NCT05376722

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

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

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Hongqian Guo · Academic / Other
• Sex: Male
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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;

Conditions

• Neoadjuvant Therapy

Interventions

Type	Name	Description
DRUG	pamiparib	pamiparib 40 mg orally, twice a day
DRUG	abiraterone	biraterone acetate 1000 mg orally, once a day
DRUG	prednisone	prednisone acetate tablets (prednisone) 5 mg, once a day

Timeline

• Start date: 2022-02-22
• Primary completion: 2023-09-01
• Completion: 2024-09-01
• First posted: 2022-05-17
• Last updated: 2023-01-05

Locations

3 sites across 1 country: China