Isoflavones and Radiation Therapy in Treating Patients Wi... | NCT00243048

Studies
Isoflavones and Radiation Therapy in Treating Patients With Localized Prostate Cancer

NCT00243048

Sponsor

Barbara Ann Karmanos Cancer Institute

Status

Completed

Last Update Posted

Apr 5, 2013Estimated

Enrollment

70Estimated

Phase

Phase 2

Conditions

Prostate Cancer

Interventions

soy protein isolate
radiation therapy

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
P30CA022453	U.S. NIH Grant/Contract		View source
WSU-D-2325

Status Module

Record Verification Date

Apr 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2002

Primary Completion Date

Oct 2006Actual

Completion Date

Oct 2007Actual

First Submitted Date

Oct 20, 2005

First Submission Date that Met QC Criteria

Oct 20, 2005

First Posted Date

Oct 21, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 3, 2013

Last Update Posted Date

Apr 5, 2013Estimated

Name	Class
National Cancer Institute (NCI)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

RATIONALE: Eating a diet high in soy foods may slow the progression of some types of cancer. Isoflavones are compounds found in soy food that may slow the growth of prostate cancer cells and prevent further development of prostate cancer. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving isoflavones together with radiation therapy may be an effective treatment for prostate cancer.

PURPOSE: This randomized phase II trial is studying the side effects and how well giving isoflavones together with radiation therapy works in treating patients with localized prostate cancer.

Detailed Description

OBJECTIVES:

Determine the effect of soy protein isolate (isoflavones) and radiotherapy on the modulation of biomarkers in patients with localized prostate cancer.
Determine the toxicity of this regimen in these patients.
Determine the effect of this regimen on the quality of life of these patients.

OUTLINE: This is a randomized, placebo-controlled study. Patients are randomized to 1 of 2 treatment arms.

Arm I: Patients receive oral soy protein isolate (isoflavones) twice daily for 6 months in the absence of disease progression or unacceptable toxicity.
Arm II: Patients receive an oral placebo twice daily for 6 months in the absence of disease progression or unacceptable toxicity.

In both arms, patients also undergo radiotherapy while receiving isoflavones or placebo.

Quality of life is assessed periodically.

PROJECTED ACCRUAL: A total of 70 patients will be accrued for this study.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

70Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Oxidative DNA damage at 3 and 6 months

Secondary Outcomes

Measure	Description	Time Frame
Quality of life as measured by questionnaire at 3 and 6 months
Toxicity as measured by number and grade of adverse events weekly during radiation and at 3 and 6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed adenocarcinoma of the prostate that is localized to the prostate gland
Must be scheduled to receive curative radiotherapy for prostate cancer
Not eligible for a higher priority study at the Karmanos Cancer Institute

PATIENT CHARACTERISTICS:

Performance status

Life expectancy

Not specified

Hematopoietic

Not specified

Hepatic

Not specified

Renal

Not specified

Other

No organ function restrictions

PRIOR CONCURRENT THERAPY:

Chemotherapy

No prior chemotherapy

Endocrine therapy

No prior hormonal therapy

Radiotherapy

See Disease Characteristics

Other

No other concurrent micronutrient supplements, herbs, or vitamins except 1 daily multivitamin

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Affiliation	Role
Omer Kucuk, MD	Barbara Ann Karmanos Cancer Institute	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Barbara Ann Karmanos Cancer Institute		Detroit	Michigan	48201-1379	United States

ID	Term
D011471	Prostatic Neoplasms

ID	Term
D005834	Genital Neoplasms, Male
D014565	Urogenital Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms

Intervention Browse Module

MeSH Terms

ID	Term
D030262	Soybean Proteins
D011878	Radiotherapy

Ancestor Terms

ID	Term
D010940	Plant Proteins
D011506	Proteins
D000602	Amino Acids, Peptides, and Proteins
D014674	Plant Proteins, Dietary

Browse Leaves

Not provided

Browse Branches

Not provided

Name	Type	Description	Arm Group Labels	Other Names
soy protein isolate	Dietary Supplement
radiation therapy	Radiation