A Phase II Trial of Leuprolide + Flutamide + Suramin in Untreated Poor Prognosis Prostate Carcinoma

Inclusion Criteria

• •Patients must have a histologic diagnosis of carcinoma of the prostate and must not have had a trial of hormonal therapy or chemotherapy.
• •Patients must be 18 years of age and an SGOT/SGPT within 2 times of normal.
• •Patients must have stage D2 prostate carcinoma or State D1 disease with a Gleason grade 7 or above (poorly differentiated).
• •No other malignancy except curatively treated basal cell cancer of the skin.
• •Performance status ECOG of 0-3.
• •Ability to give informed consent.
• •No history of cerebrovascular event, either thrombotic or hemorrhagic.
• •No current clinical signs of congestive heart failure, angina pectoris or myocardial infarction. Patient cannot be on calcium channel blockers such as Nifedipine, Diltiazem, or Verapamil.
• •No clinical or radiographic evidence of brain metastases.
• •Patients with extensive liver replacement (greater than 50%) by tumor will be ineligible.
• •Patients must have a creatinine lest than or equal 2.5 mg/dl or creatinine clearance of greater than or equal to 40 ml/min.
• •Patients must have adequate hepatic function (bilirubin less than 1.5mg%).
• •If the patient has white cells in his urinalysis or other evidence of a urinary tract infection, this must be evaluated and appropriate therapy initiation prior to the initiation of therapy.
• •Patients must not have received chemotherapy.
• •An absolute granulocyte count greater than 1,500; platelet count greater than 100,000; Fibrinogen greater than 200 mg/dl; Hgb greater than or equal to 9 gm/dl.
• •Reliability of the patient to take oral medication, go home and return for follow-up and treatment.