Sipuleucel-T Based Autologous Cellular Immunotherapy for Advanced Prostate Cancer

Description

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)

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Study Overview

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Study Details

Study overview

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).

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)

Sipuleucel-T Based Autologous Cellular Immunotherapy for Advanced Prostate Cancer

Condition
Metastatic Castration-Resistant Prostate Cancer (mCRPC)
Intervention / Treatment

-

Contacts and Locations

Oklahoma City

Stephenson's Cancer Center, Oklahoma City, Oklahoma, United States, 73114

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

MALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Oklahoma,

Kelly Stratton, MD, PRINCIPAL_INVESTIGATOR, Investigator

Study Record Dates

2024-11