Clinical trial · Interventional
Open Label Study of Sipuleucel-T in Metastatic Prostate Cancer
An Open Label Study of Sipuleucel-T in Men With Metastatic Castrate Resistant Prostate Cancer
NCT00901342CI-TRIAL-00027749completedPhase 2Results postedClinicalTrials.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)
This is a Multicenter, Open Label, Phase 2 Study of Sipuleucel-T in Men with Metastatic Castrate Resistant Prostate Cancer (CRPC).
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
- Subjects received infusion of sipuleucel-T, at 2-week intervals, for a total of 3 infusions.
- interventionNames
- Biological: sipuleucel-T
Primary outcomes (1)
- measure
- Number of Participants Who Received At Least 1 Infusion of Sipuleucel-T in Men With Metastatic Castrate-resistant Prostate Cancer (CRPC)
- timeFrame
- Day 0 (first infusion) and up to 3 infusions at 2-week intervals
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically documented adenocarcinoma of the prostate * Metastatic disease * Castrate resistant prostate cancer * Castrate level of testosterone (\< 50 ng/dL) achieved via medical or surgical castration * Life expectancy of ≥ 3 months * Men ≥ 18 years of age * Adequate hematologic, renal and liver function Exclusion Criteria: * Presence of known lung, liver, or brain metastases * Evidence of neuroendocrine or small cell features * Eastern Cooperative Oncology Group (ECOG) performance status \> 2 * Prior treatment with 3 infusions of sipuleucel-T (infusions of APC8015F are not exclusionary) * Imminent pathologic long-bone fracture (cortical erosion on radiography \> 50%) or spinal cord compression * Known malignancies other than prostate cancer that are likely to require treatment within six months of 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 granulocyte-macrophage colony-stimulating factor * Any infection requiring parenteral antibiotic therapy or causing fever (temp \> 100.5F or \> 38.1C) within 1 week prior to registration * Any medical intervention or other condition which, in the opinion of the Principal Investigator or the Dendreon Medical Monitor, could compromise adherence with study requirements or otherwise compromise the study's objectives Treatment with any of the following medications or interventions within 28 days of registration: * Systemic corticosteroids. Use of inhaled, intranasal, intra-articular, and topical steroids is acceptable, as is a short course (ie, ≤ 1 day) of corticosteroids to prevent a reaction to the IV contrast used for CT scans * Non-steroidal anti-androgens (eg, bicalutamide, flutamide, or nilutamide) * External beam radiation therapy or major surgery requiring general anesthetic * Any other systemic therapy for prostate cancer including secondary hormonal therapies, such as megestrol acetate (Megace®), diethylstilbestrol (DES), and ketoconazole. Medical castration therapy is not exclusionary * Chemotherapy * Treatment with any other investigational product
References
Publications (0)
Data not yet available
No reference posted for this study.