Clinical trial · Observational
Immune Monitoring on Sipuleucel-T
A Systems Biology Approach to Immune Monitoring in Patients With Castration-resistant Prostate Cancer Receiving SiPuleucel-T
NCT02237170CI-TRIAL-00025347PROVENGEcompletedClinicalTrials.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)
The purpose of this protocol is perform comprehensive immune monitoring studies in patients with castration-resistant prostate cancer receiving Sipuleucel-T in an effort to better understand the mechanism of action of this treatment.
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 |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Castration Resistant Metastatic Prostate Cancer
- description
- Castration Resistant Metastatic Prostate Cancer with no history of prior systemic chemotherapy
Primary outcomes (1)
- measure
- Change in Regulatory T cells (Tregs)
- timeFrame
- baseline and 1 year
- description
- Establish the phenotype and frequency of circulating immune cell compartments in patients undergoing treatment with Sipuleucel-T looking at the change in regulatory T cells at 1 year post treatment compared to at baseline
Secondary outcomes (6)
- measure
- Change in Antigen Presenting Cells
- timeFrame
- baseline and 1 year
- description
- Establish the phenotype and frequency of circulating immune cell compartments in patients undergoing treatment with Sipuleucel-T looking at the change in antigen presenting cells: DCs and B cells at 1 year post treatment compared to at baseline
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Age \> 18 years of age * Written informed consent obtained * Patients with castration-resistant prostate cancer who are initiating Sipuleucel-T as standard therapy * No prior systemic chemotherapy for metastatic prostate cancer * Hemoglobin \> 9 mg/dl Exclusion Criteria: * Patients unable to understand the research protocol and/or provide informed consent
References
Publications (0)
Data not yet available
No reference posted for this study.