Sipuleucel-T in Metastatic Castrate Resistant Prostate Cancer

Phase 2

Terminated

Brief Summary: 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: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
sipuleucel-T	sipuleucel-T	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.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method

Locations (4): Virginia Mason Hospital
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Seattle, Washington, United States
Oregon Health & Science University
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Portland, Oregon, United States
Orange County Urology Associates
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Laguna Hills, California, United States
Virginia Mason Medical Center
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Seattle, Washington, United States