Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06575257
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-26
Brief Title:
Neoadjuvant Therapy of Darolutamide Plus ADT for High Risk Prostate Cancer
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Neoadjuvant ADT - Darolutamide Followed by Radical Prostatectomy for High-risk Prostate Cancer a Randomized Open Label Trial
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine if treatment with Darolutamide plus androgen deprivation therapy ADT before radical prostatectomy RP with pelvic lymph node dissection pLND in participants with high-risk localized or locally advanced prostate cancer results in an improvement in pathological complete response pCR rate and pathological tumor volume with minimal residual disease MRD as compared to ADT
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None