allowed). * Currently receiving any other investigational therapeutic or imaging agents. * Patients with known brain metastases or cranial epidural disease unless adequately treated with radiotherapy and/or surgery (including radiosurgery) and stable for at least 4 weeks prior to first dose of study treatment after radiotherapy or at least 4 weeks prior to first dose of study treatment after major surgery (e.g., removal or biopsy of brain metastasis). Subjects must have complete wound healing from major surgery or minor surgery before first dose of study treatment. Eligible subjects must be neurologically asymptomatic and without corticosteroid treatment at the time of first dose of study treatment. * A history of allergic reactions attributed to compounds of similar chemical or biologic composition to Sipuleucel-T or N-803 or other agents used in the study. * Uncontrolled intercurrent illness including, but not limited to: ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia. Patients with a known history or current symptoms of cardiac disease, or history of treatment with cardiotoxic agents, should have a clinical risk assessment of cardiac function using the New York Heart Association Function Classification; to be eligible for this trial, patients should be a class 2B or better. * HIV-infected if not on effective anti-retroviral therapy with undetectable viral load for 6 months. Patients with HIV who are receiving effective anti-retroviral therapy and have had an undetectable viral load for at least 6 months are eligible. HIV testing not required in the absence of known history of infection. * Evidence of chronic hepatitis B virus (HBV) that is detectable on suppressive therapy. Patients with evidence of chronic HBV infection with undetectable HBV viral load on suppressive therapy are eligible. HBV testing not required in the absence of known history of infection. * History of hepatitis C virus (HCV) infection that has not been cured or that has a detectable viral load. Patients with a history of HCV that has been treated and cured are eligible. Patients with HCV infection who are currently on treatment and have an undetectable HCV viral load are eligible. HCV testing not required in the absence of known history of infection. * Uncontrolled infection with hepatitis A.
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
Locations
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Washington University School of Medicine
St Louis, Missouri, 63110, United States
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Other studies related to the condition(s) this trial covers.
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- A scanner in the operating room could show surgeons exactly where prostate cancer remains