Docetaxel and Prednisone in Treating Patients With Hormone-Refractory Metastatic Prostate Cancer

DISEASE CHARACTERISTICS:

• Histologically or cytologically confirmed adenocarcinoma of the prostate

  • Metastatic disease by imaging or clinical examination
• Hormone-refractory disease, defined as prostate-specific antigen (PSA) level > 10 µg/L AND rising between 2 sequential measurements
• Testosterone within castration levels by orchiectomy or medical castration comprising luteinizing hormone-releasing hormone (LHRH) analogues

PATIENT CHARACTERISTICS:

Age

• Over 18

Performance status

• WHO 0-2

Life expectancy

• Not specified

Hematopoietic

• Neutrophil count ≥ 1,500/mm^3
• Hemoglobin ≥ 11.0 g/dL
• Platelet count ≥ 100,000/mm^3

Hepatic

• ALT and AST ≤ 2.5 times upper limit of normal (ULN)
• Bilirubin normal
• Alkaline phosphatase ≤ 6 times ULN (unless due to the presence of extensive bone disease)
• No serious liver disease

Renal

• Creatinine ≤ 1.5 times ULN

Cardiovascular

• No ischemic or thromboembolic cardiac disease
• No myocardial infarction within the past 12 months
• No other serious cardiac disease

Pulmonary

• No pulmonary emboli

Immunologic

• No active infection

• No autoimmune disease, including any of the following:

  • Lupus
  • Scleroderma
  • Rheumatoid polyarthritis

Other

• No active peptic ulcer
• No unstable diabetes mellitus
• No contraindication to corticosteroids
• No other malignant disease within the past 5 years except basalioma
• No functional iron deficiency (i.e., transferrin saturation < 20%) that cannot be treated with iron supplementation
• No other serious illness or medical condition

PRIOR CONCURRENT THERAPY:

Biologic therapy

• More than 2 months since prior recombinant human epoetin alfa or any other erythropoiesis-stimulating drug

Chemotherapy

• At least 3 weeks since prior estramustine

Endocrine therapy

• See Disease Characteristics
• At least 3 weeks since prior antiandrogen treatment

• Concurrent chemical castration with LHRH allowed provided patient has begun treatment prior to study entry

  • No initiation of chemical castration therapy during study treatment

Radiotherapy

• No prior radiotherapy to > 25% of bone marrow
• No prior radioisotope therapy
• Concurrent local palliative radiotherapy for pain allowed

Surgery

• See Disease Characteristics
• At least 4 weeks since prior surgery

Other

• No other prior cytostatic treatment

• Concurrent bisphosphonates allowed provided patient has begun treatment prior to study entry

  • No initiation of bisphosphonates during study treatment