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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Lycopene
Multivitamin
Soy isoflavones
Sponsored by
H. Lee Moffitt Cancer Center and Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prostate Cancer focused on measuring stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

  • CCOP - Western Regional, Arizona
  • H. Lee Moffitt Cancer Center and Research Institute
  • Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
  • CCOP - MeritCare Hospital
  • CCOP - Scott and White Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Oral isoflavones with multivitamin

Oral lycopene with multivitamin

Multiple vitamin alone

Arm Description

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.

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.

Patients receive a multivitamin once daily. Treatment in all arms continues for 4-6 weeks, until prostatectomy.

Outcomes

Primary Outcome Measures

Occurrences of Treatment Effect on Biomarkers in Each Group
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
Plasma levels of isoflavones and lycopene as measured by plasma analysis at baseline and post-study intervention
Occurrence of Tissue Level Increases
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
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
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

Full Information

First Posted
August 5, 2002
Last Updated
September 21, 2012
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT00042731
Brief Title
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

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
July 2002 (undefined)
Primary Completion Date
August 2006 (Actual)
Study Completion Date
August 2006 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
stage I prostate cancer, stage IIB prostate cancer, stage IIA prostate cancer

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
79 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral isoflavones with multivitamin
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Oral lycopene with multivitamin
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Multiple vitamin alone
Arm Type
Active Comparator
Arm Description
Patients receive a multivitamin once daily. Treatment in all arms continues for 4-6 weeks, until prostatectomy.
Intervention Type
Dietary Supplement
Intervention Name(s)
Lycopene
Intervention Description
Daily administration as outlined in treatment arm(s)
Intervention Type
Dietary Supplement
Intervention Name(s)
Multivitamin
Intervention Description
Daily administration as outlined in treatment arm(s)
Intervention Type
Dietary Supplement
Intervention Name(s)
Soy isoflavones
Intervention Description
Daily administration as outlined in treatment arm(s)
Primary Outcome Measure Information:
Title
Occurrences of Treatment Effect on Biomarkers in Each Group
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
Time Frame
4 years
Secondary Outcome Measure Information:
Title
Occurrences of Plasma Level Changes for Each Group
Description
Plasma levels of isoflavones and lycopene as measured by plasma analysis at baseline and post-study intervention
Time Frame
4 years
Title
Occurrence of Tissue Level Increases
Description
Correlation of plasma and tissue levels of isoflavones and lycopene as measured by plasma and tissue analysis at baseline and post-study intervention
Time Frame
4 years
Title
Occurrences of Disease Progression for Each Group
Description
Effect of isoflavones and lycopene on markers of disease progression as measured by prostate-specific antigen (PSA) levels at baseline and post-study intervention
Time Frame
4 years
Title
Occurrences of Hormonal Effect
Description
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
Time Frame
4 years

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nagi B. Kumar, PhD, RD, FADA
Organizational Affiliation
H. Lee Moffitt Cancer Center and Research Institute
Official's Role
Study Chair
Facility Information:
Facility Name
CCOP - Western Regional, Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006-2726
Country
United States
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612-9497
Country
United States
Facility Name
Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31405-6015
Country
United States
Facility Name
CCOP - MeritCare Hospital
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58122
Country
United States
Facility Name
CCOP - Scott and White Hospital
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States

12. IPD Sharing Statement

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

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