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

Phase 2
18 Years
Open (Enrolling)
Cancer of Prostate, Cancer of the Prostate, Neoplasms, Prostate, Neoplasms, Prostatic, Prostate Cancer, Prostate Neoplasms, Prostatic Cancer

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Trial Information

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

Inclusion Criteria:

- Histologically documented adenocarcinoma of the prostate

- Metastatic disease as evidenced by soft tissue and/or bony metastases on bone scan
and/or computed tomography (CT) scan of the abdomen and pelvis at any time prior to

- Castrate resistant prostate cancer

- Serum PSA ≤ 5.0 ng/mL

- Castration levels of testosterone (≤ 50 ng/dL; ≤ 1.74 nmol/L) achieved via medical or
surgical castration. Surgical castration must have occurred at least 3 months prior
to registration.

- ECOG performance status ≤ 1

- Adequate hematologic, renal, and liver function

- Negative serology tests indicating no active infection with human immunodeficiency
virus types 1 and 2 (HIV-1/2), human T cell lymphotropic virus types 1 and 2
(HTLV-I/II), and Hepatitis B and C viruses.

Exclusion Criteria:

- The presence of known brain metastases

- A requirement for systemic immunosuppressive therapy for any reason

- Treatment with any investigational vaccine within 2 years prior to registration

- Any previous treatment with sipuleucel-T

- Any previous treatment with ipilimumab (Yervoy[TM], MDX-010, or MDX-101) or denosumab

- Pathologic long-bone fractures, 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 6 months of registration

- A history of allergic reactions attributed to compounds of similar chemical or
biologic composition to sipuleucel-T or GM-CSF

- More than 2 chemotherapy regimens at any time prior to registration

- Treatment with any chemotherapy within 90 days of registration

- Received granulocyte colony-stimulating factor (G-CSF) or GM-CSF within 90 days prior
to registration

- 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 (i.e., ≤ 1 day) of corticosteroids to
prevent a reaction to the IV contrast used for CT scans.

- Non-steroidal anti-androgens (e.g., 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.

- Immunosuppressive therapy

- Treatment with any other investigational product

- Any infection requiring parenteral antibiotic therapy or causing fever (temperature >
100.5°F or 38.1°C) within 7 days prior to registration.

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

Type of Study:


Study Design:

Intervention Model: Single Group Assignment, Masking: Open Label

Outcome Measure:

A descriptive summarization of key product parameters for sipuleucel-T produced at a European manufacturing facility.

Outcome Description:

Key product parameters are measured with each product manufactured and will be summarized: CD54+ cell count cumulative CD54 upregulation cumulative total nucleated cell (TNC) count product viability (percentage)

Outcome Time Frame:

Approximately 1 month from first product manufactured

Safety Issue:


Principal Investigator

Andrew Stubbs, PhD

Investigator Role:

Study Director

Investigator Affiliation:



United Kingdom: Medicines and Healthcare Products Regulatory Agency

Study ID:




Start Date:

June 2012

Completion Date:

January 2014

Related Keywords:

  • Cancer of Prostate
  • Cancer of the Prostate
  • Neoplasms, Prostate
  • Neoplasms, Prostatic
  • Prostate Cancer
  • Prostate Neoplasms
  • Prostatic Cancer
  • prostate cancer
  • prostate
  • immune therapy
  • immunotherapy
  • vaccine
  • dendritic cells
  • antigen-presenting cells
  • antigen presenting cells
  • cancer vaccine
  • PSA
  • prostatic adenocarcinoma
  • Neoplasms
  • Prostatic Neoplasms