Clinical trial · Interventional
Immunotherapy With APC8015 (Sipuleucel-T, Provenge) for Asymptomatic, Metastatic, Hormone-Refractory Prostate Cancer
A Randomized, Double Blind, Placebo Controlled Trial of Immunotherapy With Autologous Antigen-Loaded Dendritic Cells (Provenge®, APC8015) for Asymptomatic, Metastatic, Hormone-Refractory Prostate Cancer
NCT01133704CI-TRIAL-00003889completedPhase 3Results 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 randomized, double blind, placebo controlled trial of immunotherapy with autologous antigen-loaded dendritic cells (Provenge, APC8015) for asymptomatic, metastatic, hormone-refractory prostate cancer.
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 |
|---|---|---|---|
| Hormone-Refractory Prostate Cancer | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| APC-Placebo | Biological | — | UNRESOLVED |
| sipuleucel-T | Biological | Autologous peripheral-blood mononuclear cells activated with prostatic acid phosphatase granulocyte-macrophage colony-stimulating factor | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- sipuleucel-T (APC8015)
- interventionNames
- Biological: sipuleucel-T
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- interventionNames
- Biological: APC-Placebo
Primary outcomes (1)
- measure
- Overall Time to Disease Progression
- timeFrame
- from randomization to 36 months
- description
- Overall time to disease progression in subjects with asymptomatic metastatic hormone-refractory prostate cancer treated with sipuleucel-T (APC8015) compared to overall time to disease progression in subjects treated with placebo.
Secondary outcomes (1)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically documented adenocarcinoma of the prostate * Metastatic disease as evidenced by soft tissue and/or bony metastases * Prostate-specific antigen value of at least 5 ng/mL * Tumor progression while on hormonal therapy * Castration levels of testosterone (defined as less than 50 ng/dL) * Life expectancy of at least 16 weeks * Adequate hematologic, renal, and liver function Exclusion Criteria: * Visceral organ metastases * Metastatic disease expected to be in need of radiation therapy within 4 months. * Concurrent therapy with experimental agents
References
Publications (2)
- DERIVEDJu M, Fan J, Zou Y, Yu M, Jiang L, Wei Q, Bi J, Hu B, Guan Q, Song X, Dong M, Wang L, Yu L, Wang Y, Kang H, Xin W, Zhao L. Computational Recognition of a Regulatory T-cell-specific Signature With Potential Implications in Prognosis, Immunotherapy, and Therapeutic Resistance of Prostate Cancer. Front Immunol. 2022 Jun 23;13:807840. doi: 10.3389/fimmu.2022.807840. eCollection 2022. PMID 35812443
- DERIVEDSmall EJ, Higano CS, Kantoff PW, Whitmore JB, Frohlich MW, Petrylak DP. Time to disease-related pain and first opioid use in patients with metastatic castration-resistant prostate cancer treated with sipuleucel-T. Prostate Cancer Prostatic Dis. 2014 Sep;17(3):259-64. doi: 10.1038/pcan.2014.21. Epub 2014 Jun 24. PMID 24957547