Sipuleucel-T in Metastatic Castrate Resistant Prostate Cancer

Stopped early · Phase 2

Conditions studied: Prostate Cancer

In brief

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.

Key facts

Study ID

NCT01338012

Run by

Dendreon

People needed

8

Starts

2011-12-01

Expected to finish

2015-04-01

Last updated by the study team

2017-06-05

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Orange County Urology Associates — Laguna Hills, California, United States
• Oregon Health & Science University — Portland, Oregon, United States
• Virginia Mason Hospital — Seattle, Washington, United States
• Virginia Mason Medical Center — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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