Can a cancer vaccine plus hormone drugs slow prostate cancer?
NCT ID NCT05751941
First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 2 times
Summary
This study tests whether adding the immune-boosting drug Sipuleucel-T (Provenge) to standard hormone therapy can help men with advanced prostate cancer that is no longer responding to hormones alone. The trial involves 26 participants who will receive either Sipuleucel-T alone or with continued hormone drugs. The goal is to see if the combination activates the immune system more effectively.
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 (Provenge) combined with new hormonal agents (abiraterone, enzalutamide, or apalutamide)
- What this could lead to
- If successful, this combination could improve immune system activation against prostate cancer, potentially delaying disease progression.
- What could go wrong
- This is a small, early-phase trial with only 26 participants, so results may not apply broadly. The treatment may not improve outcomes and could cause side effects from the drugs or infusion.
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 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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26 people
The number who actually took part.
- Started
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Feb 2023
- Expected to finish
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Dec 2026
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: * Asymptomatic or minimally symptomatic metastatic prostate cancer, and the diagnosis of prostate cancer needs to be histologically confirmed by biopsy of the prostate or a metastatic lesion * On combined ADT with LHRH analog and a NHA (enzalutamide, apalutamide or abiraterone) for metastatic prostate cancer with PSA progression, but no imaging progression based on the prostate cancer working group (PCWG) 3 criteria * Age 18 or above * ECOG performance status 0 or 1 * Participants must have adequate organ and marrow function as defined below: * Absolute neutrophil count ≥1,000/mcL * Platelets ≥100,000/mcL * Hemoglobin \> 10 g/dl * AST(SGOT)/ALT(SGPT) ≤3 × institutional ULN * Creatinine 1.5 ≤ institutional ULN * Human immunodeficiency virus (HIV)-infected participants on effective anti-retroviral therapy with undetectable viral load within 6 months are eligible for this trial. * For participants with evidence of chronic hepatitis B virus (HBV) infection, the HBV viral load must be undetectable on suppressive therapy, if indicated * Participants with a history of hepatitis C virus (HCV) infection must have been treated and cured. For participants with HCV infection who are currently on treatment, they are eligible if they have an undetectable HCV viral load * Participants with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with the safety or efficacy assessment of sipuleucel-T are eligible for this trial * No uncontrolled arrhythmia: patients with h/o myocardial infarction or history of congestive heart failure, need to have estimated left ventricle ejection fraction above 40% either on echocardiogram or MUGA scan within 6 months of study enrollment * Non-sterilized men who are sexually active with a female partner of childbearing potential must agree to use adequate contraception prior to the study enrollment, and for the duration of study participation * Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: * Participants who have had chemotherapy or radiotherapy within 4 weeks prior to entering the study * Prior treatment with sipuleucel-T * Participants who have not recovered from adverse events (AEs) due to prior anti-cancer therapy (i.e., have residual toxicities \> Grade 2). * Participants who require \> 50% dose reduction of NHA are excluded from the study except for taking abiraterone at 250 mg with low fat food * Documented brain metastases or liver metastases * Treatment with any investigational compound within 30 days prior to the first dose of Sipuleucel-T * Documented brain metastases or liver metastases * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements * Known history of testing positive for human immunodeficiency virus (HIV) or known acquired immunodeficiency syndrome. HIV-positive participants on combination antiretroviral therapy are ineligible because of the potential for sipluleucel-T to be less clinically active in this population * Inability to comply with protocol requirements
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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.
Contacts and locations
Locations
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Moffitt Cancer Center
Tampa, Florida, 33612, United States
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Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can a 10-Hour eating window fight cancer fatigue?