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Sipuleucel-T Based Autologous Cellular Immunotherapy for Advanced Prostate Cancer

RECRUITINGPhase 1Sponsored by University of Oklahoma
Actively Recruiting
PhasePhase 1
SponsorUniversity of Oklahoma
Started2023-11-12
Est. completion2026-06
Eligibility
Age18 Years+
SexMALE
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →

NCT05806814

Summary

Proposed immunotherapy with an extended course of Sipuleucel-T treatment may induce a more robust immune response and improve the anti-cancer efficacy of Sipuleucel-T in patients with metastatic Castration-Resistant Prostate Cancer (mCRPC).

Eligibility

Age: 18 Years+Sex: MALEHealthy volunteers accepted
Inclusion Criteria:

1. Men ≥ 18 years of age
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:

1. Previously received Sipuleucel-T (Provenge®)
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

Conditions2

CancerMetastatic Castration-resistant Prostate Cancer, mCRPC

Locations1 site

University of Oklahoma Health Sciences Center, Stephenson Cancer Center
Oklahoma City, Oklahoma, 73114
Kelly Stratton, MD405-271-6900Kelly-Stratton@ouhsc.edu

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