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An Open Label Study of Sipuleucel-T in Men With Metastatic Castrate Resistant Prostate Cancer

Phase 2
18 Years
Open (Enrolling)
Prostate Cancer

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Trial Information

An Open Label Study of Sipuleucel-T in Men With Metastatic Castrate Resistant Prostate Cancer

Subjects will receive the investigational product, sipuleucel-T, at approximately 2-week
intervals, for a total of 3 infusions. The study will evaluate the safety of and magnitude
of the immune responses to treatment with sipuleucel-T. All subjects will be followed for 30
days following the last infusion of sipuleucel-T. The study is also available to placebo
subjects who participated in the D9902B study.

Inclusion Criteria:

For a subject to be eligible for participation in this study, all of the following
criteria must be satisfied.

- Histologically documented adenocarcinoma of the prostate.

- Metastatic disease.

- Castrate resistant prostate cancer.

- Castrate level of testosterone (< 50 ng/dL) achieved via medical or surgical

- Life expectancy of at least 3 months.

- Men >= 18 years of age.

- Adequate hematologic, renal and liver function.

Exclusion Criteria:

A subject will not be eligible for participation in this study if any of the following
criteria apply.

- The presence of known lung, liver, or brain metastases.

- Evidence of neuroendocrine or small cell features.

- Eastern Cooperative Oncology Group (ECOG) performance status > 2.

- Prior treatment with 3 infusions of sipuleucel-T (infusions of APC8015F are not

- Imminent pathologic long-bone fracture (cortical erosion on radiography > 50%) or
spinal cord compression.

- Known malignancies other than prostate cancer that are likely to require treatment
within six months of 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 parenteral antibiotic therapy or causing fever (temp > 100.5F
or > 38.1C) within 1 week prior to registration.

- Any medical intervention or other condition which, in the opinion of the Principal
Investigator or the Dendreon Medical Monitor, could compromise adherence with study
requirements or otherwise compromise the study's objectives.

Treatment with any of the following medications or interventions within 28 days of

- Systemic corticosteroids. Use of inhaled, intranasal, intra-articular, and topical
steroids is acceptable, as is a short course (ie, ≤ 1 day) of corticosteroids to
prevent a reaction to the IV contrast used for CT scans.

- Non-steroidal anti-androgens (eg, bicalutamide, flutamide, or nilutamide).

- External beam radiation therapy or major surgery requiring general anesthetic.

- Any other systemic therapy for prostate cancer including secondary hormonal
therapies, such as megestrol acetate (Megace®), diethylstilbestrol (DES), and
ketoconazole. Medical castration therapy is not exclusionary.

- Chemotherapy.

- Treatment with any other investigational product.

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Evaluate the magnitude of immune responses to treatment with sipuleucel-T

Outcome Time Frame:


Safety Issue:



United States: Food and Drug Administration

Study ID:




Start Date:

August 2009

Completion Date:

December 2013

Related Keywords:

  • Prostate Cancer
  • AIPC
  • CRPC
  • prostate cancer
  • prostate
  • immune therapy
  • immunotherapy
  • vaccine
  • dendritic cells
  • antigen-presenting cells
  • antigen presenting cells
  • cancer vaccine
  • PSA
  • prostatic adenocarcinoma
  • Prostatic Neoplasms



NYU Cancer InstituteNew York, New York  10016
The University of Chicago Medical CenterChicago, Illinois  60637-1470
Georgetown University Medical CenterWashington, District of Columbia  20007
Oncology Specialists, S.C.Park Ridge, Illinois  60068
Columbia University Medical CenterNew York, New York  10032
Maine Center for Cancer MedicineScarborough, Maine  04074
Sarah Cannon Research InstituteNashville, Tennessee  37203
Virginia Mason Medical Center Urology and Renal TransplantationSeattle, Washington  98101
Indiana University Department of UrologyIndianapolis, Indiana  46202
Myron I. Murdock MD LLCGreenbelt, Maryland  20770
Hematology Oncology ConsultantsGreenbelt, Maryland  20770
Mount Sinai School of Medicine Department of UrologyNew York, New York  10029
GU Oncology Research ProgramDurham, North Carolina  27710
Texas Oncology, PA - Sammons Cancer CenterDallas, Texas  75246
Urology of Virginia/ SentaraNorfolk, Virginia  23502
Aurora Advanced Healthcare, IncWauwatosa, Wisconsin  53226