Clinical trial NCT00042731: Isoflavones & Lycopene in Localized Prostate Ca:Prior to Radical Prostatectomy
Official title: A Randomized Pilot Clinical Trial Of The Action Of Isoflavones And Lycopene In Localized Prostate Cancer: Administration Prior To Radical Prostatectomy
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2003-01-27
Enrollment: 79
Sex: MALE
Minimum age (years): 45
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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 groups.

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

Eligibility 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

Primary outcomes:
measure: Occurrences of Treatment Effect on Biomarkers in Each Group
timeFrame: 4 years
Secondary outcomes:
measure: Occurrences of Plasma Level Changes for Each Group
timeFrame: 4 years
measure: Occurrence of Tissue Level Increases
timeFrame: 4 years
measure: Occurrences of Disease Progression for Each Group
timeFrame: 4 years
measure: Occurrences of Hormonal Effect
timeFrame: 4 years
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: CCOP - Western Regional, Arizona
state: Arizona
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
city: Savannah
country: United States
facility: Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
state: Georgia
city: Fargo
country: United States
facility: CCOP - MeritCare Hospital
state: North Dakota
city: Temple
country: United States
facility: CCOP - Scott and White Hospital
state: Texas
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Nagi B. Kumar, PhD, RD, FADA
role: STUDY_CHAIR
References: