Clinical trial · Observational
Immune Monitoring Protocol in Men With Prostate Cancer Enrolled in a Clinical Trial of Sipuleucel-T
NCT01727154CI-TRIAL-00040127PRIMEterminatedResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Administrative reasons
Summary
Brief summary (as posted)
The purpose of this study is to evaluate the immune response induced by sipuleucel-T (Provenge®).
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 (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)
- label
- Sipuleucel-T
- interventionNames
- Biological: Sipuleucel-T
Primary outcomes (1)
- measure
- The Percentage of Subjects Who Exhibit Any Immune Response at Any Post-treatment Time Point (6, 10, 14, 26, 39, and 52 Weeks After the First Infusion of Sipuleucel-T).
- timeFrame
- Each subjects was to be followed for approximately 52 weeks beginning with the date of the subject's first infusion of siupleucel-T.
- description
- The primary immune response analysis population will include all subjects who receive all 3 infusions of sipuleucel-T. The primary analysis will measure the percentage of subjects who exhibit any immune response at any post-treatment time point (6, 10, 14, 26, 39, and 52 weeks after the first infusion of sipuleucel-T).
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Subjects must be at least 18 years of age * Subjects with prostate cancer who are enrolled in a clinical trial of sipuleucel-T (including a Dendreon-sponsored clinical trial or registry, or an IIT) * Subjects have not yet undergone leukapheresis for their first dose of sipuleucel-T * Subjects must understand and sign an informed consent form prior to their first leukapheresis Exclusion Criteria: •None
References
Publications (0)
Data not yet available
No reference posted for this study.