Sipuleucel-T Based Autologous Cellular Immunotherapy for Advanced Prostate Cancer

Last updated: February 20, 2025
Sponsor: University of Oklahoma
Overall Status: Active - Recruiting

Phase

1

Condition

Prostate Cancer, Early, Recurrent

Prostate Disorders

Urologic Cancer

Treatment

Sipuleucel-T

Clinical Study ID

NCT05806814
OU-SCC-EXCITE
  • Ages > 18
  • Male

Study 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 Criteria

Inclusion

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 orminimally 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

Exclusion Criteria:

  1. Previously received Sipuleucel-T (Provenge®)

  2. Known malignancies other than prostate cancer likely to require treatment within 6months following registration

  3. A requirement for systemic immunosuppressive therapy (>10mg Prednisone daily orequivalent)

  4. A history of allergic reactions attributed to compounds of similar chemical orbiologic composition to Sipuleucel-T or GM-CSF

  5. Any infection requiring antibiotic therapy within 1 week prior to registration

Study Design

Total Participants: 13
Treatment Group(s): 1
Primary Treatment: Sipuleucel-T
Phase: 1
Study Start date:
November 12, 2023
Estimated Completion Date:
December 31, 2026

Study 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.

Connect with a study center

  • Stephenson's Cancer Center

    Oklahoma City, Oklahoma 73114
    United States

    Active - Recruiting

  • University of Oklahoma Health Sciences Center, Stephenson Cancer Center

    Oklahoma City, Oklahoma 73114
    United States

    Active - Recruiting

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