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

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.

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