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

NCT05376722 | Unknown Phase 2

• 1 other identifier: IUNU-PC-111
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 3

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

Conditions

Neoadjuvant Therapy

Keywords

pamiparib; abiraterone acetate; high-risk prostate cancer

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (6)

• 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 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

• Rate of Positive Surgical Margins

  up to 8 months

• Downstaging rate of radical prostatectomy

  four months to 2 years after surgery

• Pathological response rate of neoadjuvant patients with HRR gene mutation

  four months to 2 years after surgery

Study Arms (1)

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

Drug: pamiparib; Drug: abiraterone; Drug: prednisone

Interventions

pamiparib DRUG

pamiparib 40 mg orally, twice a day

pamiparib

abiraterone DRUG

biraterone acetate 1000 mg orally, once a day

pamiparib

prednisone DRUG

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

pamiparib

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Multiparametric MRI and PSMA PET/CT scan or CT scan showing primary tumor stage ≥ T3;
• Primary tumor Gleason score ≥ 8;
• Serum PSA concentration ≥ 20 ng/ml;
• Imaging assessment has regional lymph node metastasis (N1);
• 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

You may not qualify if:

• Patients with neuroendocrine, small cell, or sarcomatoid features on prostate histopathology.
• Low- and intermediate-risk localized prostate cancer (all the following conditions are met) (PSA\<20 ng/mL; Gleason score\<8; clinical stage\<T3).
• Patients with clinical or radiological evidence suggestive of extraregional lymph node metastasis or bone or visceral metastasis (any M1).
• 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.
• Patients with severe or uncontrolled concurrent infections.
• 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.
• Uncontrolled severe hypertension, persistent uncontrolled diabetes, oxygen-dependent lung disease, chronic liver disease, or HIV infection.
• In the past 5 years, other malignancies other than prostate cancer, but cured basal or squamous cell skin cancer can be enrolled.
• Suffering from mental illness, mental disability or inability to give informed consent.

Sponsors & Collaborators

• Hongqian Guo: lead
• First Affiliated Hospital of Zhejiang University: collaborator
• The First Affiliated Hospital of Soochow University: collaborator
• Nanjing First Hospital, Nanjing Medical University: collaborator

Study Sites (3)

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

Nanjing, Jiangsu, 210000, China

RECRUITING

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

Nanjing, Jiangsu, 210000, China

RECRUITING

The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Nanjing, Jiangsu, 210000, China

RECRUITING

MeSH Terms

Interventions

pamiparib; abiraterone; Prednisone

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• shun zhang, Dr.

  The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

  PRINCIPAL INVESTIGATOR

Central Study Contacts

hongqian guo, Dr.

CONTACT

13605171690; dr.ghq@163.com

shun zhang, Dr.

CONTACT

15050589789; explorershun@126.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief physician

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: May 17, 2022
• Study Start: February 22, 2022
• Primary Completion: September 1, 2023
• Study Completion: September 1, 2024
• Last Updated: January 5, 2023

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)