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

Prostate Cancer Clinical Trial

Official title:

A Randomized Pilot Clinical Trial Of The Action Of Isoflavones And Lycopene In Localized Prostate Cancer: Administration Prior To Radical Prostatectomy

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00042731
• Other study ID #: MCC-13004
• Secondary ID: NCI-3811NCI-P02-
• Status: Completed
• Phase: N/A
• First received: August 5, 2002
• Last updated: September 21, 2012
• Start date: July 2002
• Est. completion date: August 2006

Study information

• Verified date: September 2012
• Source: H. Lee Moffitt Cancer Center and Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial Summary

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.

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 groups.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: August 2006
• Est. primary completion date: August 2006
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 45 Years to 80 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Dietary Supplement:
• Lycopene
Daily administration as outlined in treatment arm(s)
• Multivitamin
Daily administration as outlined in treatment arm(s)
• Soy isoflavones
Daily administration as outlined in treatment arm(s)

Locations

Country	Name	City	State
United States	CCOP - MeritCare Hospital	Fargo	North Dakota
United States	CCOP - Western Regional, Arizona	Phoenix	Arizona
United States	Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler	Savannah	Georgia
United States	H. Lee Moffitt Cancer Center and Research Institute	Tampa	Florida
United States	CCOP - Scott and White Hospital	Temple	Texas

Sponsors (2)

Lead Sponsor	Collaborator
H. Lee Moffitt Cancer Center and Research Institute	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	4 years	No
Secondary	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	4 years	No
Secondary	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	4 years	No
Secondary	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	4 years	No
Secondary	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	4 years	No