Isoflavones Compared With Lycopene Before Surgery in Treating Patients With Stage I or Stage II Prostate Cancer - Full Text View

Sponsors and Collaborators:	H. Lee Moffitt Cancer Center and Research Institute National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00042731

Purpose

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.

Condition	Intervention
Prostate Cancer	Dietary Supplement: lycopene Dietary Supplement: multivitamin Dietary Supplement: soy isoflavones Other: laboratory biomarker analysis Procedure: neoadjuvant therapy

Study Type:

Interventional

Study Design:

Treatment, Randomized, Active Control

Official Title:

A Randomized Pilot Clinical Trial Of The Action Of Isoflavones And Lycopene In Localized Prostate Cancer:

Administration Prior To Radical Prostatectomy

Resource links provided by NLM:

MedlinePlus related topics: Cancer Dietary Supplements Diets Prostate Cancer Surgery

U.S. FDA Resources

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

Primary Outcome Measures:

Effect of isoflavones and lycopene on endpoint biomarkers as measured by tissue cell proliferation, apoptosis, or programmed cell death at prostate cancer biopsy and surgical excision [ Designated as safety issue: No ]

Secondary Outcome Measures:

Plasma levels of isoflavones and lycopene as measured by plasma analysis at baseline and post-study intervention [ Designated as safety issue: No ]
Correlation of plasma and tissue levels of isoflavones and lycopene as measured by plasma and tissue analysis at baseline and post-study intervention [ Designated as safety issue: No ]
Effect of isoflavones and lycopene on markers of disease progression as measured by prostate-specific antigen (PSA) levels at baseline and post-study intervention [ Designated as safety issue: No ]
Effect of isoflavones and lycopene on serum steriod hormones as measured by sex-hormone-binding globulin, estradiol, and free testosterone at baseline and post-study intervention [ Designated as safety issue: No ]

Estimated Enrollment:	87
Study Start Date:	August 2002
Primary Completion Date:	August 2006 (Final data collection date for primary outcome measure)

Detailed Description:

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 arms.

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

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

Eligibility

Ages Eligible for Study:	45 Years to 80 Years
Genders Eligible for Study:	Male
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00042731

Locations

United States, Arizona
CCOP - Western Regional, Arizona
Phoenix, Arizona, United States, 85006-2726
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, United States, 33612-9497
United States, Georgia
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
Savannah, Georgia, United States, 31405-6015
United States, North Dakota
CCOP - MeritCare Hospital
Fargo, North Dakota, United States, 58122
United States, Texas
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508

Sponsors and Collaborators

H. Lee Moffitt Cancer Center and Research Institute

National Cancer Institute (NCI)

Investigators

Study Chair:

Nagi B. Kumar, PhD, RD, FADA

H. Lee Moffitt Cancer Center and Research Institute

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000069265, MCC-0105, NCI-3811, NCI-P02-0216
Study First Received:	August 5, 2002
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00042731 History of Changes
Health Authority:	United States: Federal Government

Keywords provided by National Cancer Institute (NCI):

stage I prostate cancer
stage II prostate cancer

Study placed in the following topic categories:

Anticarcinogenic Agents
Radiation-Protective Agents
Antioxidants
Prostatic Diseases
Genital Neoplasms, Male

Lycopene
Urogenital Neoplasms
Genital Diseases, Male
Prostatic Neoplasms

Additional relevant MeSH terms:

Anticarcinogenic Agents
Radiation-Protective Agents
Antioxidants
Genital Neoplasms, Male
Prostatic Diseases
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Lycopene
Physiological Effects of Drugs

Urogenital Neoplasms
Genital Diseases, Male
Protective Agents
Pharmacologic Actions
Neoplasms
Neoplasms by Site
Therapeutic Uses
Prostatic Neoplasms

ClinicalTrials.gov processed this record on September 10, 2009