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

H. Lee Moffitt Cancer Center and Research Institute79 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Prostate Cancer

Interventions

LycopeneDIETARY_SUPPLEMENT

Daily administration as outlined in treatment arm(s)

MultivitaminDIETARY_SUPPLEMENT

Daily administration as outlined in treatment arm(s)

Soy isoflavonesDIETARY_SUPPLEMENT

Daily administration as outlined in treatment arm(s)

Eligibility

Sex: MALEMin age: 45 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (5)

CCOP - Western Regional, Arizona

Phoenix, Arizona, United States

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

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

Savannah, Georgia, United States

CCOP - MeritCare Hospital

Fargo, North Dakota, United States

Outcomes

Primary Outcomes

Occurrences of Treatment Effect on Biomarkers in Each Group

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

Time frame: 4 years

Secondary Outcomes

Occurrences of Plasma Level Changes for Each Group

Plasma levels of isoflavones and lycopene as measured by plasma analysis at baseline and post-study intervention

Time frame: 4 years

Occurrence of Tissue Level Increases

Correlation of plasma and tissue levels of isoflavones and lycopene as measured by plasma and tissue analysis at baseline and post-study intervention

Time frame: 4 years

Occurrences of Disease Progression for Each Group

Effect of isoflavones and lycopene on markers of disease progression as measured by prostate-specific antigen (PSA) levels at baseline and post-study intervention

Time frame: 4 years

Occurrences of Hormonal Effect

Effect of isoflavones and lycopene on serum steroid hormones as measured by sex-hormone-binding globulin, estradiol, and free testosterone at baseline and post-study intervention

Time frame: 4 years

Data from ClinicalTrials.gov

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