Prostate cancer
Conditions
Interventions
Experimental:Fluzoparib +abiraterone
Sponsors
Qilu Hospital of Shandong University
Eligibility
Sex/Gender
Male
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18-75 years old; 2. The subject's ability to understand and be willing to sign an informed consent form; 3. Able to comply with the research visit schedule and other agreement requirements; 4. The patient must have prostate cancer confirmed by histology or cytology, which has been clinically determined as localized according to imaging evaluation, and classified into high-risk or above according to the National Comprehensive Cancer Network (NCCN) guidelines (high-risk group is no extremely high-risk group Features and at least one of the following high-risk features: (1) Tumor staging is T3a; (2) Grading into 4 or 5 groups; (3) PSA >20 ng/mL; Very high-risk group has at least one of the following: (1) Tumor staging is T3b-T4; (2) The main Gleason classification is 5; (3) There are 2 or 3 high-risk features; (4) >4 needle grading into 4 or 5 groups), patients with oligometastasis prostate cancer must have no visceral metastasis, and there must be = 10 years; 7. Men who choose prostate cancer surgery as the main treatment for prostate cancer; 8. Willing to accept preoperative and postoperative genetic testing; 9. Normal liver function: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) = 50 mL/min.
Exclusion criteria
Exclusion criteria: 1. With activated second malignant tumor; 2. Patients whose prostate histopathology has neuroendocrine, small cell or sarcoma-like characteristics; 3. Past treatments including PARP inhibitors (such as olaparib, talazoparib, veliparib, niraparib, rucaparib or others), platinum chemotherapy (such as cisplatin, carboplatin, oxaliplatin or others) and mitoxantrone, cyclophosphamide , Hormone deprivation therapy (Luteinizing hormone releasing hormone [LHRH] agonist/antagonist), antiandrogens (such as bicalutamide, nilutamide, enzalutamide, apalutamide) or new endocrine therapy ( For example, Abiraterone, Enzalutamide, Apalutamide, etc.) for treatment; 4. Known human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS) related diseases, active or symptomatic viral hepatitis or chronic liver disease; 5. Clinically significant heart disease, such as myocardial infarction or arterial thrombosis in the past 6 months, severe or unstable angina; 6. Pre-existing duodenal stent and/or any gastrointestinal disease or defect that the researcher thinks will interfere with drug absorption; 7. The investigator believes that it is not suitable to participate in this clinical trial for any reason.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pathological complete response, pCR;Minimal resideal disease, MRD; | — |
Secondary
| Measure | Time frame |
|---|---|
| Margin positive rate;Tumor staging change;PSA response rate;PSA progression-free survival (PSA-PFS); | — |
Countries
China
Contacts
Public ContactShi Benkang
Qilu Hospital of Shandong University
Outcome results
None listed