Cholecalciferol and Genistein Before Surgery in Treating Patients With Early Stage Prostate Cancer
Condition: Prostate Adenocarcinoma; Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer
MeSH terms: Prostatic Neoplasms
Intervention: Cholecalciferol; Genistein; Laboratory Biomarker Analysis; Pharmacological Study; Placebo
Intervention description: Given PO; Given PO; Correlative studies; Correlative studies; Given PO
Intervention MeSH terms: Vitamin D; Cholecalciferol; Genistein
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 15.0
Sex: Male
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized phase II trial studies cholecalciferol and genistein compared to placebo in
      treating patients with early stage prostate cancer. Cholecalciferol and genistein may slow
      the growth of cancer cells and may be an effective treatment for prostate cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants must have microscopic confirmation of adenocarcinoma of the prostate
             within three months of randomization; clinical stage T1 and T2 a, b, or c are allowed

          -  Participants' prostate cancer must be confined to the prostate (in the clinical
             judgment of the treating physician)

          -  Participants must be candidates for prostatectomy

          -  Participants must have Eastern Cooperative Oncology Group (ECOG) performance status
             =<1 (Karnofsky >= 70%)

          -  White blood cell (WBC) within normal limits

          -  Platelets >= 100 K/uL

          -  Hemoglobin >= 10 g/dL

          -  Thyroid-stimulating hormone (TSH) =< 4.20 uIU/mL

          -  Free T4 =< 12.5 ng/dL

          -  Bilirubin within upper limit of normal

          -  Aspartate aminotransferase (AST) =< 1.5 x upper limit of normal

          -  Creatinine =< 2.0 mg/dL

          -  Serum calcium: within institutional normal limits

          -  Participants must agree to stop taking nonsteroidal anti-inflammatory drugs (NSAIDS)
             during the course of the study, however, low dose aspirin (< 100 mg/day) will be
             allowed; no wash out period is required

          -  Participants must be willing to discontinue consuming soy products and ingesting
             vitamin supplements while participating in this study

          -  The effects of cholecalciferol and genistein on the developing human fetus at the
             recommended therapeutic doses are unknown; for this reason, participants must agree to
             use adequate contraception (hormonal or barrier method of birth control; abstinence)
             for the duration of study participation

          -  Participants must have the ability to understand and sign a consent form indicating
             the investigational nature of the treatment and its potential risks

        Exclusion Criteria:

          -  Participants may not have received any prior therapy for prostate cancer including:
             chemotherapy, hormonal therapy, brachytherapy, or external radiation

          -  Participants may not be receiving concurrent systemic therapy for other cancers

          -  Participants may not be receiving any other investigational agents

          -  Participants may not be taking the following p450 inducers and inhibitors:
             carbamazepine, clarithromycin, fluconazole, fosphenytoin, itraconazole, ketoconazole,
             phenobarbital, phenytoin, rifabutin, rifampin

          -  Participants who took finasteride or dutasteride within 6 months of the
             pre-randomization biopsy, are currently taking finasteride or dutasteride, or are
             planning on taking these agents during study participation

          -  Participants with a history of allergic reactions attributed to genistein or placebo,
             or compounds of similar chemical or biologic composition

          -  Participants with uncontrolled intercurrent illness including, but not limited to
             ongoing or active infection, symptomatic congestive heart failure, unstable angina
             pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would
             limit compliance with study requirements

          -  Participants requires thyroid replacement therapy; Note: participants with a history
             of thyroid disease > 5 years ago, with current normal thyroid function, will be
             considered eligible

          -  Participant has current, known nephrolithiasis or a history of nephrolithiasis within
             the past 5 years

          -  Participant has any history of sarcoidosis