Ignite Creation Date:
2024-06-16 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06435702
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-30
First Post:
2024-05-26
Brief Title:
Efficacy and Safety of Darolutamide in Combination With Androgen-Deprivation Therapy in Prostate Cancer Patients With Lymph Node-positive After Radical Prostatectomy A Prospective Observational Cohort Study
Sponsor:
Peking University Third Hospital
Organization:
Peking University Third Hospital
Study Overview
Official Title:
A Prospective Observational Cohort Study of Efficacy and Safety of Darolutamide in Combination With Androgen-Deprivation Therapy in Prostate Cancer Patients With Lymph Node-positive After Radical Prostatectomy
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
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 an open prospective single-center observational clinical study to evaluate the efficacy and safety of immediate adjuvant ADT with darotarolimide in the treatment of patients with positive lymph nodes after radical prostatectomy for prostate cancer
Detailed Description:
This study is an open prospective single-center observational clinical study to evaluate the efficacy and safety of immediate adjuvant ADT with darotarolimide in the treatment of patients with positive lymph nodes after radical prostatectomy for prostate cancer The study evaluates the efficacy of immediate adjuvant ADT with darotarolimide in patients with positive lymph nodes after radical prostatectomy for prostate cancer using time to achieve CRPC as the primary study endpoint OS will be examined in all patients after the primary study endpoint is achieved and will serve as the key secondary study endpoint It is planned to enroll 108 patients with positive lymph nodes after radical prostatectomy for prostate cancer It is divided into a screening period a treatment period and a follow-up period Patients will enter the screening period from the time they sign the informed consent form and those who have been evaluated and qualified in the screening period will be entered into the study Patients eligible for enrollment will receive 2 years of ADT treatment or ADT treatment darotarotide adjuvant therapy with or without combination radiotherapy at the investigators discretion
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?:
None
Is an FDA AA801 Violation?:
None