To demonstrate that sipuleucel-T can be successfully manufactured for subjects with
metastatic castrate resistant prostate cancer (mCRPC) at a European manufacturing facility.
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
registration
- 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
(Xgeva[TM])
- 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
registration:
- 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.
