Prostate cancer
Conditions
Interventions
Case series :none
Sponsors
Shanghai Jiaotong University School of Medicine Ruijin-Hainan Hospital(Hainan Boao Research Hopspital)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) Age= 18 years male 2) Histologically or cytologically confirmed adenocarcinoma of the prostate without small cell or signet cell futures 3) Metastatic lesions confirmed by bone scan, CT, MRI, PSMA-PET/CT 4) mCRPC disease state without any treatment, except for ADT 5) HRR mutation confirmed by tumor tissue or blood (germline or somatic mutation) 6) Evidence of informed consent signed and dated by the subject or legal representative, indicating that the subject (or legal representative) is aware of all relevant aspects of the study 7) Subjects who will accept Talazoparib plus Enzalutamide therapy, or subjects who have already taken Talazoparib plus Enzalutamide within the past 6 months (26 weeks) and will continue Talazoparib plus Enzalutamide therapy, and are willing to follow up visits within current clinical practice.
Exclusion criteria
Exclusion criteria: 1)Significant renal dysfunction as defined by eGFR 1·5 times the upper limit of normal (ULN) (>3 × ULN for patients with documented Gilbert syndrome or for whom indirect bilirubin concentrations suggest an extrahepatic source of elevation). ? Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2·5 times ULN (>5 × ULN if liver function abnormalities are due to hepatic metastasis). ? Albumin <2·8 g/dL. 3)Absolute neutrophil count (ANC) <1500/µL, platelets <100,000/µL, or hemoglobin <9 g/dL (may not have received growth factors or blood transfusions within 14 days before obtaining the hematology laboratory tests at screening).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PSA50 at6month; | — |
Secondary
| Measure | Time frame |
|---|---|
| objective response rate;safety; | — |
Countries
CHINA
Contacts
Public ContactDanfeng Xu
Shanghai Jiaotong University School of Medicine Ruijin-Hainan Hospital(Hainan Boao Research Hopspital)
Outcome results
None listed