Hormone Therapy With or Without Docetaxel And Estramustine in Treating Patients With Prostate Cancer That is Locally Advanced or At High Risk of Relapse

Study Overview
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Brief Summary
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RATIONALE: Androgens can stimulate the growth of prostate cancer cells. Drugs such as nilutamide, bicalutamide, flutamide, or cyproterone may stop the adrenal glands from producing androgens. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. It is not yet known whether hormone therapy is more effective with or without chemotherapy in treating prostate cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of hormone therapy with or without docetaxel and estramustine in treating patients who have prostate cancer that is locally advanced or at high risk of relapse.

Official Title
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Phase III Randomized Study Of Adjuvant Hormonal Therapy With And Without Docetaxel And Estramustine In Patients With Advanced Prostate Cancer Or With A High Risk Of Relapse

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: bicalutamide
* Drug: Goserelin Acetate
* Drug: docetaxel
* Drug: Estramustine phosphate sodium
* Drug: acetylsalicylic acid
* Procedure: conventional surgery
* Radiation: radiation therapy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate Locally advanced disease or at high risk for relapse No clinically or radiologically suspected metastases Prior lymphadenectomy required Meets at least 1 of the following criteria for poor prognosis: Gleason score greater than 7 T3 or T4 disease Prostate-specific antigen greater than 20 ng/mL N1 disease PATIENT CHARACTERISTICS: Age Under 80 Performance status ECOG 0-2 Life expectancy More than 10 years Hematopoietic Absolute neutrophil count greater than 1,500/mm^3 Platelet count at least 100,000/mm^3 Hepatic AST and ALT no greater than 1.5 times upper limit of normal (ULN) Bilirubin no greater than ULN Renal Creatinine less than 1.6 mg/dL OR Creatinine clearance greater than 60 mL/min Cardiovascular No uncontrolled or severe cardiovascular disease No prior thrombosis Pulmonary No prior pulmonary embolus Other No active infection No intolerance to aspirin No other prior malignancy except basal cell skin cancer No physical or psychological condition that would preclude study compliance PRIOR CONCURRENT THERAPY: Biologic therapy No concurrent immunotherapy Chemotherapy No prior chemotherapy No other concurrent chemotherapy Endocrine therapy No prior hormonal therapy No other concurrent hormonal therapy Radiotherapy Not specified Surgery See Disease Characteristics Other No other concurrent anticancer therapy

Ages Eligible for Study
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Minimum Age: 0 Years
Maximum Age: 79 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: Chemotherapy<br> | Drug: bicalutamide<br> <br> * Other names: CASODEX®;Drug: Goserelin Acetate<br> <br> * Other names: ZOLADEX®;Drug: docetaxel<br> <br> Drug: Estramustine phosphate sodium<br> <br> Drug: acetylsalicylic acid<br> <br> * Other names: Aspirin;Procedure: conventional surgery<br> <br> Radiation: radiation therapy<br> <br> |
| Active Comparator: Without Chemotherapy<br> | Drug: bicalutamide<br> <br> * Other names: CASODEX®;Drug: Goserelin Acetate<br> <br> * Other names: ZOLADEX®;Procedure: conventional surgery<br> <br> Radiation: radiation therapy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | The progression-free survival is the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse. | From randomization to disease progression or death, up to 15 years. | 
| Biological response: Prostate-specific antigen (PSA) level | The biological response is defined as a non-detectable serum PSA level (<0.1 ng/ml) | 3 months | 
| Cancer progression as measured by ultrasound | Defined as a decrease of at least 20% in prostate volume detected by ultrasound after the neo-adjuvant treatment | From randomization to disease progression, up to 15 years. | 
| Clinical progression-free survival | The clinical progression-free survival is the length of time during and after the treatment of a disease that a patient lives with the disease but it does not get worse (based on bone scintigraphy, pelvic scan, or MRI evaluation). | From randomization to disease progression or death, up to 15 years. | 
| Overall survival | The overall survival is the length of time from randomization that patients enrolled in the study are still alive. The outcome is to evaluate whether SRBT improves overall survival compared to standard of care. | From randomization to death from any cause, up to 15 years. | 
| Acute and late toxicity during the study | The National Cancer Institute-Common Terminology Criteria for Adverse Events version 4.0 (NCI-CTCAE v4.0) is widely accepted in the community of oncology research as the leading rating scale for adverse events. This scale, divided into 5 grades (1 = mild, 2 = moderate, 3 = severe, 4 = life-threatening, and 5 = death) determined by the investigator, will make it possible to assess the severity of the disorders. | Throughout study completion, up to 15 years. | 
| Quality of life questionnaire - Core 30 (QLQ-C30) | Developed by the EORTC, this self-reported questionnaire assesses the health-related quality of life of cancer patients in clinical trials. The questionnaire includes five functional scales (physical, everyday activity, cognitive, emotional, and social), three symptom scales (fatigue, pain, nausea and vomiting), a health/quality of life overall scale, and a number of additional elements assessing common symptoms (including dyspnea, loss of appetite, insomnia, constipation, and diarrhea), as well as, the perceived financial impact of the disease. All of the scales and single-item measures range in score from 0 to 100. A high scale score represents a higher response level. | At baseline, 3 months, and 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage III prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer