drugset / Trial / NCT05751941
Study of Sipuleucel-T With or Without Continuing New Hormonal Agents in Metastatic Prostate Cancer
Phase 2
Active not recruiting
26 enrolled
H. Lee Moffitt Cancer Center and Research Institute
Dendreon · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This study is designed to test the hypothesis that using Sipuleucel-T (Provenge) in combination with new hormonal agents (NHA) (abiraterone, enzalutamide, apalutamide) for the treatment of participants with asymptomatic metastatic castration resistant prostate cancer (mCRPC) and no visceral metastases would enhance the activation of antigen presenting cells (APC) by sipuleucel-T.
Timeline
- Start
- 2023-02-14
- Primary completion
- 2026-07
- Completion
- 2026-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Abiraterone acetate | Small molecule | 1000 mg | Oral |
| Subject | Apalutamide | Small molecule | 240 mg | Oral |
| Subject | Enzalutamide | Other / unclassified | 160 mg | Oral |
| Background | Sipuleucel-T | Cell therapy | — | — |