Ignite Creation Date:
2025-12-24 @ 9:41 PM
Ignite Modification Date:
2025-12-28 @ 11:48 PM
Study NCT ID:
NCT06134232
Status:
RECRUITING
Last Update Posted:
2025-08-27
First Post:
2023-10-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Metastatic Castrate-Resistant Prostate Cancer Subjects Treated With PROVENGE® + One Infusion of Sipuleucel-T
Sponsor:
Dendreon
Organization:
Study Overview
Official Title:
An Open -Label, Multicenter Study of Subjects With Metastatic Castrate-Resistant Prostate Cancer Treated With PROVENGE ® and Boosted With A Single Infusion of Sipuleucel-T to Measure Immune Response
Status:
RECRUITING
Status Verified Date:
2025-08
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:
ProvONE
Brief Summary:
A multicenter, open-label, prospective study to investigate immune boost response changes in patients with metastatic castrate-resistant prostate cancer (mCRPC).
Detailed Description:
Those enrolled in the Booster Study will have had their course of treatment with PROVENGE® immunotherapy and then randomized to the Booster Study to be treated with a single booster dose of sipuleucel-T.
Study Oversight
Has Oversight DMC:
True
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?:
None
Is an FDA AA801 Violation?: