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.

Condition	Treatment or Intervention	Phase
adenocarcinoma of the prostate recurrent prostate cancer stage IV prostate cancer	Drug: docetaxel  Drug: goserelin  Procedure: ablative endocrine surgery  Procedure: antiandrogen therapy  Procedure: chemotherapy  Procedure: endocrine therapy  Procedure: hormone therapy  Procedure: orchiectomy  Procedure: releasing factor agonist therapy	Phase III

Further Study Details: 

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.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

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

France
      Centre Antoine Lacassagne, Nice,  06189,  France; Recruiting
      Centre Eugene Marquis, Rennes,  35042,  France; Recruiting
      Centre Hospital Regional Universitaire de Limoges, Limoges,  87042,  France; Recruiting
      Centre Hospitalier Departemental, La Roche-sur-Yon,  85025,  France; Recruiting
      Centre Leon Berard, Lyon,  69008,  France; Recruiting
      Centre Medico-Chirurgical Foch, Suresnes,  92151,  France; Recruiting
      Centre Paul Papin, Angers,  49100,  France; Recruiting
      Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle, Montpellier,  34298,  France; Recruiting
      Centre Regional Francois Baclesse, Caen,  14076,  France; Recruiting
      Centre Rene Huguenin, Saint Cloud,  92211,  France; Recruiting
      CHU de la Timone, Marseille,  13385,  France; Recruiting
      Clinique D'Occitanie, Muret,  31600,  France; Recruiting
      Clinique Du Parc, Toulouse,  31400,  France; Recruiting
      Clinique Sainte-Marguerite, Hyeres,  83400,  France; Recruiting
      CRLCC Nantes - Atlantique, Nantes-Saint Herblain,  44805,  France; Recruiting
      Hopital Europeen Georges Pompidou, Paris,  75015,  France; Recruiting
      Hopital Notre-Dame de Bon Secours, Metz,  57038,  France; Recruiting
      Hopital Saint Andre, Bordeaux,  33075,  France; Recruiting
      Institut Claudius Regaud, Toulouse,  31052,  France; Recruiting
      Institut Curie - Section Medicale, Paris,  75248,  France; Recruiting
      Institut Gustave Roussy, Villejuif,  F-94805,  France; Recruiting
      Institut J. Paoli and I. Calmettes, Marseille,  13273,  France; Recruiting
      Institut Jean Godinot, Reims,  51056,  France; Recruiting
      Polyclinique du Parc, Cholet,  49300,  France; Recruiting

Study chairs or principal investigators

Gwenaelle Gravis, MD,  Study Chair,  Institut J. Paoli and I. Calmettes   

Study ID Numbers:  CDR0000416096; FRE-FNCLCC-GETUG-15/0403; NCT00104715
Record last reviewed:  February 2005
Last Updated:  April 4, 2005
Record first received:  March 3, 2005
ClinicalTrials.gov Identifier:  NCT00104715
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08