Isoflavones & Lycopene in Localized Prostate Ca:Prior to Radical Prostatectomy
This study has been completed.
Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
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
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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
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 Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Genital Diseases, Male Prostatic Diseases Lycopene Antioxidants |
Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Protective Agents Physiological Effects of Drugs Radiation-Protective Agents Anticarcinogenic Agents Antineoplastic Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013