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

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT00042731
First received: August 5, 2002
Last updated: September 21, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Prostate Cancer
Dietary Supplement: Lycopene
Dietary Supplement: Multivitamin
Dietary Supplement: Soy isoflavones

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: A Randomized Pilot Clinical Trial Of The Action Of Isoflavones And Lycopene In Localized Prostate Cancer: Administration Prior To Radical Prostatectomy

Resource links provided by NLM:


Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:

Primary Outcome Measures:
  • Occurrences of Treatment Effect on Biomarkers in Each Group [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Occurrences of Plasma Level Changes for Each Group [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Plasma levels of isoflavones and lycopene as measured by plasma analysis at baseline and post-study intervention

  • Occurrence of Tissue Level Increases [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Correlation of plasma and tissue levels of isoflavones and lycopene as measured by plasma and tissue analysis at baseline and post-study intervention

  • Occurrences of Disease Progression for Each Group [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    Effect of isoflavones and lycopene on markers of disease progression as measured by prostate-specific antigen (PSA) levels at baseline and post-study intervention

  • Occurrences of Hormonal Effect [ Time Frame: 4 years ] [ Designated as safety issue: No ]
    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


Enrollment: 79
Study Start Date: July 2002
Study Completion Date: August 2006
Primary Completion Date: August 2006 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Oral isoflavones with multivitamin
Cohorts I - III: Patients receive 1 of 3 doses of oral isoflavones twice daily and a multivitamin once daily. Treatment in all arms continues for 4-6 weeks, until prostatectomy.
Dietary Supplement: Multivitamin
Daily administration as outlined in treatment arm(s)
Dietary Supplement: Soy isoflavones
Daily administration as outlined in treatment arm(s)
Active Comparator: Oral lycopene with multivitamin
Cohorts IV-VI: Patients receive 1 of 3 doses of oral lycopene twice daily and a multivitamin once daily. Treatment in all arms continues for 4-6 weeks, until prostatectomy.
Dietary Supplement: Lycopene
Daily administration as outlined in treatment arm(s)
Dietary Supplement: Multivitamin
Daily administration as outlined in treatment arm(s)
Active Comparator: Multiple vitamin alone
Patients receive a multivitamin once daily. Treatment in all arms continues for 4-6 weeks, until prostatectomy.
Dietary Supplement: Multivitamin
Daily administration as outlined in treatment arm(s)

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

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00042731

Locations
United States, Arizona
CCOP - Western Regional, Arizona
Phoenix, Arizona, United States, 85006-2726
United States, Florida
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612-9497
United States, Georgia
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
Savannah, Georgia, United States, 31405-6015
United States, North Dakota
CCOP - MeritCare Hospital
Fargo, North Dakota, United States, 58122
United States, Texas
CCOP - Scott and White Hospital
Temple, Texas, United States, 76508
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Investigators
Study Chair: Nagi B. Kumar, PhD, RD, FADA H. Lee Moffitt Cancer Center and Research Institute
  More Information

Additional Information:
No publications provided

Responsible Party: H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier: NCT00042731     History of Changes
Other Study ID Numbers: MCC-13004, NCI-3811, NCI-P02-0216, 0105
Study First Received: August 5, 2002
Last Updated: September 21, 2012
Health Authority: United States: Federal Government

Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
stage I prostate cancer
stage IIB prostate cancer
stage IIA prostate cancer

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Diseases, Male
Genital Neoplasms, Male
Neoplasms
Neoplasms by Site
Prostatic Diseases
Urogenital Neoplasms
Lycopene
Anticarcinogenic Agents
Antineoplastic Agents
Antioxidants
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Radiation-Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on November 20, 2014