Sipuleucel-T in Metastatic Castrate Resistant Prostate Cancer

Study Overview
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Brief Summary
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Multicenter open label, uncontrolled study that enrolled men with metastatic castrate resistant prostate cancer previously treated with sipuleucel-T in the androgen dependent setting in the Dendreon P-11 study. The study was divided into Active and Long Term Follow-up (LTFU) Phases.

Detailed Description
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Multicenter open label, uncontrolled study that enrolled men with metastatic castrate resistant prostate cancer previously treated with sipuleucel-T in the androgen dependent setting in the Dendreon P-11 study. The study was divided into Active and Long Term Follow-up (LTFU) Phases. During the Active Phase eligible subjects received one infusion of sipuleucel-T every two weeks for for a total of three infusions. Subjects returned to the clinic for Week 6, Week 10, Month 6, and Month 12 visits. After the Month 12 visit, subjects were to enter the Long Term Follow-up Phase, in which they were contacted every 6 months via telephone. Study Objectives: Primary: Evaluate the immune response generated by sipuleucel-T. Secondary: Evaluate the safety of sipuleucel-T and explore the correlation between sipuleucel-T immune response and overall survival.

Official Title
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An Open-Label Multicenter Study of Sipuleucel-T in Metastatic Castrate Resistant Prostate Cancer Patients Previously Treated With Sipuleucel-T on Dendreon Study P-11 (NCT00779402)

Conditions
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Prostate Cancer

Intervention / Treatment
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* Biological: sipuleucel-T


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Previously randomized in Dendreon's P-11 study (NCT00779402) and received at least one infusion of sipuleucel-T Radiologic evidence of metastasis Castrate resistant prostate cancer. Subjects must have current or historical evidence of disease progression concomitant with surgical or medical castration, as demonstrated by PSA progression OR progression of measurable disease OR progression of non-measurable disease Castrate level of testosterone (< 50 ng/dL) achieved via medical or surgical castration Adequate hematologic function Exclusion Criteria: Eastern Cooperative Oncology Group (ECOG) performance status > 2 Treatment with chemotherapy within 3 months prior to registration Treatment with systemic corticosteroids, abiraterone acetate, external beam radiation therapy, or any investigational product for prostate cancer within 28 days prior to registration Treatment with commercial sipuleucel-T (Provenge®) Current or imminent pathologic long-bone fracture or spinal cord compression Known malignancies other than prostate cancer likely to require treatment within 6 months following registration A requirement for systemic immunosuppressive therapy for any reason 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 or causing fever within 1 week prior to registration Any surgery requiring general anesthetic within 28 days 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: sipuleucel-T<br>Men with metastatic castrate resistant prostate cancer previously treated with sipuleucel-T in the androgen dependent setting in the Dendreon P-11 study. Subjects received one infusion of sipuleucel-T every two weeks for for a total of three infusions. | Biological: sipuleucel-T<br>* Sipuleucel-T is an autologous cellular product consisting of antigen presenting cells (APCs) activated with PA2024, a recombinant fusion protein composed of prostatic acid phosphatase (PAP), linked to granulocyte-macrophage colony-stimulating factor (GM-CSF).<br>* Other names: PROVENGE, APC8015;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Study Participants Enrolled and Treated Prior to Study Termination | Number of study participants that were enrolled and treated in this trial following completion of study P-11 and prior to study termination. | Study duration: date of first subject registration Dec 2011 and date of last subject visit April 2015 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antigen-presenting cells, antigen presenting cells, metastatic castrate resistant prostate cancer, prostate cancer, prostate, immune therapy, immunotherapy, vaccine, dendritic cells, cancer vaccine, prostatic adenocarcinoma, Sipuleucel-T, castration resistant prostate cancer (CRPC), booster, retreatment, immune memory, immune response