This phase I trial compares the effect of lutetium Lu 177 (177\^Lu)-prostate-specific membrane antigen (PSMA)-617 in combination with Sipuleucel-T to 177\^Lu-PSMA-617 alone in treating patients with prostate that has spread from where it first started (primary site) to other places in the body (metastatic) and has continued to grow and spread despite surgical or medical intervention to block androgen production (castration-resistant). 177\^Lu-PSMA-617, a type of radioconjugate, binds to a protein called PSMA, which is found on some prostate tumor cells. It gives off radiation that may kill the tumor cells. Sipuleucel-T, a type of vaccine and a type of cellular adoptive immunotherapy, is made from immune system cells. The cells are treated with a protein that is made by combining a protein found on prostate tumor cells with a growth factor. When the cells are injected back into the patient, they may stimulate T cells to kill prostate tumor cells. Giving 177\^Lu-PSMA-617 in combination with sipuleucel-T may be safe, tolerable, and/or effective compared to 177\^Lu-PSMA-617 alone in treating patients with metastatic castration-resistant prostate cancer.
PRIMARY OBJECTIVE: I. To evaluate the immune response induced by the combination of lutetium Lu 177 vipivotide tetraxetan (177\^Lu-PSMA-617) and sipuleucel-T, using changes in anti-prostatic acid phosphatase (PAP) immunoglobulin G (IgG) antibody titers. SECONDARY OBJECTIVES: I. To evaluate anti-PA2024 antibody titers in patients receiving 177\^Lu-PSMA-617 alone versus in combination with sipuleucel-T. II. To assess the safety and tolerability of 177\^Lu-PSMA-617 plus sipuleucel-T. III. To evaluate the clinical efficacy of 177\^Lu-PSMA-617 alone versus in combination with sipuleucel-T. EXPLORATORY OBJECTIVES: I. To characterize the pharmacokinetics (PK) of 177\^Lu-PSMA-617 plus sipuleucel-T in the blood. II. To determine the impact of 177\^Lu-PSMA-617 in combination with sipuleucel-T on systemic immunomodulation. OUTLINE: Patients are randomized to 1 of 2 arms. ARM A (CONTROL GROUP): Patients receive 177\^Lu-PSMA-617 intravenously (IV). Treatment repeats every 6 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo blood sample collection, PSMA positron emission tomography (PET)/computed tomography (CT), bone scan, and magnetic resonance imaging (MRI) throughout the study. Additionally, patients may undergo MRI or CT of the brain throughout the study. ARM B (EXPERIMENTAL GROUP): Patients receive 177\^Lu-PSMA-617 IV. Treatment repeats every 6 weeks for up to 6 cycles in the absence of disease progression or unacceptable toxicity. Starting during week 8 of treatment, patients receive sipuleucel-T IV over 1 hour. Treatment repeat every 2 weeks for up to 3 doses in the absence of disease progression or unacceptable toxicity. Patients also undergo leukapheresis, blood sample collection, PSMA PET/CT, bone scan, and MRI throughout the study. Additionally, patients may undergo MRI or CT of the brain throughout the study. After completion of study treatment, patients are followed up at 30 days, every 3 months for up to 1 year then every 6 months until progression followed by survival follow until death or withdrawal of consent.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
Undergo blood sample collection
Undergo bone scan
Undergo CT and PSMA PET/CT
Undergo leukapheresis
Given IV
Undergo MRI
Undergo PSMA PET/CT
Given IV
City of Hope Medical Center
Duarte, California, United States
RECRUITINGAnti-prostatic acid phosphatase (PAP) immunoglobulin G (IgG) antibody response rate
Will be defined as the proportion of patients with an IgG titer \> 400. Comparisons between study arms will be performed using the Fisher's exact test. Descriptive statistics will be used to summarize the antibody response rates, and Clopper-Pearson exact 95% confidence intervals will be calculated.
Time frame: Between week 7 and week 19
Change in anti-PAP IgG antibody titers
Descriptive statistics will be used to summarize antibody titer levels at each time point. Comparisons between study arms will be performed using the Wilcoxon signed-rank test or Student's t-test, as appropriate.
Time frame: Between week 7 and week 19
Change in anti-PA2024 antibody titers
Descriptive statistics will be used to summarize antibody titer levels at each time point. Comparisons between study arms will be performed using the Wilcoxon signed-rank test or Student's t-test, as appropriate.
Time frame: Between week 7 and week 19
Incidence of adverse events
Comparison of toxicities will be assessed using Common Terminology Criteria for Adverse Events version (v) 5.0 criteria.
Time frame: Up to 30 days after last dose of study treatment
Proportion of patients achieving a ≥ 50% reduction in prostate specific antigen (PSA) levels (PSA50 response rate)
The PSA50 response rate will be calculated for each treatment arm as the proportion of patients achieving PSA50 response among all evaluable patients. A Fisher's exact test will be used to compare response rates between arms.
Time frame: At baseline up to 3 years
Objective response rate
The association between treatment arm and overall response as per RECIST v 1.1 criteria (response observed versus not observed) will be examined using Fisher's exact test.
Time frame: Up to 3 years
Radiographic progression-free survival (rPFS)
Will be evaluated using Prostate Cancer Clinical Trial Working Group 3 and RECIST v 1.1 criteria. The median rPFS will be estimated using the Kaplan-Meier method.
Time frame: From enrollment to progression or death from any cause, assessed up to 3 years
Overall survival
Will be estimated using the Kaplan-Meier method.
Time frame: From enrollment to death from any cause, assessed up to 3 years
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