Neoadjuvant Therapy
Conditions
Keywords
pamiparib, abiraterone acetate, high-risk prostate cancer
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 prostatectomy
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 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;
Interventions
DRUGpamiparib
pamiparib 40 mg orally, twice a day
DRUGabiraterone
biraterone acetate 1000 mg orally, once a day
DRUGprednisone
prednisone acetate tablets (prednisone) 5 mg, once a day
Sponsors
First Affiliated Hospital of Zhejiang University
The First Affiliated Hospital of Soochow University
Nanjing First Hospital, Nanjing Medical University
Hongqian Guo
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Inclusion Criteria: 1. Men aged ≥18 years and ≤80 years old. 2. Patients with prostate cancer diagnosed by histology or cytology who are suitable for radical prostatectomy. 3. All patients meet at least one of the following criteria: 1. Multiparametric MRI and PSMA PET/CT scan or CT scan showing primary tumor stage ≥ T3; 2. Primary tumor Gleason score ≥ 8; 3. Serum PSA concentration ≥ 20 ng/ml; 4. Imaging assessment has regional lymph node metastasis (N1); 4. Eastern Cooperative Oncology Group (ECOG) performance status score≤1 5. 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. 6. 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. 7. During the treatment, the testosterone level in the blood is reduced to the castration level, and the testosterone level is less than 50ng/dL; 8. The subjects can understand and are willing to sign the informed consent
Exclusion criteria
*
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 3 years | 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 |
| Rate of Positive Surgical Margins | up to 8 months | The proportion of subjects with positive surgical margins after radical prostatectomy |
| AEs/SAEs | Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first | 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. |
| Pathological response rate of neoadjuvant patients with HRR gene mutation | four months to 2 years after surgery | Pathological response rate of neoadjuvant patients with HRR gene mutation |
| PSA response rate | up to 2 years | The proportion of subjects with a ≥98% reduction in nadir PSA from baseline PSA during neoadjuvant therapy |
| Downstaging rate of radical prostatectomy | four months to 2 years after surgery | Downstaging rate of radical prostatectomy |
Countries
China
Contacts
Primary Contacthongqian guo, Dr.
Backup Contactshun zhang, Dr.
Outcome results
None listed