Docetaxel in Hormone Refractory Prostate Cancer (HRPC)[Weekly or 3weekly TAX + Prednisone in HRPC]

Study Overview
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Brief Summary
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Primary objectives: To determine the response rate, measurable and non measurable, to Taxotere® in the second line setting. Secondary objectives: To evaluate the overall safety and toxicity of Taxotere®/prednisone combination as second line therapy in HRPC To evaluate PSA response (PSA: Prostate Specific Antigen) To evaluate symptomatic response To evaluate Quality of life To evaluate patient safety of weekly versus q3 weekly regimens of Taxotere®.

Official Title
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Multicenter Phase II Study of Taxotere (Docetaxel) Administered Weekly or Every Three Weeks in Combination With Prednisone as Second Line Chemotherapy in Patients With Hormone Refractory Prostate Cancer (HRPC)

Conditions
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Prostatic Neoplasms

Intervention / Treatment
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* Drug: docetaxel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histologically/cytologically proven prostate adenocarcinoma Progression or non response with previous chemotherapy regimen (excluding Taxotere®) Received previous mitoxantrone/prednisone or one other chemotherapy regimen including emcyt +/- vinblastine Castration levels of testosterone (<50 ng/dL ) ECOG performance status 0-2 Laboratory requirements : Hematology: Neutrophils ≥ 1.5 x 10^9/L Hemoglobin > 10 g/dL (prior transfusion permitted). Platelets ≥ 100 x 10^9/L Hepatic function: Total bilirubin < the upper-normal limit of the institution. ALAT (SGPT) and ASAT (SGOT) ≤ 1.5 times the upper-normal limit of the institution. Renal function: Creatinine ≤1.5 times the upper normal limit (i.e., NCI grade ≤1) No severe or uncontrolled disease Exclusion Criteria Chemotherapy within the last 4 weeks Anti-androgen therapy within the last 4 weeks. Prior malignancy except the following: adequately treated non-melanomatous skin cancer and superficial bladder cancer from which the patient has been disease-free for >2 years. Concurrent treatment with other experimental drugs. Participation in another clinical trial with any investigational drug within 30 days prior to study screening. Treatment with any other anti-cancer therapy (except LHRH agonists) including any prescribed compounds and/or OTC products for the treatment of prostate cancer must be stopped prior to study entry. Other serious illness, psychiatric or medical condition that would not permit the patient to be managed according to the protocol including active uncontrolled infection and significant cardiac dysfunction.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: docetaxel|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain (pain progression evaluated with the Present Pain Intensity scale form McGill-Melzack questionnaire) |  | During the Study Conduct | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analgesics (assessed by Pain Medication Log) |  | During the study conduct | 
| PSA (PSA response and PSA progression |  | During the study conduct | 
| Tumor lesion assessment, |  | During the study conduct | 
| Overall survival |  | During the study conduct | 
| Progression-free survival |  | During the study conduct | 
| Treatment emergent adverse events recorded by the investigator where intensity was according to NCI-CTC criteria: Standard hematology, blood chemistry and clinical exams. |  | from the inform consent signed up to the end of the study |