Sipuleucel-T Based Autologous Cellular Immunotherapy for Advanced Prostate Cancer
NCT ID: NCT05806814
Last Updated: 2025-02-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
13 participants
INTERVENTIONAL
2023-11-12
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Extended course of Sipuleucel-T treatment
Sipuleucel-T
Three doses of Sipuleucel-T, each containing a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF, given at week 0, 2, and 12-14.
Interventions
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Sipuleucel-T
Three doses of Sipuleucel-T, each containing a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF, given at week 0, 2, and 12-14.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Prostate cancer with history of metastasis
3. Candidates for Sipuleucel-T treatment are defined as those with asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
5. Life expectancy of ≥ 6 months
Exclusion Criteria
2. Known malignancies other than prostate cancer likely to require treatment within 6 months following registration
3. A requirement for systemic immunosuppressive therapy (\>10mg Prednisone daily or equivalent)
4. A history of allergic reactions attributed to compounds of similar chemical or biologic composition to Sipuleucel-T or GM-CSF
5. Any infection requiring antibiotic therapy within 1 week prior to registration
18 Years
MALE
No
Sponsors
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Dendreon
INDUSTRY
University of Oklahoma
OTHER
Responsible Party
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Principal Investigators
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Kelly Stratton, MD
Role: PRINCIPAL_INVESTIGATOR
Investigator
Locations
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University of Oklahoma Health Sciences Center, Stephenson Cancer Center
Oklahoma City, Oklahoma, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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OU-SCC-EXCITE
Identifier Type: -
Identifier Source: org_study_id
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