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: 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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
30
pamiparib 40 mg orally, twice a day
biraterone acetate 1000 mg orally, once a day
prednisone acetate tablets (prednisone) 5 mg, once a day
Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University
Nanjing, Jiangsu, China
RECRUITINGDepartment of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University
Nanjing, Jiangsu, China
RECRUITINGThe Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
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
Time frame: up to 6months
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.
Time frame: Baseline up to 30 days after the last dose of study drug or before initiation of a new antitumor treatment, whichever occurred first
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
Time frame: 3 years
Rate of Positive Surgical Margins
The proportion of subjects with positive surgical margins after radical prostatectomy
Time frame: up to 8 months
Downstaging rate of radical prostatectomy
Downstaging rate of radical prostatectomy
Time frame: four months to 2 years after surgery
Pathological response rate of neoadjuvant patients with HRR gene mutation
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Pathological response rate of neoadjuvant patients with HRR gene mutation
Time frame: 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
Time frame: up to 2 years