Immunotherapy using Sipuleucel-T for advanced prostate cancer
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)
PHASE1 · University of Oklahoma · NCT05806814
This study is testing if giving three doses of a new immune therapy called Sipuleucel-T can help improve the health of men with advanced prostate cancer that doesn't respond to hormone treatment.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 13 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | University of Oklahoma (other) |
| Drugs / interventions | Prednisone, immunotherapy |
| Locations | 1 site (Oklahoma City, Oklahoma) |
| Trial ID | NCT05806814 on ClinicalTrials.gov |
What this trial studies
This pilot trial investigates the feasibility of administering Sipuleucel-T, an autologous cellular immunotherapy, in three doses to patients with metastatic castration-resistant prostate cancer (mCRPC). The treatment is designed to enhance the immune response against cancer by utilizing antigen presenting cells. Participants will receive doses at weeks 0, 2, and 12-14, and the study will monitor changes in immune response and treatment efficacy. The trial aims to determine if an extended course of Sipuleucel-T can improve outcomes for these patients.
Who should consider this trial
Good fit: Ideal candidates are men aged 18 and older with asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer.
Not a fit: Patients who have previously received Sipuleucel-T or have other malignancies requiring treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more effective immunotherapy option for patients with advanced prostate cancer.
How similar studies have performed: Other studies have shown promise with Sipuleucel-T, but this specific approach of extended dosing is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Oklahoma City, Oklahoma
- University of Oklahoma Health Sciences Center, Stephenson Cancer Center — Oklahoma City, Oklahoma, United States (RECRUITING)
Study contacts
- Principal investigator: Kelly Stratton, MD — Investigator
- Study coordinator: Lead Onco Nurse
- Email: SCCIITOffice@ouhsc.edu
- Phone: 405-271-8777
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Metastatic Castration-Resistant Prostate Cancer, antigen presenting cells, Sipuleucel-T, granulocyte-macrophage colony-stimulating factor, prostatic acid phosphatase