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

NCT ID: NCT05376722

Last Updated: 2023-01-05

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-22
• Study Completion Date: 2024-09-30

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;

Conditions

Neoadjuvant Therapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

pamiparib

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

Group Type: EXPERIMENTAL

pamiparib

Intervention Type: DRUG

pamiparib 40 mg orally, twice a day

abiraterone

Intervention Type: DRUG

biraterone acetate 1000 mg orally, once a day

prednisone

Intervention Type: DRUG

prednisone acetate tablets (prednisone) 5 mg, once a day

Interventions

pamiparib

pamiparib 40 mg orally, twice a day

Intervention Type: DRUG

abiraterone

biraterone acetate 1000 mg orally, once a day

Intervention Type: DRUG

prednisone

prednisone acetate tablets (prednisone) 5 mg, once a day

Intervention Type: DRUG

Eligibility 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

1. Patients with neuroendocrine, small cell, or sarcomatoid features on prostate histopathology.

2. Low- and intermediate-risk localized prostate cancer (all the following conditions are met) (PSA<20 ng/mL; Gleason score<8; clinical stage<T3).

3. Patients with clinical or radiological evidence suggestive of extraregional lymph node metastasis or bone or visceral metastasis (any M1).

4. Received androgen deprivation therapy (including drug or surgical castration) for more than 3 months or focal prostate cancer treatment or prostate cancer radiotherapy and chemotherapy in the past.

5. Patients with severe or uncontrolled concurrent infections.

6. Suffering from New York Heart Association (NYHA) class III/IV congestive heart failure, unstable angina or a history of myocardial infarction within the past 6 months.

7. Uncontrolled severe hypertension, persistent uncontrolled diabetes, oxygen-dependent lung disease, chronic liver disease, or HIV infection.

8. In the past 5 years, other malignancies other than prostate cancer, but cured basal or squamous cell skin cancer can be enrolled.

9. Suffering from mental illness, mental disability or inability to give informed consent.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

First Affiliated Hospital of Zhejiang University

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Soochow University

OTHER

Sponsor Role: collaborator

Nanjing First Hospital, Nanjing Medical University

OTHER

Sponsor Role: collaborator

Hongqian Guo

OTHER

Sponsor Role: lead

Responsible Party

Hongqian Guo

Chief physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

shun zhang, Dr.

Role: PRINCIPAL_INVESTIGATOR

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Locations

Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University

Nanjing, Jiangsu, China

Site Status: RECRUITING

Department of Urology, Drum Tower Hospital, Medical School of Nanjing University, Institute of Urology, Nanjing University

Nanjing, Jiangsu, China

Site Status: RECRUITING

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

Site Status: RECRUITING

Countries

China

Central Contacts

hongqian guo, Dr.

Role: CONTACT

dr.ghq@163.com

13605171690

shun zhang, Dr.

Role: CONTACT

explorershun@126.com

15050589789

Facility Contacts

Shun Zhang

Role: primary

explorershun@126.com

15050589789 ext. 15050589789

Junlong Zhuang, MD

Role: primary

zhuangjl-2008@163.com

8615950451917

Hongqian Guo, Phd

Role: primary

dr.ghq@nju.edu.cn

8613605171690

Shun Zhang, MD

Role: backup

explorershun@126.com

8615050589789

Other Identifiers

IUNU-PC-111

Identifier Type: -

Identifier Source: org_study_id