Status:
UNKNOWN
Docetaxel Versus Abiraterone as First-line Treatment in mCRPC Patients With Intraductal Carcinoma of the Prostate
Lead Sponsor:
West China Hospital
Conditions:
Prostate Cancer
Castration-resistant Prostate Cancer
Eligibility:
MALE
40+ years
Phase:
PHASE2
Brief Summary
Metastatic castration-resistant Prostate cancer (mCRPC) is a very late stage of prostate cancer with poor prognosis. Although there are several treatment strategies available for mCRPC, these drugs ar...
Eligibility Criteria
Inclusion
- Age: ≥40 years old
- Positive IDC-P status confirmed by pathological examination.
- Bone or visceral metastatic disease confirmed by image examination.
- Castration resistant confirmed according to the criteria of 2014 EAU guidelines.
- The ECOG score of the patient is ≤1
- Expected survival over 3 months
- Blood routine test: neutrophil ≥1.5 × 10\^9, platelets \>100 × 10\^9 and hemoglobin ≥90g/L
- Blood biochemical indexes: bilirubin≤1.5×Upper limit of normal; AST≤2.5×Upper limit of normal; serum creatinine≤1.5×Upper limit of normal; serum calcium≤12.0mg/dL.
- Coagulation function: Prothrombin time ≤1.5×Upper limit of normal
- The following diseases were not found within 12 months: myocardial infarction, severe or unstable angina pectoris, asymptomatic heart failure, cardiovascular and cerebrovascular accident or transient ischemic attack, etc.
- All patients should sign informed consent.
Exclusion
- Patients who had other types of cancer besides prostate cancer were excluded.
- Patients With non-acinar adenocarcinoma except intraductal carcinoma of the prostate, including ductal adenocarcinoma, neuroendocrine carcinoma or small cell carcinoma of the prostate.
- Prior chemotherapy or abiraterone for the treatment of mCRPC.
- Patients with renal decompensation requiring hemodialysis or peritoneal dialysis.
- Patients with severe active clinical infection
- Patients with coagulopathy or bleeding
- Patients who received major surgery or severe trauma within the first 4 weeks before admission.
- Patients with a history of allogeneic organ transplantation or bone marrow transplantation
- Patients with known or suspected allergy to research drugs.
Key Trial Info
Start Date :
November 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2020
Estimated Enrollment :
140 Patients enrolled
Trial Details
Trial ID
NCT03356444
Start Date
November 1 2017
End Date
December 1 2020
Last Update
November 29 2017
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