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Active, Not Recruiting

NCT Number: NCT05806814

Sipuleucel-T Based Autologous Cellular Immunotherapy for Advanced Prostate Cancer

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).

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Metastatic Castration-resistant Prostate Cancer (mCRPC)

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

University of Oklahoma Health Sciences Center, Stephenson Cancer Center

Oklahoma City, Oklahoma, 73114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: PROVENGE

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

University of Oklahoma

Other

Collaborators

  • Dendreon

Registry information

Official study title

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)

Acronym: OU-SCC-EXCITE

Important dates

Study start
2023
Primary completion
2026
Study completion
2028
First posted
Apr 10, 2023
Registry last updated
May 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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