Hormone Therapy in Treating Patients With Locally Advanced or Metastatic Prostate Cancer

DISEASE CHARACTERISTICS:

• Must meet 1 of the following criteria:

  • Newly diagnosed patients with any of the following:

    • Stage T3 or T4, NX, M0 histologically confirmed prostate adenocarcinoma with prostate-specific antigen (PSA) ≥ 20 ng/mL or Gleason score ≥ 6
    • Any T, N+, M0, or any T, any N, M+ histologically confirmed prostate adenocarcinoma
    • Multiple sclerotic bone metastases with a PSA ≥ 50 ng/mL without histological confirmation

  • Patients with histologically confirmed prostate adenocarcinoma previously treated with radical surgery or radiotherapy who are currently in relapse with on of the following:

    • PSA ≥ 4 ng/mL and rising with doubling time less than 6 months
    • PSA ≥ 20 ng/mL
• Must have written informed consent
• Intention to treat with long-term androgen-deprivation therapy
• Normal testosterone level prior to hormonal treatment

PATIENT CHARACTERISTICS:

• WHO performance status 0-2
• No other prior or current malignant disease or cardiovascular system disease that is likely to interfere with study treatment or assessment

• No cardiovascular disease, including any of the following:

  • History of cerebral ischemia (e.g., stroke or transient ischemic attack) within the past 2 years
  • History of deep vein thrombosis or pulmonary embolism confirmed radiologically

  • History of myocardial infarction (MI) within the past 6 months OR MI more than 6 months ago with evidence of q-wave anterior infarct on ECG

    • ECHO or MUGA required for patients with history of ischemic heart disease
  • Left Ventricular Ejection Fraction ≤ 40%
• No condition or situation that could preclude protocol treatment or compliance with follow-up schedule

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics
• At least 12 months since prior adjuvant or neoadjuvant hormonal therapy for localized prostate cancer AND therapy lasted ≤ 12 months in duration
• No prior systemic therapy for locally advanced or metastatic prostate cancer
• No concurrent participation in another clinical trial of prostate cancer treatment that would preclude study therapy or outcome measures
• Concurrent prophylactic radiotherapy to prevent gynecomastia allowed