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

NCT00042731 | Completed

• 4 other identifiers: MCC-13004NCI-3811NCI-P02-02160105
• Study Type: interventional
• Target: 79
• Locations: 1 country
• Sites: 5

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.

Conditions

Prostate Cancer

Keywords

stage I prostate cancer; stage IIB prostate cancer; stage IIA prostate cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Occurrences of Plasma Level Changes for Each Group

  4 years

• Occurrence of Tissue Level Increases

  4 years

• Occurrences of Disease Progression for Each Group

  4 years

• Occurrences of Hormonal Effect

  4 years

Study Arms (3)

Oral isoflavones with multivitamin

ACTIVE COMPARATOR

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; Dietary Supplement: Soy isoflavones

Oral lycopene with multivitamin

ACTIVE COMPARATOR

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; Dietary Supplement: Multivitamin

Multiple vitamin alone

ACTIVE COMPARATOR

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

Dietary Supplement: Multivitamin

Interventions

Lycopene DIETARY_SUPPLEMENT

Daily administration as outlined in treatment arm(s)

Oral lycopene with multivitamin

Multivitamin DIETARY_SUPPLEMENT

Daily administration as outlined in treatment arm(s)

Multiple vitamin alone; Oral isoflavones with multivitamin; Oral lycopene with multivitamin

Soy isoflavones DIETARY_SUPPLEMENT

Daily administration as outlined in treatment arm(s)

Oral isoflavones with multivitamin

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• National Cancer Institute (NCI): collaborator

Study Sites (5)

CCOP - Western Regional, Arizona

Phoenix, Arizona, 85006-2726, United States

Location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612-9497, United States

Location

Nancy N. and J. C. Lewis Cancer and Research Pavilion at St. Joseph's/Candler

Savannah, Georgia, 31405-6015, United States

Location

CCOP - MeritCare Hospital

Fargo, North Dakota, 58122, United States

Location

CCOP - Scott and White Hospital

Temple, Texas, 76508, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Lycopene; Geritol; Soybean Proteins

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Carotenoids; Polyenes; Alkenes; Hydrocarbons, Acyclic; Hydrocarbons; Organic Chemicals; Cyclohexenes; Cyclohexanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Terpenes; Pigments, Biological; Biological Factors; Plant Proteins; Proteins; Amino Acids, Peptides, and Proteins; Plant Proteins, Dietary; Dietary Proteins; Food; Diet, Food, and Nutrition; Physiological Phenomena; Soy Foods; Vegetable Products; Vegetables; Food and Beverages

Study Officials

• Nagi B. Kumar, PhD, RD, FADA

  H. Lee Moffitt Cancer Center and Research Institute

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 5, 2002
• First Posted: January 27, 2003
• Study Start: July 1, 2002
• Primary Completion: August 1, 2006
• Study Completion: August 1, 2006
• Last Updated: September 24, 2012

Record last verified: 2012-09

Locations

US (5)