Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Isoflavones Compared With Lycopene Before Surgery in Treating Patients With Stage I or Stage II Prostate Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Biomarker/Laboratory analysis, Treatment	Completed	45 to 80	NCI	MCC-0105 NCI-3811, NCI-P02-0216, HLMCC 0105, NCT00042731

Objectives

1. 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.
2. Compare the effects of these nutritional supplements on increases in plasma levels and tissue levels of these agents in these patients.
3. Compare the effects of these nutritional supplements on changes in surrogate markers of disease progression (e.g., prostate-specific antigen levels) in these patients.
4. Compare the effects of these nutritional supplements on changes in serum steroid hormones, estradiol, and free testosterone in these patients.
5. Compare the magnitude of these changes in patients treated with these nutritional supplements vs patients in the control group.

Entry Criteria

Disease Characteristics:

• Histologically confirmed localized prostate cancer
  • Stage I or II



• Scheduled prostatectomy between 4-6 weeks after initial biopsy

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

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

Expected Enrollment

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

Outcomes

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

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

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.

Trial Contact Information

Trial Lead Organizations

H. Lee Moffitt Cancer Center CCOP Research Base

Nagi Kumar, PhD, RD, FADA, Protocol chair		Ph: 813-745-6885; 888-663-3488

Registry Information
Official Title		A Randomized Pilot Clinical Trial Of The Action Of Isoflavones And Lycopene In Localized Prostate Cancer: Administration Prior To Radical Prostatectomy
Trial Start Date		2002-08-23
Trial Completion Date		2006-08-02
Registered in ClinicalTrials.gov		NCT00042731
Date Submitted to PDQ		2002-01-29
Information Last Verified		2006-08-03

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