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Study of Sipuleucel-T with or without New Hormonal Agents for Metastatic Prostate Cancer

This study is looking at how Sipuleucel-T (Provenge), a standard treatment, works when given with or without other hormone-blocking medicines like Abiraterone, Enzalutamide, or Apalutamide. It's for men with prostate cancer that has spread (metastatic prostate cancer) but isn't causing many symptoms. Researchers want to see if combining these treatments helps activate certain immune cells (antigen presenting cells or APC) more effectively. To join, you need to be a man at least 18 years old with metastatic prostate cancer that has been confirmed by a biopsy. You also need to be currently taking hormone therapy (ADT with LHRH analog and a new hormonal agent) for your metastatic prostate cancer, and your PSA levels should be rising, but your scans shouldn't show new spread of the cancer. The study plans to enroll 26 participants, but its current status is unclear.

Study design
This is an interventional study with an unclear phase, planning to enroll 26 male participants. It is designed to test a hypothesis about combining treatments.
What's involved
You would receive Sipuleucel-T infusions three times over approximately four weeks. You would also continue taking Abiraterone, Enzalutamide, or Apalutamide, with Enzalutamide and Apalutamide ending at week 4.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome, cumulative APC activation, is measured at Week 4.

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NCT05751941

Study of Sipuleucel-T With or Without Continuing New Hormonal Agents in Metastatic Prostate Cancer

Active, Not Recruiting
PHASE2Ages 18+InterventionalTreatment
H. Lee Moffitt Cancer Center and Research Institute
~26 participants
Updated 2026-06-24 on ClinicalTrials.gov
What's tested:AbirateroneEnzalutamideApalutamideSipuleucel-T

At a glance

Recruiting sites
0 of 2 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cumulative APC Activation
Measured over At Week 4

Conditions

Prostate Cancer
Metastatic Prostate Cancer

Explore related trials

Prostate Carcinoma

Where it's being run

2 sites across 2 states
Florida1
Ohio1

Study leadership

  • Jingsong Zhang, MD, PhD · PRINCIPAL_INVESTIGATOR · Moffitt Cancer Center

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

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

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

What this trial measures

  • Cumulative APC ActivationAt Week 4

    Cumulative APC activation is calculated as the sum of APC activation across 0, 2, and 4 weeks