Docetaxel Versus Abiraterone as First-line Treatment in mCRPC Patients With Intraductal Carcinoma of the Prostate
NCT ID: NCT03356444
Last Updated: 2017-11-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
140 participants
INTERVENTIONAL
2017-11-30
2020-12-31
Brief Summary
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In the previous works of the investigators, a subtype of prostate cancer, intraductal carcinoma of the prostate (IDC-P) was studied. The investigators have reported in their two published papers that, IDC-P is an adverse pathological type associated with rapid disease progression. They also found in another study that, for patients with IDC-P, Abiraterone seemed to have better treatment efficacy than Docetaxel-based chemotherapy as first-line treatment for mCRPC, in terms of either PSA-response and PSA-progression free survival. So, in this study, the investigators hope to design a prospective study to verify the predictive ability of IDC-P in the first-line treatment of mCRPC.
With disease progression, the drug resistance will inevitably occur in all patients after the treatment of CRPC. However, the exact mechanism of this process is not yet known. So, in this study the investigators are also trying to explore some of the genes related to the treatment efficacy by means of the next generation sequencing.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Abiraterone group
Abiraterone acetate is administered in this arm.
Abiraterone Acetate
Abiraterone Acetate: orally, 1000mg, qd, plus with prednisone orally, 5mg, bid. Course of treatment: Stop the treatment until biochemical, clinical or radiographic progression occurs.
Docetaxel group
Docetaxel is administered in this arm.
Docetaxel
Docetaxel: intravenously, 75 mg/m\^2, over 1 h every 3 weeks, plus with prednisone, orally, 10 mg, qd.
Course of treatment: Stop the treatment until biochemical, clinical or radiographic progression occurs. If no progression, stop until 10 cycles of traetment
Interventions
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Abiraterone Acetate
Abiraterone Acetate: orally, 1000mg, qd, plus with prednisone orally, 5mg, bid. Course of treatment: Stop the treatment until biochemical, clinical or radiographic progression occurs.
Docetaxel
Docetaxel: intravenously, 75 mg/m\^2, over 1 h every 3 weeks, plus with prednisone, orally, 10 mg, qd.
Course of treatment: Stop the treatment until biochemical, clinical or radiographic progression occurs. If no progression, stop until 10 cycles of traetment
Eligibility Criteria
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Inclusion Criteria
2. Positive IDC-P status confirmed by pathological examination.
3. Bone or visceral metastatic disease confirmed by image examination.
4. Castration resistant confirmed according to the criteria of 2014 EAU guidelines.
5. The ECOG score of the patient is ≤1
6. Expected survival over 3 months
7. Blood routine test: neutrophil ≥1.5 × 10\^9, platelets \>100 × 10\^9 and hemoglobin ≥90g/L
8. 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.
9. Coagulation function: Prothrombin time ≤1.5×Upper limit of normal
10. 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.
11. All patients should sign informed consent.
Exclusion Criteria
2. Patients With non-acinar adenocarcinoma except intraductal carcinoma of the prostate, including ductal adenocarcinoma, neuroendocrine carcinoma or small cell carcinoma of the prostate.
3. Prior chemotherapy or abiraterone for the treatment of mCRPC.
4. Patients with renal decompensation requiring hemodialysis or peritoneal dialysis.
5. Patients with severe active clinical infection
6. Patients with coagulopathy or bleeding
7. Patients who received major surgery or severe trauma within the first 4 weeks before admission.
8. Patients with a history of allogeneic organ transplantation or bone marrow transplantation
9. Patients with known or suspected allergy to research drugs.
40 Years
MALE
No
Sponsors
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West China Hospital
OTHER
Responsible Party
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Hao Zeng
Professor
Other Identifiers
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2017-16
Identifier Type: -
Identifier Source: org_study_id