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

NCT01325311 | Completed Phase 2 Results DMC

• 7 other identifiers: NCI-2013-00451UWI09-14-01CDR0000698228CO-10805CO 10805N01CN35153P30CA014520
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 11

Brief 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.

Conditions

Prostate Adenocarcinoma; Stage I Prostate Cancer; Stage IIA Prostate Cancer; Stage IIB Prostate Cancer

Outcome Measures

Primary Outcomes (2)

• Tissue Levels of Calcitriol Between the Placebo and Cholecalciferol/Genistein Arms

  This is a measure of calcitriol in prostate tissue comparing placebo and cholecalciferol/genistein

  up to Day 35

• Detectability of Calcitriol Levels in Tissue Between the Placebo and Cholecalciferol/Genistein Arms

  To identify the amount of Calcitriol that is found in the tissue comparing Placebo and Cholecalciferol/Genistein

  up to 35 days

Secondary Outcomes (13)

• Levels of Calcidiol in the Participants Serum

  Baseline and up to day 35

• Levels of Calcitriol in Participants Serum

  baseline and Up to Day 35

• PBMC CYP mRNA Expression of CYP24

  Baseline and Up to Day 35

• PBMC CYP mRNA Expression of CYP27B1

  Up to Day 35

• Total PSA in Serum

  at Baseline and up to Day 35

Study Arms (2)

Arm I (cholecalciferol, genistein)

EXPERIMENTAL

Patients receive cholecalciferol PO on day 1 and genistein PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.

Drug: Cholecalciferol; Drug: Genistein; Other: Laboratory Biomarker Analysis; Other: Pharmacological Study

Arm II (placebo)

PLACEBO COMPARATOR

Patients receive placebo PO on day 1 and placebo PO QD on days 1-21 or 1-28. Patients then undergo prostatectomy.

Other: Laboratory Biomarker Analysis; Other: Pharmacological Study; Other: Placebo

Interventions

Cholecalciferol DRUG

Given PO

Also known as: 9,10-Secocholesta-5,7,10(19)-trien-3-ol, Calciol, Delsterol, Vitamin D3

Arm I (cholecalciferol, genistein)

Genistein DRUG

Given PO

Also known as: 4',5, 7-Trihydroxyisoflavone, Genestein, Genisteol, Prunetol

Arm I (cholecalciferol, genistein)

Laboratory Biomarker Analysis OTHER

Correlative studies

Arm I (cholecalciferol, genistein); Arm II (placebo)

Pharmacological Study OTHER

Correlative studies

Arm I (cholecalciferol, genistein); Arm II (placebo)

Placebo OTHER

Given PO

Also known as: placebo therapy, PLCB, sham therapy

Arm II (placebo)

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Cancer Institute (NCI): lead

Study Sites (11)

University of Alabama at Birmingham Cancer Center

Birmingham, Alabama, 35233, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Hospital

Baltimore, Maryland, 21231, United States

Location

Johns Hopkins University/Sidney Kimmel Cancer Center

Baltimore, Maryland, 21287, United States

Location

Lahey Hospital and Medical Center

Burlington, Massachusetts, 01805, United States

Location

Minneapolis Veterans Medical Center

Minneapolis, Minnesota, 55417, United States

Location

University of Minnesota Medical Center-Fairview

Minneapolis, Minnesota, 55455, United States

Location

University of Rochester

Rochester, New York, 14642, United States

Location

University of Oklahoma Health Sciences Center

Oklahoma City, Oklahoma, 73104, United States

Location

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States

Location

Urology San Antonio Research PA

San Antonio, Texas, 78229, United States

Location

University of Wisconsin Hospital and Clinics

Madison, Wisconsin, 53792, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Cholecalciferol; Genistein

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids; Isoflavones; Flavonoids; Chromones; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Howard H. Bailey
• Organization: University of Wisconsin

hhbailey@wisc.edu

608-263-8624

Study Officials

• David Jarrard

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2011
• First Posted: March 29, 2011
• Study Start: December 1, 2011
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: August 3, 2016
• Results First Posted: August 3, 2016

Record last verified: 2016-06

Locations

US (11)