prostate cancer
Conditions
Interventions
Experimental group:fluzoparib plus nab-paclitaxel
Sponsors
Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. The subjects voluntarily join this study, sign the informed consent form, have good compliance, and cooperate with the follow-up; 2. Age 18-75 years old (including boundary age); 3. Pathologically confirmed metastatic castration-resistant prostate cancer; able to cooperate with blood sample collection, tumor tissue biopsy and/or provide sufficient archived tissue samples for biomarker testing; 4. After surgery or drug castration, testosterone level 20ng/ml, or Gleason score = 8; 6. ECOG score: 0-1; 7. Expected survival = 12 weeks; 8. The function of important organs meets the following requirements (no blood components and cell growth factors are allowed within 14 days before the first administration): absolute neutrophil count =1.5×10^9/L; platelet =100×10^9/L; hemoglobin =10g/dL; serum albumin =3g/dL; bilirubin =1.5 times ULN; ALT and AST =3 times ULN; serum creatinine =1.5 times ULN; 9. If the subjects and their partners have potential fertility, they need to use a medically approved contraceptive method (such as intrauterine device, contraceptive pill or condom) during the study treatment and within 3 months after the end of the study treatment.
Exclusion criteria
Exclusion criteria: Exclusion criteria 1. Previously received any PARP inhibitor treatment; 2. Participated in another drug clinical trial or planned to participate in another interventional clinical trial within 30 days before enrollment; 3. Resting electrocardiogram shows uncontrolled or potential cardiac diseases (including but not limited to: unstable ischemia, uncontrolled symptomatic arrhythmia, congestive heart failure, QT interval prolonged >500 ms after Fridericia correction, congenital long QT syndrome); 4. Received any systemic anti-cancer treatment (except radiotherapy) within 3 weeks before the study treatment; 5. Combined use of known potent CYP3A inhibitors (such as itraconazole, troleandomycin, clarithromycin, ritonavir or cobicistat-enhanced protease inhibitors, indinavir, saquinavir, nelfinavir, bupropion, telithromycin) or moderate CYP3A inhibitors (such as ciprofloxacin, erythromycin, thioridazine, fluconazole, verapamil), requiring a washout period of 2 weeks before fluzoparib treatment; 6. Previous cancer treatment caused long-term toxicity (CTCAE > grade 2), excluding hair loss or toxicity caused by LHRH agonists or antagonists; 7. Subjects with myelodysplastic syndrome/acute myeloid leukemia or characteristics suggestive of MDS/AML; 8. Subjects who cannot swallow oral drugs and/or have gastrointestinal diseases that may interfere with the absorption of study drugs; 9. Subjects who are allergic to fluzoparib or any excipients of this product; 10. Immunocompromised subjects, such as subjects with positive serological test results for human immunodeficiency virus (HIV); 11. Subjects with known active hepatitis (such as hepatitis B or C); 12. Subjects with severe, uncontrolled internal diseases or non-malignant systemic diseases, or uncontrolled active infections.(Including but not limited to: uncontrolled ventricular arrhythmia, myocardial infarction within 12 weeks, uncontrolled seizures, extensive interstitial lung disease in both lungs or mental illness that hinders signing the informed consent form.)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Progression Free Survival; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective Response Rate;Overall Survival ;Adverse Reactions, AR; | — |
Countries
China
Contacts
Public ContactZhu Dongyuan
Shandong Cancer Hospital and Institute, Shandong First Medical University and Shandong Academy of Medical Sciences
Outcome results
None listed