Sipuleucel-T Based Autologous Cellular Immunotherapy for Advanced Prostate Cancer (OUSCCEXCITE)

March 1, 2024 updated by: University of Oklahoma

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

Recruiting

Conditions

Intervention / Treatment

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 (Estimated)

12

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73114
        • Recruiting
        • Stephenson's Cancer Center
        • Contact:
        • Principal Investigator:
          • Kelly Stratton, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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.
Time Frame: 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.
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.
Time Frame: 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.
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.
Time Frame: 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.
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.
Time Frame: 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.
up to 12 Months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oklahoma

Collaborators

Dendreon

Investigators

  • Principal Investigator: Kelly Stratton, MD, Investigator

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 12, 2023

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

May 1, 2024

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 (Estimated)

March 4, 2024

Last Update Submitted That Met QC Criteria

March 1, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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