Hormone Therapy and Docetaxel or Hormone Therapy Alone in Treating Patients With Metastatic Prostate Cancer

Study Overview
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Brief Summary
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RATIONALE: Androgens can cause the growth of prostate cancer cells. Drugs, such as goserelin, may stop the adrenal glands from making androgens. Drugs used in chemotherapy, such as docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving hormone therapy together with docetaxel may be an effective treatment for prostate cancer. It is not yet known whether giving hormone therapy together with docetaxel is more effective than hormone therapy alone in treating prostate cancer. PURPOSE: This randomized phase III trial is studying hormone therapy and docetaxel to see how well they work compared to hormone therapy alone in treating patients with metastatic prostate cancer.

Detailed Description
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OBJECTIVES: Compare 36-month overall survival of patients with metastatic prostate adenocarcinoma treated with hormonal therapy and docetaxel vs hormonal therapy alone. Compare 24-month progression-free survival (biological progression and/or clinical progression) in patients treated with these regimens. Compare the quality of life of patients treated with these regimens. Compare costs of these regimens for these patients. Compare the tolerability of these regimens in these patients. Compare the toxicity profile of these regimens in these patients. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive hormonal therapy comprising 1 of the following: goserelin alone OR goserelin and antiandrogen therapy OR surgical castration. Hormonal therapy continues until the development of hormone resistance. Within 2 months after initiation of hormonal therapy, patients receive docetaxel IV every 3 weeks for up to 9 courses in the absence of disease progression or unacceptable toxicity. Arm II: Patients receive hormonal therapy as in arm I. Quality of life is assessed. PROJECTED ACCRUAL: A total of 378 patients will be accrued for this study.

Official Title
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Randomized Phase III Trial Comparing an Association of Hormonal Treatment and Docetaxel Versus the Hormonal Treatment Alone in Metastatic Prostate Cancers

Conditions
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Prostate Cancer

Intervention / Treatment
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* Drug: antiandrogen therapy
* Drug: docetaxel
* Drug: goserelin acetate
* Procedure: orchiectomy


Participation Criteria
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Eligibility Criteria
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DISEASE CHARACTERISTICS: Histologically confirmed prostate adenocarcinoma Metastatic disease Measurable or evaluable disease No brain metastases PATIENT CHARACTERISTICS: Age 18 and over Performance status ECOG 0-2 Life expectancy At least 3 months Hematopoietic WBC ≥ 2,000/mm^3 Absolute neutrophil count ≥ 1,000/mm^3 Platelet count ≥ 100,000/mm^3 Hepatic Bilirubin ≤ 1.5 times upper limit of normal (ULN) (2.5 times normal if hepatic metastases are present) AST and ALT ≤ 1.5 times ULN (2.5 times normal if hepatic metastases are present) Renal Creatinine ≤ 150 μmol/L Cardiovascular No symptomatic coronary disease No congenital cardiac insufficiency No New York Heart Association class III or IV cardiovascular disease No other severe cardiovascular disease Other No severe peripheral neuropathy No active infection No other malignancy within the past 5 years except basal cell skin cancer No familial, social, geographical, or psychological situation that would preclude study compliance and follow-up No other serious disease that would preclude study participation PRIOR CONCURRENT THERAPY: Biologic therapy Not specified Chemotherapy No prior chemotherapy for metastatic prostate cancer Prior chemotherapy allowed provided all of the following are true: Chemotherapy was completed > 1 year ago Prostate-specific antigen level has remained stable No development of metastases within 1 year after completion of chemotherapy Endocrine therapy Prior hormonal therapy within the past 2 months allowed for metastatic prostate cancer Radiotherapy More than 4 weeks since prior radiotherapy to metastatic sites Surgery No prior surgical castration Other No other concurrent investigational drugs

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 120 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: Hormonotherapy + chemotherapy<br> | Drug: antiandrogen therapy<br> <br> Drug: docetaxel<br> <br> Drug: goserelin acetate<br> <br> Procedure: orchiectomy<br> <br> |
| Active Comparator: Hormonotherapy alone<br> | Drug: antiandrogen therapy<br> <br> Drug: goserelin acetate<br> <br> Procedure: orchiectomy<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival at 36 months |  |  | 
| Progression-free survival (biological progression and/or clinical progression) at 24 months |  |  | 
| Quality of life |  |  | 
| Treatment costs |  |  | 
| Toxicity and tolerance |  |  | 
| Tumor profiles of gene expression as measured by biochips with DNA and tissue microarrays |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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adenocarcinoma of the prostate, recurrent prostate cancer, stage IV prostate cancer