Sipuleucel-T Combined With Bipolar Androgen Therapy in Men With mCRPC - Trial NCT06100705
Access comprehensive clinical trial information for NCT06100705 through Pure Global AI's free database. This Phase 2 trial is sponsored by Yale University and is currently Not yet recruiting. The study focuses on Metastatic Castration-resistant Prostate Cancer. Target enrollment is 26 participants.
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Study Focus
Sponsor & Location
Yale University
Timeline & Enrollment
Phase 2
Nov 01, 2023
Mar 01, 2028
Primary Outcome
To determine the immune response to PA2024 with BAT and Sipuleucel-T
Summary
This is an open-label, single-arm phase II study of bipolar androgen therapy (BAT) given in
 addition with standard of care Sipuleucel-T to determine the interferon (IFN) gamma
 Enzyme-linked Immunospot (ELISPOT) response rate to PA2024 (an engineered fusion protein of
 prostatic acid phosphatase and granulocyte-macrophage colony-stimulating factor which the
 activated autologous dendritic cells in the Sipuleucel-T vaccine are loaded with) in patients
 with metastatic castration resistant prostate cancer (mCRPC).
ICD-10 Classifications
Data Source
ClinicalTrials.gov
NCT06100705
Non-Device Trial