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


N/A
45 Years
80 Years
Not Enrolling
Male
Prostate Cancer

Thank you

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 InstituteTampa, Florida  33612
CCOP - MeritCare HospitalFargo, North Dakota  58122
CCOP - Western Regional, ArizonaPhoenix, Arizona  85006-2726
CCOP - Scott and White HospitalTemple, Texas  76508
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/CandlerSavannah, Georgia  31405