Status:
UNKNOWN
A Study of Pamiparib Combined With Abiraterone Acetate in Neoadjuvant Treatment of Prostate Cancer
Lead Sponsor:
Hongqian Guo
Collaborating Sponsors:
First Affiliated Hospital of Zhejiang University
The First Affiliated Hospital of Soochow University
Conditions:
Neoadjuvant Therapy
Eligibility:
MALE
18-80 years
Phase:
PHASE2
Brief 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 pro...
Detailed 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 cance...
Eligibility Criteria
Inclusion
- Men aged ≥18 years and ≤80 years old.
- Patients with prostate cancer diagnosed by histology or cytology who are suitable for radical prostatectomy.
- All patients meet at least one of the following criteria:
- Multiparametric MRI and PSMA PET/CT scan or CT scan showing primary tumor stage ≥ T3;
- Primary tumor Gleason score ≥ 8;
- Serum PSA concentration ≥ 20 ng/ml;
- Imaging assessment has regional lymph node metastasis (N1);
- Eastern Cooperative Oncology Group (ECOG) performance status score≤1
- Laboratory inspections meet the following requirements:
- Blood routine: white blood cell count (WBC) ≥3.0×109/L, platelet count ≥100×109/L, hemoglobin ≥9g/dl; renal function: serum creatinine ≤2×ULN; liver function: alanine aminotransferase (ALT) and Aspartate aminotransferase (AST)≤2.5×ULN, total bilirubin TBIL≤1.5×ULN; coagulation function: international normalized ratio (INR)\<1.5.
- The subjects participate voluntarily, and the subjects themselves must sign the Informed Consent Form (ICF), indicating that they understand the purpose and required procedures of this research, and are willing to participate in the research. Subjects must be willing and comply with the prohibitions and restrictions set forth in the study protocol.
- During the treatment, the testosterone level in the blood is reduced to the "castration" level, and the testosterone level is less than 50ng/dL;
- The subjects can understand and are willing to sign the informed consent
Exclusion
Key Trial Info
Start Date :
February 22 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2024
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05376722
Start Date
February 22 2022
End Date
September 1 2024
Last Update
January 5 2023
Active Locations (3)
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1
Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University
Nanjing, Jiangsu, China, 210000
2
Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University
Nanjing, Jiangsu, China, 210000
3
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China, 210000