Proposed immunotherapy with an extended course of Sipuleucel-T treatment may induce a more robust immune response and improve the anti-cancer efficacy of Sipuleucel-T in patients with metastatic Castration-Resistant Prostate Cancer (mCRPC).
This open-label, pilot trial aims to evaluate the feasibility of Sipuleucel-T given in three doses at weeks 0, 2, and 12-14; and to investigate the changes in immune response in mCRPC patients who are getting an extended course of Sipuleucel-T treatment.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
13
Three doses of Sipuleucel-T, each containing a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF, given at week 0, 2, and 12-14.
University of Oklahoma Health Sciences Center, Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
RECRUITINGProportion of patients completing 3 doses of Sipuleucel-T immunotherapy.
Patients will be treated with Sipuleucel-T immunotherapy and the treatment regimen will be considered feasible if 85% of enrolled patients complete all three infusions of Sipuleucel-T treatment given at week 0, 2 and 12-14.
Time frame: up to 5 months
Proportion of subjects who have detectable elevated IgG level and/or T-cell proliferation from baseline to the follow-up of extended course of Sipuleucel-T immunotherapy.
For patients undergoing Sipuleucel-T treatment on weeks 0, 2 and 12-14, the changes in immune response will be measured based on the detectable elevated levels of IgG and/or T-cell proliferation against various types of prostate cancer associated antigens at baseline, and at Sipuleucel-T infusion doses given at week 0, 2 and 12-14 weeks.
Time frame: up to 12 Months
Evaluate the mean difference in immune response to Sipuleucel-T treatment among different racial groups.
Potential difference of immune response to Sipuleucel-T immunotherapy given at weeks 0, 2 and 12-14 will be compared in patients with mCRPC of different racial groups using the one-way ANOVA or the Kruskal-Wallis test.
Time frame: up to 12 months
Evaluate the potential tumor response based on the changes in serum PSA at baseline and within 30 days of last dose.
For patients undergoing Sipuleucel-T treatment on weeks 0, 2 and 12-14, the preliminary tumor response will be measure through the comparison of serum PSA level between baseline and within 30 days of last dose.
Time frame: up to 12 Months
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