high risk localized prostate cancer with homologous recombination repair abnormalities
Conditions
Interventions
Sponsors
Chinese PLA General Hospital
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years; 2. Histologically or cytologically confirmed prostate cancer, clinically identified as localized by imaging assessment and classified as high-risk or above according to the national comprehensive cancer network (NCCN) guidelines; 3. ECOG PS:0-1; 4. Life expectancy >= 10 years; 5. Radical prostatectomy as the main treatment for prostate cancer; 6. Homologous recombination repair defect by Homologous recombination deficiency (genomic instability) testing; 7. Normal bone marrow function: neutrophil count >= 1.5*10^9/L; platelet count >= 100*10^9/L; hemoglobin >= 90g/L; white blood cell count >= 3.6*10^9/L; 8. Normal liver function: alanine aminotransferase (ALT) or aspartate aminotransferase (AST) = 50%; QTc = 50 ml / min; 12. Understand and be willing to sign informed consent; 13. Be able to comply with the research visit schedule and other protocol requirements.
Exclusion criteria
Exclusion criteria: 1. With other malignant tumors. 2. Previous treatment includes PARP inhibitor therapy (e.g., olaparib, talazoparib, veliparib, niraparib, rucaparib or others), platinum based chemotherapy (such as cisplatin, carboplatin, oxaliplatin or others), mitoxantrone, cyclophosphamide, hormone deprivation therapy (luteinizing hormone releasing hormone [LHRH] agonist / antagonist), and antiandrogens (e.g., bicalutamide, enzalutamide, apalutamide) or new endocrine therapy (such as abirateron, enzalutamide and apalutamide). 3. Concomitant use of known strong CYP3A inhibitors (e.g. itraconazole, telithromycin, clarithromycin, protease inhibitors boosted with ritonavir or cobicistat, indinavir, saquinavir, nelfinavir, boceprevir, telaprevir) or moderate CYP3A inhibitors (e.g. ciprofloxacin, erythromycin, diltiazem, fluconazole, verapamil). The required washout period prior to starting fluzoparib is 2 weeks. 4. Concomitant use of known strong CYP3A inducers (e.g. phenobarbital, phenytoin, rifampicin, rifabutin, rifapentine, carbamazepine, nevirapine and St John's Wort) or moderate CYP3A inducers (e.g. bosentan, efavirenz, modafinil). The required washout period prior to starting fluzoparib is 5 weeks for phenobarbital or enzalutamide and 3 weeks for other agents. 5. HIV or AIDS or other immune deficiency related diseases, active or symptomatic viral hepatitis or chronic liver disease. 6. Clinically significant heart diseases, such as NYHA III-IV heart failure, myocardial infarction or arterial thrombosis in the past 6 months, severe or unstable angina pectoris or recent ventricular arrhythmia. 7. Preexisting duodenal stents and / or any gastrointestinal disease or defect considered by the investigator to interfere with drug absorption. 8. Hypersensitivity to fluzoparide or the active ingredients of ADT drugs used or any excipients. 9. Any reason unappropriate to participate in this clinical trial by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| pCR; | — |
Secondary
| Measure | Time frame |
|---|---|
| Margin positive rate;Changes in tumor staging;PSA response rate;PSA-PFS;Biochemical recurrence time;AE; | — |
Countries
China
Contacts
Public ContactXu Zhang
Chinese PLA General Hospital
Outcome results
None listed