Sipuleucel-T Based Autologous Cellular Immunotherapy for Advanced Prostate Cancer (OU-SCC-EXCITE)

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)

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Metastatic Castration-Resistant Prostate Cancer (mCRPC)
• Intervention / Treatment: Biological: Sipuleucel-T

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 Type: Interventional
• Enrollment (Actual): 15
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73114
      • University of Oklahoma Health Sciences Center, Stephenson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Extended course of Sipuleucel-T treatment	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.; Other Names: PROVENGE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of patients completing 3 doses of Sipuleucel-T immunotherapy.	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.	up to 5 months
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.	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.	up to 12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the mean difference in immune response to Sipuleucel-T treatment among different racial groups.	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.	up to 12 months
Evaluate the potential tumor response based on the changes in serum PSA at baseline and within 30 days of last dose.	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.	up to 12 Months

Collaborators and Investigators

• Sponsor: University of Oklahoma
• Collaborators: Dendreon
• Investigators: Principal Investigator: Kelly Stratton, MD, Investigator

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2023
• Primary Completion (Actual): May 13, 2026
• Study Completion (Estimated): May 13, 2028

Study Registration Dates

• First Submitted: March 28, 2023
• First Submitted That Met QC Criteria: March 28, 2023
• First Posted (Actual): April 10, 2023

Study Record Updates

• Last Update Posted (Actual): May 27, 2026
• Last Update Submitted That Met QC Criteria: May 26, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: granulocyte-macrophage colony-stimulating factor (GM-CSF); antigen presenting cells (APCs); Sipuleucel-T (Sip-T); prostatic acid phosphatase (PAP)
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Prostatic Diseases; Male Urogenital Diseases; Prostatic Neoplasms; sipuleucel-T
• Other Study ID Numbers: OU-SCC-EXCITE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes