Sipuleucel-T Based Autologous Cellular Immunotherapy for Advanced Prostate Cancer

Phase 1

Recruiting

• Conditions: Metastatic Castration-Resistant Prostate Cancer (mCRPC)
• Interventions: Biological: Sipuleucel-T

• Registration Number: NCT05806814
• Lead Sponsor: University of Oklahoma

Brief 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.

Study Timeline

• Study First Submitted: 2023-03-28
• Study First Submitted QC: 2023-03-28
• Study First Posted: 2023-04-10
• Study Start: 2023-11-12
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-20
• Last Update Posted: 2025-02-24
• Primary Completion: 2026-06
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 13

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Extended course of Sipuleucel-T treatment	Sipuleucel-T	-

Primary Outcome Measures

Name	Time	Method
Proportion of patients completing 3 doses of Sipuleucel-T immunotherapy.	up to 5 months	Patients will be treated with Sipuleucel-T immunotherapy and the treatment regimen will be considered feasible if 85% of enrolled patients complete all three infusions of Sipuleucel-T treatment given at week 0, 2 and 12-14.
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.	up to 12 Months	For patients undergoing Sipuleucel-T treatment on weeks 0, 2 and 12-14, the changes in immune response will be measured based on the detectable elevated levels of IgG and/or T-cell proliferation against various types of prostate cancer associated antigens at baseline, and at Sipuleucel-T infusion doses given at week 0, 2 and 12-14 weeks.

Secondary Outcome Measures

Name	Time	Method
Evaluate the potential tumor response based on the changes in serum PSA at baseline and within 30 days of last dose.	up to 12 Months	For patients undergoing Sipuleucel-T treatment on weeks 0, 2 and 12-14, the preliminary tumor response will be measure through the comparison of serum PSA level between baseline and within 30 days of last dose.
Evaluate the mean difference in immune response to Sipuleucel-T treatment among different racial groups.	up to 12 months	Potential difference of immune response to Sipuleucel-T immunotherapy given at weeks 0, 2 and 12-14 will be compared in patients with mCRPC of different racial groups using the one-way ANOVA or the Kruskal-Wallis test.

Trial Locations

Locations (1)

University of Oklahoma Health Sciences Center, Stephenson Cancer Center; 🇺🇸 Oklahoma City, Oklahoma, United States