Sipuleucel-T Based Autologous Cellular Immunotherapy for Advanced Prostate Cancer

Running, not enrolling · Phase 1

Conditions studied: Metastatic Castration-Resistant Prostate Cancer (mCRPC)

In brief

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).

Key facts

Study ID

NCT05806814

Run by

University of Oklahoma

People needed

15

Starts

2023-11-12

Expected to finish

2028-05-13

Last updated by the study team

2026-05-27

Who can join

Age: 18 and older. Sex: male. Healthy volunteers: not accepted.

You may qualify if…

• Men ≥ 18 years of age
• Prostate cancer with history of metastasis
• Candidates for Sipuleucel-T treatment are defined as those with asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Life expectancy of ≥ 6 months

You may not qualify if…

• Previously received Sipuleucel-T (Provenge®)
• Known malignancies other than prostate cancer likely to require treatment within 6 months following registration
• A requirement for systemic immunosuppressive therapy (>10mg Prednisone daily or equivalent)
• A history of allergic reactions attributed to compounds of similar chemical or biologic composition to Sipuleucel-T or GM-CSF
• Any infection requiring antibiotic therapy within 1 week prior to registration

Where it is running

• University of Oklahoma Health Sciences Center, Stephenson Cancer Center — Oklahoma City, Oklahoma, United States

Full record on ClinicalTrials.gov

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