Vitamin D and Soy Supplements in Treating Patients With Recurrent Prostate Cancer

You may be eligible if

• Inclusion:
• Age \> 18 years
• Histologically confirmed adenocarcinoma of the prostate
• Biochemical relapse following definitive therapy by ASTRO criteria (PSA with 3 consecutive rising measurements separated by at least one month) and minimum PSA ≥ 1.0 ng/mL
• PSA doubling time of ≥ 6 months, as demonstrated by 3 PSA measurements obtained ≥ 2 months apart
• No hormonal therapy in 6 months prior to enrollment
• ECOG performance status 0-2
• Life expectancy \> 3 months
• At least 2 years since prior definitive radiotherapy
• No concurrent cholecalciferol, calcium, or soy supplements
• Absolute granulocyte count ≥ 1,000/mm³
• Platelet count ≥ 100,000/mm³
• Hemoglobin ≥ 9.0 g/dL
• Creatinine ≤ 2.0 mg/dL
• Total bilirubin ≤ 2.0 mg/dL
• Calcium \> 8.5 mg/dL and \< 10.5 mg/dL
• Testosterone ≥ 150 ng/dL
• Exclusion:
• No clinically evident brain metastases
• Concurrent cholecalciferol, calcium, or soy supplements
• Concurrent chemotherapy with nonstudy drugs
• Serious medical illness that would limit survival to \< 3 months, or psychiatric condition that would preclude giving informed consent
• Other malignancy except nonmelanoma skin cancer, adequately treated stage I or II cancer from which the patient is currently in complete remission, or any other cancer from which the patient has been disease-free for the past 5 years
• Active, uncontrolled bacterial, viral, or fungal infection
• Hemorrhagic disorder
• Evidence of metastatic disease by bone scan or CT scan
• History of hypercalcemia
• More History of exposure to other phytotherapeutics, including PC-SPES and Saw Palmetto, within the last year.