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A Study of Pamiparib Combined With Abiraterone Acetate in Neoadjuvant Treatment of Prostate Cancer

Neoadjuvant Therapy Clinical Trial

Official title:
A Prospective Clinical Study of the Safety and Efficacy of Pamiparib Combined With Abiraterone Acetate in Neoadjuvant Treatment of High-risk or Very High-risk Localized Prostate Cancer

Clinical Trial Summary

To evaluate the pathological response rate of pamiparib combined with abiraterone acetate in neoadjuvant therapy for surgically resectable high-risk or very high-risk prostate cancer after radical prostatectomy

Clinical Trial Description

the main purpose: To evaluate the pathological response rate of pamiparib combined with abiraterone acetate in neoadjuvant treatment of surgically resectable high-risk or very high-risk prostate cancer after radical prostatectomy; Note: pathological response rate = pathological complete response rate (pCR) + minimal residual disease (MRD)(defined as residual tumor with the largest crosssection dimension ≤5 mm OR RCB≤0.25CM³) Secondary purpose: 1. To evaluate the safety of pamiparib combined with abiraterone acetate as neoadjuvant therapy for high-risk or very high-risk prostate cancer; 2. To evaluate the rate of PSA biochemical recurrence-free survival (bPFS) at 1 year after radical prostatectomy in neoadjuvant treatment of high-risk or very-high-risk prostate cancer with pamiparib combined with abiraterone acetate; 3. The positive rate of surgical margins in radical prostatectomy; 4. Downstaging rate of radical prostatectomy; 5. Pathological response rate of neoadjuvant patients with HRR gene mutation; ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05376722
Study type Interventional
Source The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Contact hongqian guo, Dr.
Phone 13605171690
Email dr.ghq@163.com
Status Recruiting
Phase Phase 2
Start date February 22, 2022
Completion date September 2024
View Details
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