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

Inclusion Criteria

• •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.