Ignite Creation Date:
2024-05-06 @ 5:14 PM
Last Modification Date:
2024-10-26 @ 2:25 PM
Study NCT ID:
NCT05249712
Status:
RECRUITING
Last Update Posted:
2023-01-03
First Post:
2022-02-10
Brief Title:
Efficacy and Safety of Darolutamide Combined With ADT in High-riskVery High-risk Localized Prostate Cancer
Sponsor:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Organization:
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Study Overview
Official Title:
Medical Ethics Committee of Nanjing Drum Tower Hospital Affiliated to Medical School of Nanjing University
Status:
RECRUITING
Status Verified Date:
2022-12
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 trial aims to evaluate the efficacy and safety of neoadjuvant therapy with Darolutamide combined with Androgen-Deprivation Therapy in High-riskVery high-risk localized prostate cancer This trial is A prospective single-arm multicenter clinical trial Treatment cycle is 24 weeks
Detailed Description:
High risk prostate cancer PCa had worse outcomes on radical treatment results short-time oncological results even cancer-specific survival than those low or mediate risk PCa Neoadjuvant treatment before radical prostatectomy had been proven to get some benefits on peri-operation results especially on reduction of tumor volume and minimization of biochemical recurrence This study will evaluate the efficacy and safety of androgen deprivation therapy ADT with Darolutamide in neoadjuvant therapy for surgically resectable high-risk or very high-risk PCa
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None