NCT05806814

Sipuleucel-T Based Autologous Cellular Immunotherapy for Advanced Prostate Cancer

Pilot Trial to Investigate Immune Response to an Extended Course of Sipuleucel-T Immunotherapy in Patients With Metastatic Castration-resistant Prostate Cancer (OU-SCC-EXCITE)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 13 (estimated)
• Sponsor: University of Oklahoma · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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).

Detailed description

This open-label, pilot trial aims to evaluate the feasibility of Sipuleucel-T given in three doses at weeks 0, 2, and 12-14; and to investigate the changes in immune response in mCRPC patients who are getting an extended course of Sipuleucel-T treatment.

Conditions

• Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Interventions

Type	Name	Description
BIOLOGICAL	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.

Timeline

• Start date: 2023-11-12
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2023-04-10
• Last updated: 2026-03-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study