Clinical trial · Interventional
Sipuleucel-T in Metastatic Castrate Resistant Prostate Cancer
An Open-Label Multicenter Study of Sipuleucel-T in Metastatic Castrate Resistant Prostate Cancer Patients Previously Treated With Sipuleucel-T on Dendreon Study P-11 (NCT00779402)
NCT01338012CI-TRIAL-00027972mCRPCterminatedPhase 2Results 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)
Multicenter open label, uncontrolled study that enrolled men with metastatic castrate resistant prostate cancer previously treated with sipuleucel-T in the androgen dependent setting in the Dendreon P-11 study. The study was divided into Active and Long Term Follow-up (LTFU) Phases.
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)
- type
- EXPERIMENTAL
- label
- sipuleucel-T
- description
- Men with metastatic castrate resistant prostate cancer previously treated with sipuleucel-T in the androgen dependent setting in the Dendreon P-11 study. Subjects received one infusion of sipuleucel-T every two weeks for for a total of three infusions.
- interventionNames
- Biological: sipuleucel-T
Primary outcomes (1)
- measure
- Number of Study Participants Enrolled and Treated Prior to Study Termination
- timeFrame
- Study duration: date of first subject registration Dec 2011 and date of last subject visit April 2015
- description
- Number of study participants that were enrolled and treated in this trial following completion of study P-11 and prior to study termination.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Previously randomized in Dendreon's P-11 study (NCT00779402) and received at least one infusion of sipuleucel-T * Radiologic evidence of metastasis * Castrate resistant prostate cancer. Subjects must have current or historical evidence of disease progression concomitant with surgical or medical castration, as demonstrated by PSA progression OR progression of measurable disease OR progression of non-measurable disease * Castrate level of testosterone (\< 50 ng/dL) achieved via medical or surgical castration * Adequate hematologic function Exclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status \> 2 * Treatment with chemotherapy within 3 months prior to registration * Treatment with systemic corticosteroids, abiraterone acetate, external beam radiation therapy, or any investigational product for prostate cancer within 28 days prior to registration * Treatment with commercial sipuleucel-T (Provenge®) * Current or imminent pathologic long-bone fracture or spinal cord compression * Known malignancies other than prostate cancer likely to require treatment within 6 months following registration * A requirement for systemic immunosuppressive therapy for any reason * A history of allergic reactions attributed to compounds of similar chemical or biologic composition to sipuleucel-T or GM-CSF * Any infection requiring antibiotic therapy or causing fever within 1 week prior to registration * Any surgery requiring general anesthetic within 28 days prior to registration
References
Publications (0)
Data not yet available
No reference posted for this study.