Hormone Therapy With or Without Squalamine Lactate in Treating Patients Who Are Undergoing a Radical Prostatectomy for Locally Advanced Prostate Cancer
Prostate Cancer
About this trial
This is an interventional treatment trial for Prostate Cancer focused on measuring adenocarcinoma of the prostate, stage III prostate cancer
Eligibility Criteria
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the prostate Locally advanced disease No metastatic disease High-risk characteristics, meeting ≥ 1 of the following criteria: Large, hard tumor on digital exam Aggressive-appearing cancer cells on biopsy Prostate-specific antigen > 10 ng/mL PATIENT CHARACTERISTICS: Performance status 0-1 Life expectancy Not specified Hematopoietic WBC > 1,500/mm^3 Platelet count > 100,000/mm^3 Hemoglobin > 11.0 g/dL Hepatic Bilirubin < 2 times upper limit of normal (ULN) SGOT and SGPT < 2 times ULN PT and PTT normal Renal Creatinine < 1.8 g/dL Cardiovascular No history of ventricular arrhythmia or dysfunction No congestive heart failure No symptomatic coronary artery disease No prior myocardial infarction No history of thromboembolic disease (e.g., deep vein thrombosis or stroke) within the past 12 months No other significant cardiovascular disease Pulmonary No pulmonary embolism within the past 12 months No exercise-limiting respiratory disease Other Fertile patients must use effective barrier method contraception No sexual intercourse for 6 weeks after surgery No uncontrolled diabetes No serious acute infection No other malignancy except nonmelanoma skin cancer PRIOR CONCURRENT THERAPY: Biologic therapy No prior squalamine lactate Chemotherapy No prior chemotherapy for prostate cancer No concurrent anticancer chemotherapy Endocrine therapy No concurrent systemic corticosteroids Radiotherapy No prior radiotherapy for prostate cancer No concurrent radiotherapy Surgery No prior surgery for prostate cancer No other concurrent surgery Other At least 6 weeks since prior and no concurrent use of over-the-counter or herbal drugs that have estrogenic activity No participation in another investigational study within the past 3 months No concurrent participation in another investigational study