Clinical trial · Interventional
Sipuleucel-T Based Autologous Cellular Immunotherapy 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)
NCT05806814CI-TRIAL-00112678OU-SCC-EXCITEactive not recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Castration-Resistant Prostate Cancer (mCRPC) | Castration-Resistant Prostate Carcinoma | CURATED_BROADER | 0.78 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Sipuleucel-T | Biological | Autologous peripheral-blood mononuclear cells activated with prostatic acid phosphatase granulocyte-macrophage colony-stimulating factor | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Extended course of Sipuleucel-T treatment
- interventionNames
- Biological: Sipuleucel-T
Primary outcomes (2)
- measure
- Proportion of patients completing 3 doses of Sipuleucel-T immunotherapy.
- timeFrame
- up to 5 months
- description
- 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.
- measure
- 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.
- timeFrame
- up to 12 Months
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.