Prostate Adenocarcinoma TransCutaneous Hormones

Inclusion Criteria

• •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