Therapy Detail
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| Therapy Name | Sipuleucel-T |
| Synonyms | |
| Therapy Description |
Provenge (sipuleucel-T) is composed of autologous dendritic cells exposed to a PAP-GCSF fusion protein (PA2024), which stimulates a cytotoxic immune response towards PAP-expressing tumor cells (PMID: 25565923, PMID: 25708576). Provenge (sipuleucel-T) is FDA-approved for use in patients with metastatic castration-resistant prostate cancer (FDA.gov). |
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| Drug Name | Trade Name | Synonyms | Drug Classes | Drug Description |
|---|---|---|---|---|
| Sipuleucel-T | Provenge | APC 8015 | Provenge (sipuleucel-T) is composed of autologous dendritic cells exposed to a PAP-GCSF fusion protein (PA2024), which stimulates a cytotoxic immune response towards PAP-expressing tumor cells (PMID: 25565923, PMID: 25708576). Provenge (sipuleucel-T) is FDA-approved for use in patients with metastatic castration-resistant prostate cancer (FDA.gov). |
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| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|
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| Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
|---|---|---|---|---|---|---|
| NCT02036918 | Phase I | Sipuleucel-T | Dendreon Lymph Node Biopsy in Metastatic Castrate-Resistant Prostate Cancer | Completed | USA | 0 |
| NCT05806814 | Phase I | Sipuleucel-T | Sipuleucel-T Based Autologous Cellular Immunotherapy for Advanced Prostate Cancer | Recruiting | USA | 0 |
| NCT02353715 | Phase I | Abiraterone Enzalutamide Sipuleucel-T | Men With Metastatic Castrate-Resistant Prostate Cancer Treated With Either Sipuleucel-T (Provenge), Abiraterone Acetate (Zytiga) or Enzalutamide (Xtandi) Undergoing Cardiopulmonary EXercise Testing | Completed | USA | 0 |
| NCT02463799 | Phase II | Radium Ra 223 dichloride Sipuleucel-T | Ph 2 Study of Sipuleucel-T W/ or W/O Radium-223 in Men With Asymptomatic or Minimally Symptomatic Bone-MCRPC | Completed | USA | 0 |
| NCT02159950 | Phase II | Sipuleucel-T Tasquinimod | Sipuleucel-T With or Without Tasquinimod in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer | Completed | USA | 0 |
| NCT05751941 | Phase II | Sipuleucel-T Abiraterone + Sipuleucel-T Apalutamide + Sipuleucel-T Enzalutamide + Sipuleucel-T | Study of Sipuleucel-T With or Without Continuing New Hormonal Agents in Metastatic Prostate Cancer | Recruiting | USA | 0 |
| NCT01807065 | Phase II | Sipuleucel-T | Sipuleucel-T With or Without Radiation Therapy in Treating Patients With Hormone-Resistant Metastatic Prostate Cancer | Completed | USA | 0 |
| NCT01818986 | Phase II | Sipuleucel-T | Sipuleucel-T and Stereotactic Ablative Body Radiation (SABR) for Metastatic Castrate-resistant Prostate Cancer (mCRPC) | Completed | USA | 0 |
| NCT03686683 | Phase III | Sipuleucel-T | Open- Label Trial of Sipuleucel-T Administered to Active Surveillance Patients for Newly Diagnosed Prostate Cancer (ProVent) | Completed | USA | 0 |
| NCT01560923 | Phase II | Sipuleucel-T | Phase II Study of Sipuleucel-T and Indoximod for Patients With Refractory Metastatic Prostate Cancer | Completed | USA | 0 |
| NCT01706458 | Phase II | pTVG-HP plasmid DNA vaccine Sipuleucel-T | Provenge With or Without pTVG-HP DNA Booster Vaccine in Prostate Cancer | Completed | USA | 0 |
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