To investigate the clinical effect and ctDNA dynamic change of 'Jianpi-Lishi-Huayu Decoction' on the 'maximum androgen blocking' of advanced prostate cancer
- Conditions
- Prostate cancer
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Male
- Target Recruitment
- Not specified
1) Male, in line with the Western medical diagnostic criteria of Diagnostic Criterion for Prostate Cancer, confirmed as prostate cancer by biopsy and puncture, and not complicated with neuroendocrinization, signet ring cell or small cell characteristics;
2) It meets the American Joint Committee on Cancer (AJCC) 8th edition TNM staging criteria for prostate cancer, which are T3-4, N0-1, M0-1;
3) Diagnostic criteria of traditional Chinese medicine: with reference to the teaching material of TCM oncology (dai-han zhou editor, guangzhou higher education press, 2007) and the standard of China association of Chinese medicine tumor diagnosis and treatment of traditional Chinese medicine guide (2008) and the malignant tumor diagnosis and treatment of traditional Chinese medicine guide (hong-sheng Lin editor, people's medical publishing house, 2014), the state bureau of technical supervision issued term in the clinical diagnosis and treatment of TCM syndrome part (1997).
4) No previous endocrine therapy related to prostate cancer;
5) According to Zubrod-Ecog-WHO (ZPS, 5-point method) scoring criteria, the baseline assessment of patients before enrolment should meet 0-2 points;
6) Bone marrow hematopoietic function was not significantly impaired (WBC >= 3.5 x 10^9/L, platelet >= 100 x 10^9/L, hemoglobin >= 90g/L);
7) Biochemical examination shall meet the following standards:
a. TBIL < 1.5 x ULN;
b. ALT and AST < 2 ULN (<= 5 x ULN if abnormal liver function is caused by liver metastasis);
c. serum Cr acuities were 1.25 x ULN or endogenous creatinine clearance > 45 ml/min (Cockcroft - Gault formula);
d. Coagulation function should meet the following criteria: INR <= 1.5 and APTT <= 1.5 x ULN;
8) The expected survival time is not less than 12 weeks;
9) Patients volunteered to participate in this study with good compliance, can cooperate with treatment and observation, and sign informed consent form (ICF).
1) Patients with serious primary diseases of the heart, brain, liver and hematopoietic system or with other cancers;
2) Patients with renal injury due to spinal cord compression or urinary tract obstruction, or who are at risk of developing this phenomenon;
3) Allergic to carlutamine or any component of the preparation;Have a history of allergy to goserrelin acetate/leproterreli;
4) People with central nervous system disorders or mental disorders, with a clear history of previous neurological or mental disorders, including epilepsy or dementia;
5) There are many factors that affect the absorption of oral drugs (such as inability to swallow, nausea and vomiting, chronic diarrhea and intestinal obstruction);
6) Participated in other clinical trials within the last 3 months;n acetate preparation ingredients, synthetic LH-RH or LH-RH derivatives;
7) The Investigator believes that there is any condition that may harm the subject or cause the subject to fail to meet or perform the study requirements;
8) Increases the risk of participating in the study or of the study drug and, in the investigator's judgment, may result in a serious disease or non-tumor comorbidity that would ineligible the patient for inclusion in the study;
9) Patients failed to comply with the protocol;
10) Other patients deemed unsuitable for inclusion by attending physicians.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method tPSA, fPSA;Liver and kidney function;EORTC QLQ-C30;TCM clinical symptom scoring;ISS;IPSS;KPS;coagulation function;testosterone;blood routine examination;
- Secondary Outcome Measures
Name Time Method ECT;Prostate CT/MRI;