Taxotere Prostate Cancer New Indication Registration Trial in China

Study Overview
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Brief Summary
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To compare overall survival after receiving mitoxantrone and prednisone or docetaxel and prednisone in subjects with hormone-refractory metastatic prostate cancer.

Official Title
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An Multicenter, Randomized Study of Comparison of Docetaxel Plus Prednisone With Mitoxantrone Plus Prednisone in the Patients With Hormone-refractory (Androgen-independent) Metastatic Prostate Cancer

Conditions
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Prostatic Neoplasms

Intervention / Treatment
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* Drug: Docetaxel
* Drug: Mitoxantrone
* Drug: Prednisone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically or cytologically proven prostate adenocarcinoma Androgen independent prostate Cancer S/P orchiectomy and/or LHRH agonist Testosterone < 50 ng/dl (ie 1.735 nmol/l) Documented progressive disease Patients should have achieved stable analgesia for 7 days Karnofsky Performance Status ≥ 70 No prior treatment with cytotoxic agent (except estramustine) Normal cardiac function must be confirmed by Left ventricular ejection fraction Adequate organ function: Hematology: Neutrophils > 1.5 x 10^9/L Hemoglobin > 10 g/dl. Erythropoietin use is allowed, but red blood cell transfusion to upgrade the hemoglobin level is not allowed Platelets > 100 x 10^9/L Hepatic function: Total bilirubin < the upper-normal limit of the institution. Alanine aminotransferase and Aspartate transaminase < 1.5 times the upper-normal limit of the institution. Renal function: Creatinine < 1.5 times the upper normal limit (ie National Cancer Institution grade < 1) No brain or leptomeningeal metastases Exclusion Criteria: Prior radiotherapy to >25% of bone marrow (whole pelvic irradiation is not allowed) prior cytotoxic chemotherapy, except monotherapy with estramustine prior isotope therapy history of another cancer within the preceding five year symptomatic peripheral neuropathy grade ≥ 2 other serious illness or medical condition: Congestive heart failure even if controlled. Previous history of myocardial infarction or angina pectoris within 1 year from study entry, uncontrolled hypertension or uncontrolled arrhythmias. Active uncontrolled infection Peptic ulcer, unstable diabetes mellitus or other contraindications for the use of corticosteroids. Auto-immune disease (lupus, sclerodermia, rheumatoid polyarthritis) treatment with any other anti-cancer therapy treatment with bisphosphonates The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Docetaxel 75mg/m² intravenously (day 1) every 21 days, plus prednisone 10mg orally given daily, minimal for 6 cycles and up to 10 cycle | Drug: Docetaxel<br>* 75mg/m² intravenously (day 1) every 21 days<br>Drug: Prednisone<br>* 10mg orally given daily<br>|
| Active Comparator: 2<br>Mitoxantrone 12mg/m² intravenously every 21 days, plus prednisone 10mg orally given daily, minimal for 6 cycles and up to 10 cycle | Drug: Mitoxantrone<br>* 12mg/m² intravenously every 21 days<br>Drug: Prednisone<br>* 10mg orally given daily<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: Overall survival |  | From beginning to end of the study | 
| Objective response rate of patients with measurable disease by Response Evaluation Criteria in Solid tumours |  | From beginning to end of study | 
| Prostatic Specific Antigen response |  | From the beginning to the end of study | 
| Pain response (McGill-Melzack Scale) |  | From beginning to end of study | 
| Time to progression |  | From beginning to end of study | 
| Adverse event |  | From beginning to end of study | 
| Quality Of Life: Functional assessment of chronic illness therapy-prostate questionnaire will be used |  | From beginning to end of study |