Sipuleucel-T Based Autologous Cellular Immunotherapy for Advanced Prostate Cancer

NCT05806814 | Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: OU-SCC-EXCITE
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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).

Conditions

Metastatic Castration-Resistant Prostate Cancer (mCRPC)

Keywords

antigen presenting cells (APCs); Sipuleucel-T (Sip-T); granulocyte-macrophage colony-stimulating factor (GM-CSF); prostatic acid phosphatase (PAP)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Evaluate the mean difference in immune response to Sipuleucel-T treatment among different racial groups.

  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.

  up to 12 Months

Study Arms (1)

Extended course of Sipuleucel-T treatment

EXPERIMENTAL

Biological: Sipuleucel-T

Interventions

Sipuleucel-T BIOLOGICAL

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.

Also known as: PROVENGE

Extended course of Sipuleucel-T treatment

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: The study is focused on a prostate cancer-specific group.
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Men ≥ 18 years of age
• Prostate cancer with history of metastasis
• Candidates for Sipuleucel-T treatment are defined as those with asymptomatic or minimally symptomatic metastatic castrate resistant prostate cancer
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
• Life expectancy of ≥ 6 months

You may not qualify if:

• Previously received Sipuleucel-T (Provenge®)
• Known malignancies other than prostate cancer likely to require treatment within 6 months following registration
• A requirement for systemic immunosuppressive therapy (\>10mg Prednisone daily or equivalent)
• A history of allergic reactions attributed to compounds of similar chemical or biologic composition to Sipuleucel-T or GM-CSF
• Any infection requiring antibiotic therapy within 1 week prior to registration

Sponsors & Collaborators

• University of Oklahoma: lead
• Dendreon: collaborator

Study Sites (1)

University of Oklahoma Health Sciences Center, Stephenson Cancer Center

Oklahoma City, Oklahoma, 73114, United States

RECRUITING

MeSH Terms

Interventions

sipuleucel-T

Study Officials

• Kelly Stratton, MD

  Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lead Onco Nurse

CONTACT

405-271-8777; SCCIITOffice@ouhsc.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: The primary objective is to evaluate the feasibility and immune response of an extended course of Sipuleucel-T immunotherapy given at week 0, 2, and 12-14 in patients with metastatic castration-resistant prostate cancer.

Study Record Dates

• First Submitted: March 28, 2023
• First Posted: April 10, 2023
• Study Start: November 12, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 5, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)