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Isoflavones & Lycopene in Localized Prostate Ca:Prior to Radical Prostatectomy

NCT ID: NCT00042731

Last Updated: 2012-09-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

79 participants

Study Classification

INTERVENTIONAL

Study Start Date

2002-07-31

Study Completion Date

2006-08-31

Brief Summary

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RATIONALE: Eating a diet rich in isoflavones, compounds found in soy foods, or lycopene, a substance found in tomatoes, may keep prostate cancer from growing. Giving isoflavones or lycopene before surgery may be an effective treatment for prostate cancer.

PURPOSE: Randomized clinical trial to compare the effectiveness of isoflavones with that of lycopene before surgery in treating patients who have stage I or stage II prostate cancer.

Detailed Description

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OBJECTIVES:

* Compare the effect of isoflavones vs lycopene prior to radical prostatectomy on intermediate biomarkers (e.g., indices of cell proliferation and apoptosis) in patients with localized prostate cancer.
* Compare the effects of these nutritional supplements on increases in plasma levels and tissue levels of these agents in these patients.
* Compare the effects of these nutritional supplements on changes in surrogate markers of disease progression (e.g., prostate-specific antigen levels) in these patients.
* Compare the effects of these nutritional supplements on changes in serum steroid hormones, estradiol, and free testosterone in these patients.
* Compare the magnitude of these changes in patients treated with these nutritional supplements vs patients in the control group.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to disease stage (stage I vs stage II) and presence of high-grade prostatic intraepithelial neoplasia. Patients are randomized to 1 of 7 treatment groups.

PROJECTED ACCRUAL: A total of 87 patients will be accrued for this study within 1 year.

Conditions

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Prostate Cancer

Keywords

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stage I prostate cancer stage IIB prostate cancer stage IIA prostate cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Oral isoflavones with multivitamin

Cohorts I - III: Patients receive 1 of 3 doses of oral isoflavones twice daily and a multivitamin once daily. Treatment in all arms continues for 4-6 weeks, until prostatectomy.

Group Type ACTIVE_COMPARATOR

Multivitamin

Intervention Type DIETARY_SUPPLEMENT

Daily administration as outlined in treatment arm(s)

Soy isoflavones

Intervention Type DIETARY_SUPPLEMENT

Daily administration as outlined in treatment arm(s)

Oral lycopene with multivitamin

Cohorts IV-VI: Patients receive 1 of 3 doses of oral lycopene twice daily and a multivitamin once daily. Treatment in all arms continues for 4-6 weeks, until prostatectomy.

Group Type ACTIVE_COMPARATOR

Lycopene

Intervention Type DIETARY_SUPPLEMENT

Daily administration as outlined in treatment arm(s)

Multivitamin

Intervention Type DIETARY_SUPPLEMENT

Daily administration as outlined in treatment arm(s)

Multiple vitamin alone

Patients receive a multivitamin once daily. Treatment in all arms continues for 4-6 weeks, until prostatectomy.

Group Type ACTIVE_COMPARATOR

Multivitamin

Intervention Type DIETARY_SUPPLEMENT

Daily administration as outlined in treatment arm(s)

Interventions

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Lycopene

Daily administration as outlined in treatment arm(s)

Intervention Type DIETARY_SUPPLEMENT

Multivitamin

Daily administration as outlined in treatment arm(s)

Intervention Type DIETARY_SUPPLEMENT

Soy isoflavones

Daily administration as outlined in treatment arm(s)

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

DISEASE CHARACTERISTICS:

* Histologically confirmed localized prostate cancer

* Stage I or II
* Scheduled prostatectomy between 4-6 weeks after initial biopsy

PATIENT CHARACTERISTICS:

Age:

* 45 to 80

Performance status:

* Not specified

Life expectancy:

* Not specified

Hematopoietic:

* Not specified

Hepatic:

* No known history of hepatic disease

Renal:

* No known history of renal disease

Other:

* No known history of thyroid disease
* Body mass index no greater than 32
* Omnivorous diet
* No known allergy to study supplements
* No evidence of prostatitis or urinary tract infection
* No other prior malignancy except nonmelanoma skin cancer
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* Not specified

Endocrine therapy:

* No concurrent thyroid hormone replacement medications

Radiotherapy:

* Not specified

Surgery:

* See Disease Characteristics

Other:

* At least 30 days since prior antibiotics
* At least 30 days since prior diet high in soy and/or lycopene products (e.g., greater than 40 mg soy/day and/or greater than 15 mg lycopene/day)
* No other concurrent nutritional supplements, including modular supplements with other carotenoids and isoflavones
* No prior or concurrent therapy for prostate cancer
Minimum Eligible Age

45 Years

Maximum Eligible Age

80 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nagi B. Kumar, PhD, RD, FADA

Role: STUDY_CHAIR

H. Lee Moffitt Cancer Center and Research Institute

Locations

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CCOP - Western Regional, Arizona

Phoenix, Arizona, United States

Site Status

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Site Status

Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler

Savannah, Georgia, United States

Site Status

CCOP - MeritCare Hospital

Fargo, North Dakota, United States

Site Status

CCOP - Scott and White Hospital

Temple, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-3811

Identifier Type: OTHER

Identifier Source: secondary_id

NCI-P02-0216

Identifier Type: OTHER

Identifier Source: secondary_id

0105

Identifier Type: OTHER

Identifier Source: secondary_id

MCC-13004

Identifier Type: -

Identifier Source: org_study_id