A Phase II Randomized Study of Sipuleucel-T With or Without Continuing New Hormonal Agents (NHA) in Metastatic Prostate Cancer With PSA Progression While on NHA and LHRH Analog
This study is designed to test the hypothesis that using Sipuleucel-T (Provenge) in combination with new hormonal agents (NHA) (abiraterone, enzalutamide, apalutamide) for the treatment of participants with asymptomatic metastatic castration resistant prostate cancer (mCRPC) and no visceral metastases would enhance the activation of antigen presenting cells (APC) by sipuleucel-T.
• 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