Sipuleucel-T Based Autologous Cellular Immunotherapy for Advanced Prostate Cancer

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Pilot Trial to Investigate Immune Response to an Extended Course of Sipuleucel-T Immunotherapy in Patients With Metastatic Castration-resistant Prostate Cancer (OU-SCC-EXCITE)

Conditions
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Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Intervention / Treatment
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* Biological: Sipuleucel-T


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men ≥ 18 years of age Prostate cancer with history of metastasis Candidates for Sipuleucel-T treatment are defined as those with asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Life expectancy of ≥ 6 months Exclusion Criteria: Previously received Sipuleucel-T (Provenge®) Known malignancies other than prostate cancer likely to require treatment within 6 months following registration A requirement for systemic immunosuppressive therapy (>10mg Prednisone daily or equivalent) A history of allergic reactions attributed to compounds of similar chemical or biologic composition to Sipuleucel-T or GM-CSF Any infection requiring antibiotic therapy within 1 week prior to registration

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: The primary objective is to evaluate the feasibility and immune response of an extended course of Sipuleucel-T immunotherapy given at week 0, 2, and 12-14 in patients with metastatic castration-resistant prostate cancer.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Extended course of Sipuleucel-T treatment<br> | Biological: Sipuleucel-T<br>* 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.<br>* Other names: PROVENGE;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion 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. | 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. | up to 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | up to 12 Months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antigen presenting cells (APCs), Sipuleucel-T (Sip-T), granulocyte-macrophage colony-stimulating factor (GM-CSF), prostatic acid phosphatase (PAP)