Combination of Docetaxel + Estramustine + Hydrocortisone Versus Docetaxel + Prednisone in Patients With Advanced Prostate Cancer

Study Overview
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Brief Summary
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To compare the efficacy of both strategies (reference treatment: Docetaxel+Prednisone and experimental treatment: Docetaxel+Estramustine+Hydrocortisone) by means of PSA values. To determine the time to treatment failure in both strategies To determine the overall and specific cause survival To evaluate the safety profile To analyze the Quality of Life

Official Title
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Combination of Docetaxel + Estramustine + Hydrocortisone Versus Docetaxel + Prednisone in Patients With Advanced Prostate Cancer Who Have Relapse in Biochemistry Whilst Androgenic Blockage

Conditions
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Prostatic Neoplasms

Intervention / Treatment
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* Drug: Docetaxel + Estramustine + Hydrocortisone
* Drug: Docetaxel + Prednisone


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Histological or cytological confirmation of prostate adenocarcinoma Advanced prostate carcinoma. Previous treatment with hormones Levels of testosterone < 50 ng/dL Good hematological, liver and kidney function Previous treatment with surgery or radiotherapy, at least 4 weeks since end of treatment is allowed (the patient should have been recovered from any side effects. Exclusion Criteria: Previous chemotherapy (estramustine included). Second line hormonotherapy (oestrogens, gestagens, ketoconazole, ...included) Previous treatment with radiotherapy (isotopes) or previous radiotherapy over > 25% of the marrow Any malignant process with a free disease interval under 5 years, exception done to non-melanoma skin cancer. Concomitant serious diseases Concomitant treatment with any other neoplassic therapy (exception done to LHRH agonists and/or biphosphonates). Contraindication for the treatment with estramustine. Previous history of pulmonary embolism, thromboembolic disease, previous treatment with anticoagulants (except aspirin), active thrombophlebitis or hypercoagulation. Previous history of pulmonary spillage or ascitis. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Docetaxel + Estramustine + Hydrocortisone | Drug: Docetaxel + Estramustine + Hydrocortisone<br>* Docetaxel iv 80 mg + Oral estramustine-pills 140 mg + Oral hydrocortisone-pills 20 mg. Combination of these 3 drugs every 3 weeks<br>|
| Active Comparator: 2<br>Docetaxel + Prednisone | Drug: Docetaxel + Prednisone<br>* Docetaxel iv 80 mg + oral prednisone-pills 5 mg. Combination of these 2 drugs every 3 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate over 50% in PSA |  | every 3 weeks up to end of treatment and every month until PSA progression | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to treatment failure |  | from Informed Consent signature up to end of the study | 
| Time to progression |  | from Informed Consent signature up to study end | 
| Overall and specific cause surveillance |  | from Informed Consent signature up to study end | 
| Toxicity profile |  | from Informed Consent signature up to study end | 
| Patients' Quality of Life |  | Before first cycle, every 2 cycles throughout the treatment period, at the study end and first follow-up visit |