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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT01325311
First received: March 23, 2011
Last updated: July 21, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Adenocarcinoma of the Prostate
Stage I Prostate Cancer
Stage IIA Prostate Cancer
Stage IIB Prostate Cancer
Drug: cholecalciferol
Drug: genistein
Other: placebo
Other: laboratory biomarker analysis
Other: pharmacological study
Phase 2

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

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:
  • Tissue levels of calcitriol between the placebo and cholecalciferol/genistein arms [ Time Frame: At day 35 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Levels of calcitriol on down-stream related biomarkers and related mechanistic pathways in blood and tissue [ Time Frame: Baseline and at day 35 ] [ Designated as safety issue: No ]
    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.


Enrollment: 50
Study Start Date: December 2011
Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm I (cholecalciferol, genistein)
Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Drug: cholecalciferol
Given PO
Other Names:
  • Calciol
  • Vitamin D3
Drug: genistein
Given PO
Other Names:
  • CI 75610
  • genisteol
  • genisterin
  • prunetol
  • sophoricol
Other: laboratory biomarker analysis
Correlative studies
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies
Placebo Comparator: Arm II (placebo)
Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.
Other: placebo
Given PO
Other Name: PLCB
Other: laboratory biomarker analysis
Correlative studies
Other: pharmacological study
Correlative studies
Other Name: pharmacological studies

Detailed 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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01325311

Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Maryland
Johns Hopkins University/Sidney Kimmel Comprehensive Cancer Center
Baltimore, Maryland, United States, 21287
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital
Baltimore, Maryland, United States, 21231
United States, Massachusetts
Lahey Hospital and Medical Center
Burlington, Massachusetts, United States, 01805
United States, Minnesota
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States, 55455
Minneapolis Veterans Medical Center
Minneapolis, Minnesota, United States, 55417
University of Minnesota Medical Center-Fairview
Minneapolis, Minnesota, United States, 55455
United States, New York
University of Rochester
Rochester, New York, United States, 14642
United States, Oklahoma
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, United States, 73104
United States, South Carolina
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States, 29572
United States, Texas
Urology San Antonio Research PA
San Antonio, Texas, United States, 78229
United States, Wisconsin
University of Wisconsin Hospital and Clinics
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
Investigators
Principal Investigator: David Jarrard University of Wisconsin Hospital and Clinics
  More Information

No publications provided

Responsible Party: National Cancer Institute (NCI)
ClinicalTrials.gov Identifier: NCT01325311     History of Changes
Other Study ID Numbers: NCI-2013-00451, NCI-2013-00451, UWI09-14-01, CDR0000698228, CO-10805, CO 10805, UWI09-14-01, N01CN35153, P30CA014520
Study First Received: March 23, 2011
Last Updated: July 21, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Adenocarcinoma
Prostatic Neoplasms
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases
Cholecalciferol
Genistein
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Bone Density Conservation Agents
Phytoestrogens
Estrogens, Non-Steroidal
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anticarcinogenic Agents
Protective Agents
Antineoplastic Agents
Therapeutic Uses
Protein Kinase Inhibitors
Enzyme Inhibitors

ClinicalTrials.gov processed this record on July 28, 2014