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| Name | Class |
|---|---|
| First Affiliated Hospital of Zhejiang University | OTHER |
| The First Affiliated Hospital of Soochow University | OTHER |
| Nanjing First Hospital, Nanjing Medical University | OTHER |
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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
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| pamiparib | Experimental | Subjects received pamiparib 40 mg orally, twice a day; abiraterone acetate 1000 mg orally, once a day; prednisone acetate tablets (prednisone) 5 mg, once a day; every 30 days Treatment cycle, treatment for 4-6 cycles, that is, 4-6 months. Robot-assisted laparoscopic radical prostatectomy and extended lymph node dissection within 30 days of the end of 4 months of neoadjuvant therapy. If the subjects have intolerable toxic reactions during the treatment period, the dose adjustment can be carried out. Day 1 of cycle 1, day 15 and day 1±3 days of each cycle thereafter, and 1 follow-up within 30 days after the end of treatment and before surgery; 1 prostate MRI during the screening period and within 30 days after the end of treatment and before surgery Scan, PSMA PET/CT scan or CT scan |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| pamiparib | Drug | pamiparib 40 mg orally, twice a day |
| |
| abiraterone |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 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 | up to 6months |
| Measure | Description | Time Frame |
|---|---|---|
| AEs/SAEs | The level of AEs defined by NCI-CTCAE v5.0. Safety assessments will be assessed and documented after initiation of study drug, regardless of relationship to study drug. The level of complications defined by Clavien-Dindo classification. | Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first |
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Inclusion Criteria:
Inclusion Criteria:
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:
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 Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| hongqian guo, Dr. | Contact | 13605171690 | dr.ghq@163.com | |
| shun zhang, Dr. | Contact | 15050589789 | explorershun@126.com |
| Name | Affiliation | Role |
|---|---|---|
| shun zhang, Dr. | The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University | Recruiting | Nanjing | Jiangsu | 210000 | China |
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| ID | Term |
|---|---|
| C000707927 | pamiparib |
| C089740 | abiraterone |
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Drug |
biraterone acetate 1000 mg orally, once a day |
|
| prednisone | Drug | prednisone acetate tablets (prednisone) 5 mg, once a day |
|
| the 1-year PSA biochemical recurrence-free survival (bPFS) rate after radical prostatectomy in neoadjuvant therapy of paamiparib combined with abiraterone acetate in high- or very-high-risk prostate cancer | Defined as the proportion of patients who did not experience biochemical progression or death within 3 years of initiation of pamiparib treatment; biochemical progression was defined as an increase in serum PSA level to >0.2 ng/ml with 2 consecutive increases at least 3 months apart | 3 years |
| Rate of Positive Surgical Margins | The proportion of subjects with positive surgical margins after radical prostatectomy | up to 8 months |
| Downstaging rate of radical prostatectomy | Downstaging rate of radical prostatectomy | four months to 2 years after surgery |
| Pathological response rate of neoadjuvant patients with HRR gene mutation | Pathological response rate of neoadjuvant patients with HRR gene mutation | four months to 2 years after surgery |
| PSA response rate | The proportion of subjects with a ≥98% reduction in nadir PSA from baseline PSA during neoadjuvant therapy | up to 2 years |
| Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University | Recruiting | Nanjing | Jiangsu | 210000 | China |
|
| The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School | Recruiting | Nanjing | Jiangsu | 210000 | China |
|
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |