Ignite Creation Date:
2024-05-06 @ 6:42 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05751941
Status:
RECRUITING
Last Update Posted:
2024-01-26
First Post:
2023-02-21
Brief Title:
Study of Sipuleucel-T With or Without Continuing New Hormonal Agents in Metastatic Prostate Cancer
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
H Lee Moffitt Cancer Center and Research Institute
Study Overview
Official Title:
A Phase II Randomized Study of Sipuleucel-T With or Without Continuing New Hormonal Agents NHA in Metastatic Prostate Cancer With PSA Progression While on NHA and LHRH Analog
Status:
RECRUITING
Status Verified Date:
2024-08
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:
None
Brief 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
Detailed Description:
None
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