Cholecalciferol and Genistein Before Surgery in Treating Patients With Early Stage Prostate Cancer

Prostate Adenocarcinoma Clinical Trial

Official title:

Phase IIA, Randomized Placebo-Controlled Trial of Single High Dose Cholecalciferol and Daily Genistein (G-2535) Versus Placebo in Men With Early Stage Prostate Cancer Undergoing Prostatectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01325311
• Other study ID #: NCI-2013-00451
• Secondary ID: NCI-2013-00451UW
• Status: Completed
• Phase: Phase 2
• First received: March 23, 2011
• Last updated: August 26, 2015
• Start date: December 2011

Study information

• Verified date: August 2014
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adenocarcinoma
• Prostate Adenocarcinoma
• Prostatic Neoplasms
• Stage I Prostate Cancer
• Stage IIA Prostate Cancer
• Stage IIB Prostate Cancer

Intervention

Drug:
• Cholecalciferol
Given PO
• Genistein
Given PO

Other:
• Laboratory Biomarker Analysis
Correlative studies
• Pharmacological Study
Correlative studies
• Placebo
Given PO

Locations

Country	Name	City	State
United States	Johns Hopkins University/Sidney Kimmel Cancer Center	Baltimore	Maryland
United States	Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital	Baltimore	Maryland
United States	University of Alabama at Birmingham Cancer Center	Birmingham	Alabama
United States	Lahey Hospital and Medical Center	Burlington	Massachusetts
United States	University of Wisconsin Hospital and Clinics	Madison	Wisconsin
United States	Minneapolis Veterans Medical Center	Minneapolis	Minnesota
United States	University of Minnesota Medical Center-Fairview	Minneapolis	Minnesota
United States	Carolina Urologic Research Center	Myrtle Beach	South Carolina
United States	University of Oklahoma Health Sciences Center	Oklahoma City	Oklahoma
United States	University of Rochester	Rochester	New York
United States	Urology San Antonio Research PA	San Antonio	Texas

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tissue levels of calcitriol between the placebo and cholecalciferol/genistein arms	Using the Student t-test. If the normality assumption is tenuous, an appropriate transformation of the data such as logarithm will be considered for Student t-test or a nonparametric test such as Wilcoxon rank-sum test will be used for comparison.	At day 35	No
Secondary	Levels of calcitriol on down-stream related biomarkers and related mechanistic pathways in blood and tissue	Using Student t-test. If the normality assumption is tenuous, an appropriate transformation of the data such as logarithm will be considered for Students t-test or a nonparametric test such as Wilcoxon rank-sum test will be used for comparison.	Baseline and at day 35	No