Prostate cancer
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Age = 18 years; Patients who have previously failed at least one chemotherapy regimen containing docetaxel and one standard novel endocrine therapy; Meeting the diagnostic criteria for CRPC, defined as: Sustained androgen deprivation therapy (ADT) with testosterone at castration levels < 50 ng/ml; Disease progression within 12 weeks prior to enrollment: Three consecutive PSA elevations at intervals of 1 week, with serum PSA = 2 ng/ml; Soft tissue progression assessed by RECIST criteria, or the appearance of = 2 new lesions on bone scan; Radiographic evidence of bone metastatic disease and/or measurable non-bone metastatic disease (lymph nodes or visceral organs); Expected survival = 3 months; No contraindications to traditional Chinese medicine treatment; All patients voluntarily sign an informed consent form and are able to adhere to treatment and follow-up.
Exclusion criteria
Exclusion criteria: 1) Severe cardiovascular or cerebrovascular diseases; 2) Abnormal liver function: Total serum bilirubin < 1.5 × upper limit of normal (ULN); blood ALT/AST < 2 × ULN; 3) Abnormal renal function: Serum creatinine = 1.5 mg/dL or creatinine clearance rate = 60 cc/min; 4) Allergy to the drugs used; 5) Patients with concurrent tumors in other sites.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Prostate-Specific Antigen; | — |
Secondary
| Measure | Time frame |
|---|---|
| Karnofsky Performance Status;Computed Tomography; | — |
Countries
China
Contacts
Zhongda Hospital Southeast University