Ignite Creation Date:
2024-10-25 @ 7:53 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06655259
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-13
Brief Title:
Combination of TURP and Standard Systemic Therapy for MPCa
Sponsor:
None
Organization:
None
Study Overview
Official Title:
An Open-Label Prospective Single-Arm Clinical Phase II Study on the Efficacy and Safety of TURP Combined with Standard Systemic Therapy in Patients with Metastatic Prostate Cancer
Status:
RECRUITING
Status Verified Date:
2024-10
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:
CTUSMEP01
Brief Summary:
This is a Phase II open-label prospective single-arm clinical study designed to evaluate the efficacy and safety of combining transurethral resection of the prostate TURP with standard systemic therapy in patients with metastatic prostate cancer mPCa All participants will undergo TURP to relieve urinary obstruction and reduce tumor burden followed by androgen deprivation therapy ADT and second-generation anti-androgen agents such as abiraterone or enzalutamide The primary outcome is radiographic progression-free survival rPFS with secondary outcomes including overall survival OS biochemical progression-free survival bPFS PSA response rates at 3 and 6 months and quality of life assessments The trial will enroll 200 newly diagnosed metastatic prostate cancer patients with regular follow-up for monitoring disease progression and treatment safety The study will be conducted at Fudan University Cancer Hospital
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