A Randomized Pilot Clinical Trial Of The Action Of Isoflavones And Lycopene In Localized Prostate Cancer: Administration Prior To Radical Prostatectomy
45 Years
80 Years
Male
Prostate Cancer
Trial Information
A Randomized Pilot Clinical Trial Of The Action Of Isoflavones And Lycopene In Localized Prostate Cancer: Administration Prior To Radical Prostatectomy
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.
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
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Occurrences of Treatment Effect on Biomarkers in Each Group
Outcome Description:
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
Outcome Time Frame:
4 years
Safety Issue:
No
Principal Investigator
Nagi B. Kumar, PhD, RD, FADA
Investigator Role:
Study Chair
Investigator Affiliation:
H. Lee Moffitt Cancer Center and Research Institute
Authority:
United States: Federal Government
Study ID:
MCC-13004
NCT ID:
NCT00042731
Start Date:
July 2002
Completion Date:
August 2006
Related Keywords:
- Prostate Cancer
- stage I prostate cancer
- stage IIB prostate cancer
- stage IIA prostate cancer
- Prostatic Neoplasms
Name | Location |
|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Tampa, Florida 33612 |
| CCOP - MeritCare Hospital | Fargo, North Dakota 58122 |
| CCOP - Western Regional, Arizona | Phoenix, Arizona 85006-2726 |
| CCOP - Scott and White Hospital | Temple, Texas 76508 |
| Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler | Savannah, Georgia 31405 |
