Ignite Creation Date:
2024-05-06 @ 6:51 PM
Last Modification Date:
2024-10-26 @ 2:55 PM
Study NCT ID:
NCT05806814
Status:
RECRUITING
Last Update Posted:
2024-06-11
First Post:
2023-03-28
Brief Title:
Sipuleucel-T Based Autologous Cellular Immunotherapy for Advanced Prostate Cancer
Sponsor:
University of Oklahoma
Organization:
University of Oklahoma
Study Overview
Official Title:
Pilot Trial to Investigate Immune Response to an Extended Course of Sipuleucel-T Immunotherapy in Patients With Metastatic Castration-resistant Prostate Cancer OU-SCC-EXCITE
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
OUSCCEXCITE
Brief Summary:
Proposed immunotherapy with an extended course of Sipuleucel-T treatment may induce a more robust immune response and improve the anti-cancer efficacy of Sipuleucel-T in patients with metastatic Castration-Resistant Prostate Cancer mCRPC
Detailed Description:
This open-label pilot trial aims to evaluate the feasibility of Sipuleucel-T given in three doses at weeks 0 2 and 12-14 and to investigate the changes in immune response in mCRPC patients who are getting an extended course of Sipuleucel-T treatment
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None