Sipuleucel-T Based Autologous Cellular Immunotherapy for Advanced Prostate Cancer
Status
RECRUITING
Phase
PHASE1
Age
≥ 18 Years
Enrollments
13
Conditions
Metastatic Castration-Resistant Prostate Cancer (mCRPC)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.
Locations
1 location Found with status Recruiting
Status
- RECRUITING
Contact Person
- Kelly Stratton, MD
- 405-271-6900
- [email protected]
Principal Investigator
- Kelly Stratton, MD
Eligibility Criteria
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
Study Plan
Extended course of Sipuleucel-T treatment
-
BIOLOGICAL:
Sipuleucel-TDescription:
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.
Outcome Measures
Primary Outcome Measures
Proportion of patients completing 3 doses of Sipuleucel-T immunotherapy.
Proportion of subjects who have detectable elevated IgG level and/or T-cell proliferation from baseline to the follow-up of extended course of Sipuleucel-T immunotherapy.
Secondary Outcome Measures
Evaluate the mean difference in immune response to Sipuleucel-T treatment among different racial groups.
Evaluate the potential tumor response based on the changes in serum PSA at baseline and within 30 days of last dose.
Timeline
-
Last Updated
February 24, 2025 -
Start Date
April 10, 2023 -
Today
May 15, 2025 -
Completion Date ( Estimated )
December 1, 2026
Sponsors of this trial
-
Lead Sponsor
University of Oklahoma -
Collaborating Sponsors
Dendreon
RECRUITING 
≥ 18 Years