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

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