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

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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Dietary supplement: Multivitamin; Dietary supplement: Soy isoflavones; Dietary supplement: Lycopene

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.

• Study Type: Interventional
• Enrollment (Actual): 79
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006-2726
      • CCOP - Western Regional, Arizona
  • Florida
    • Tampa, Florida, United States, 33612-9497
      • H. Lee Moffitt Cancer Center and Research Institute
  • Georgia
    • Savannah, Georgia, United States, 31405-6015
      • Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler
  • North Dakota
    • Fargo, North Dakota, United States, 58122
      • CCOP - MeritCare Hospital
  • Texas
    • Temple, Texas, United States, 76508
      • CCOP - Scott and White Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 43 years to 78 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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: Multivitamin; Daily administration as outlined in treatment arm(s); Dietary supplement: Lycopene; 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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	4 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	4 years
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	4 years
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	4 years
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	4 years

Collaborators and Investigators

• Sponsor: H. Lee Moffitt Cancer Center and Research Institute
• Collaborators: National Cancer Institute (NCI)
• Investigators: Study Chair: Nagi B. Kumar, PhD, RD, FADA, H. Lee Moffitt Cancer Center and Research Institute

Study record dates

Study Major Dates

• Study Start: July 1, 2002
• Primary Completion (Actual): August 1, 2006
• Study Completion (Actual): August 1, 2006

Study Registration Dates

• First Submitted: August 5, 2002
• First Submitted That Met QC Criteria: January 26, 2003
• First Posted (Estimate): January 27, 2003

Study Record Updates

• Last Update Posted (Estimate): September 24, 2012
• Last Update Submitted That Met QC Criteria: September 21, 2012
• Last Verified: September 1, 2012

More Information

Terms related to this study

• Keywords: stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Antineoplastic Agents; Protective Agents; Antioxidants; Anticarcinogenic Agents; Radiation-Protective Agents; Lycopene
• Other Study ID Numbers: MCC-13004; NCI-3811 (Other Identifier: NCI); NCI-P02-0216 (Other Identifier: NCI); 0105 (CCOP)