Immunotherapy With APC8015 (Sipuleucel-T, Provenge) for Asymptomatic, Metastatic, Hormone-Refractory Prostate Cancer
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ClinicalTrials.gov Identifier: NCT01133704 |
Recruitment Status :
Completed
First Posted : May 31, 2010
Results First Posted : September 2, 2010
Last Update Posted : September 8, 2010
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Hormone-Refractory Prostate Cancer |
Interventions |
Biological: sipuleucel-T Biological: APC-Placebo |
Enrollment | 98 |
Recruitment Details | Participants were randomized between May 2000 and March 2003 across 24 clinical trial sites. |
Pre-assignment Details | Participants were screened for evaluation of subject eligibility and performance of baseline tests/procedures. |
Arm/Group Title | Sipuleucel-T (APC8015) | Placebo |
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All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart. |
All subjects randomized to receive placebo. Approximately one-third of the autologous quiescent APCs prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals. |
Period Title: Overall Study | ||
Started | 65 | 33 |
Completed | 16 [1] | 7 [1] |
Not Completed | 49 | 26 |
Reason Not Completed | ||
Death | 44 | 26 |
Patient refused to continue | 4 | 0 |
Study Closure | 1 | 0 |
[1]
(including 3 year follow-up)
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Arm/Group Title | Sipuleucel-T (APC8015) | Placebo | Total | |
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All subjects randomized to receive sipuleucel-T. Autologous peripheral blood mononuclear cells, including antigen presenting cells, that have been activated in vitro with a recombinant fusion protein, PAP-GM-CSF. Treatment consist of 3 doses administered approximately 2 weeks apart. |
All subjects randomized to receive placebo. Approximately one-third of the autologous quiescent APCs prepared from a single leukapheresis procedure. A course of therapy consists of 3 complete doses given at approximately 2-week intervals. |
Total of all reporting groups | |
Overall Number of Baseline Participants | 65 | 33 | 98 | |
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[Not Specified]
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Age Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 65 participants | 33 participants | 98 participants | |
69.6 (8.2) | 70.6 (7.8) | 69.9 (8.1) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 65 participants | 33 participants | 98 participants | |
Female |
0 0.0%
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0 0.0%
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0 0.0%
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Male |
65 100.0%
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33 100.0%
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98 100.0%
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Name/Title: | Kathleen Picha |
Organization: | Dendreon Corporation |
Phone: | 206-265-4545 |
EMail: | kpicha@dendreon.com |
ClinicalTrials.gov Identifier: | NCT01133704 |
Other Study ID Numbers: |
D9902A |
First Submitted: | May 27, 2010 |
First Posted: | May 31, 2010 |
Results First Submitted: | June 1, 2010 |
Results First Posted: | September 2, 2010 |
Last Update Posted: | September 8, 2010 |