Prostate Cancer Clinical Trial
Cholecalciferol and Genistein Before Surgery in Treating Patients With Early Stage Prostate Cancer
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.
Full Description
PRIMARY OBJECTIVES:
I. To determine differences in prostate tissue steady state concentrations of calcitriol in participants treated with a single dose cholecalciferol (200,000 IU) and G-2535 (which provides 600 mg of genistein) and those receiving placebo.
SECONDARY OBJECTIVES:
I. To determine the effect of each intervention arm and resulting prostate tissue levels of calcitriol on down-stream related biomarkers and related mechanistic pathways in blood and tissue.
OUTLINE: Patients are randomized to 1 of 2 treatment arms.
ARM I: Patients receive cholecalciferol orally (PO) on day 1 and genistein PO once daily (QD) on days 1-21 or 1-28. Patients then undergo prostatectomy.
ARM II: Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
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
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There are 11 Locations for this study
Birmingham Alabama, 35233, United States
Baltimore Maryland, 21231, United States
Baltimore Maryland, 21287, United States
Burlington Massachusetts, 01805, United States
Minneapolis Minnesota, 55417, United States
Minneapolis Minnesota, 55455, United States
Rochester New York, 14642, United States
Oklahoma City Oklahoma, 73104, United States
Myrtle Beach South Carolina, 29572, United States
San Antonio Texas, 78229, United States
Madison Wisconsin, 53792, United States
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