Sipuleucel-T in Metastatic Castrate Resistant Prostate Cancer (CRPC) Patients Previously Treated on Dendreon Study P-11 (NCT00779402)



Status:Completed
Conditions:Prostate Cancer, Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:November 2011
End Date:April 2015

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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)

This study is being conducted to examine the immune response generated by sipuleucel-T in
subjects previously treated with sipuleucel-T in the androgen dependent setting. The study
will also assess the safety of receiving up to 3 additional infusions of sipuleucel-T. This
is an open-label, uncontrolled, multicenter study, conducted in up to 14 clinical trial
sites. The anticipated duration of the study is approximately 6 years.


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, external beam radiation therapy, or any
investigational product for prostate cancer within 28 days prior to registration

- Current or imminent pathologic long-bone fracture

- Known malignancies other than prostate cancer that are 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
We found this trial at
4
sites
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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Laguna Hills, California 92653
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Laguna Hills, CA
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Seattle, Washington 98101
(888) 862-2737
Virginia Mason Medical Center Established in 1920, Virginia Mason began as an 80-bed hospital with...
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Seattle, WA
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Seattle, Washington 98101
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Seattle, WA
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