Sipuleucel-T Based Autologous Cellular Immunotherapy for Advanced Prostate Cancer
Launched by UNIVERSITY OF OKLAHOMA · Mar 28, 2023
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a new approach to treating advanced prostate cancer, specifically a type called metastatic castration-resistant prostate cancer (mCRPC). Researchers are looking at a treatment called Sipuleucel-T, which is an immunotherapy designed to help the body's immune system fight cancer. In this trial, participants will receive an extended course of Sipuleucel-T to see if it can create a stronger immune response against the cancer, potentially improving treatment outcomes.
Men aged 18 and older with prostate cancer that has spread and is showing minimal symptoms may be eligible to join the study. To qualify, participants should have a good performance status, meaning they can carry out daily activities without much difficulty, and should expect to live for at least six more months. However, those who have previously received Sipuleucel-T or have other serious health conditions may not be eligible. If you decide to participate, you can expect to receive this experimental treatment and be closely monitored by the research team to assess its effectiveness and safety.
Gender
MALE
Eligibility criteria
- 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
About University Of Oklahoma
The University of Oklahoma, a leading research institution, is dedicated to advancing healthcare through innovative clinical trials and research initiatives. With a robust network of interdisciplinary experts and state-of-the-art facilities, the university fosters an environment that promotes scientific discovery and the development of new treatments. Its commitment to patient-centered research ensures that clinical trials not only adhere to the highest ethical standards but also aim to address pressing health challenges. By collaborating with various stakeholders, including industry partners and healthcare providers, the University of Oklahoma seeks to translate research findings into tangible benefits for communities, ultimately enhancing the quality of care and improving health outcomes.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Oklahoma City, Oklahoma, United States
Oklahoma City, Oklahoma, United States
Patients applied
Trial Officials
Kelly Stratton, MD
Principal Investigator
Investigator
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
Similar Trials