Lycopene in Treating Patients Undergoing Radical Prostatectomy for Prostate Cancer
This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00450749
First received: March 20, 2007
Last updated: April 30, 2013
Last verified: April 2013
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Purpose
This randomized phase II trial studies how well different doses of lycopene work in treating patients undergoing radical prostatectomy for prostate cancer. The use of lycopene, a substance found in tomatoes, may keep prostate cancer from growing or coming back after surgery.
| Condition | Intervention | Phase |
|---|---|---|
|
Adenocarcinoma of the Prostate Stage I Prostate Cancer Stage II Prostate Cancer Stage III Prostate Cancer |
Other: placebo Procedure: therapeutic conventional surgery Other: laboratory biomarker analysis Drug: lycopene |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment |
| Official Title: | Phase II Placebo Controlled Trial of Preoperative Lycopene Supplementation in Prostate Cancer Patients |
Resource links provided by NLM:
Further study details as provided by National Cancer Institute (NCI):
Primary Outcome Measures:
- Concentration of Lycopene in Prostatic Surgical Tissue [ Time Frame: At 4-7 weeks ] [ Designated as safety issue: No ]Total tissue lycopene concentrations in radical prostatectomy specimens in participants receiving 6 weeks (± 1 week) of preoperative supplementation with 60 mg/day lycopene, 30 mg/day lycopene, or placebo. Concentration of lycopene in prostatic surgical tissue calculated using the high-performance liquid chromatography (HPLC) method.
- Change in Serum Lycopene Concentration [ Time Frame: Baseline and at 4-7 weeks ] [ Designated as safety issue: No ]The differences in the mean of the 6 week (± 1 week) serum lycopene concentrations after adjusting for baseline serum lycopene concentrations calculated between the three arms, together with 95% confidence intervals.
Secondary Outcome Measures:
- Ratio of Testosterone (T) to Dihydrotestosterone (DHT) in Serum [ Time Frame: Baseline and at 4-7 weeks ] [ Designated as safety issue: No ]
- Ratio of T:DHT in Prostatic Surgical Tissue [ Time Frame: At 4-7 weeks ] [ Designated as safety issue: No ]
- Serum Concentrations of Total Prostate-specific Antigen (PSA), Free PSA, and Human Kallikrein 2 [ Time Frame: Baseline and at 4-7 weeks ] [ Designated as safety issue: No ]
- Growth Potential Assessed by the Ratio of Proliferation (Ki-67):Apoptosis (TUNEL) in Prostatic Surgical Tissue [ Time Frame: At 4-7 weeks ] [ Designated as safety issue: No ]
- Serum Concentrations of Insulin-like Growth Factor (IGF)-1 and IGF Binding Protein-3 [ Time Frame: At baseline and at 4-7 weeks ] [ Designated as safety issue: No ]
- Lymphocyte Oxidative DNA Damage Capacity as Measured by Comet Assay [ Time Frame: At baseline and at 4-7 weeks ] [ Designated as safety issue: No ]
- Expression of GST-pi in Prostatic Surgical Tissue [ Time Frame: At 4-7 weeks ] [ Designated as safety issue: No ]
- Histological Characteristics of Prostatic Surgical Tissue [ Time Frame: At 4-7 weeks ] [ Designated as safety issue: No ]
- Modulation of Expression of Androgen-related Genes as Measured by Microarray in Prostatic Surgical Tissue [ Time Frame: At 4-7 weeks ] [ Designated as safety issue: No ]
| Enrollment: | 11 |
| Study Start Date: | February 2008 |
| Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: Arm I (placebo)
Patients receive placebo PO QD for 4-7 weeks, and then undergo radical prostatectomy.
|
Other: placebo
Given PO
Other Name: PLCB
Procedure: therapeutic conventional surgery
Undergo radical prostatectomy
Other: laboratory biomarker analysis
Correlative studies
|
|
Experimental: Arm II (low-dose lycopene)
Patients receive low-dose lycopene PO QD for 4-7 weeks, and then undergo radical prostatectomy.
|
Procedure: therapeutic conventional surgery
Undergo radical prostatectomy
Other: laboratory biomarker analysis
Correlative studies
Drug: lycopene
Given PO
Other Names:
|
|
Experimental: Arm III (high-dose lycopene)
Patients receive high-dose lycopene PO QD for 4-7 weeks, and then undergo radical prostatectomy.
|
Procedure: therapeutic conventional surgery
Undergo radical prostatectomy
Other: laboratory biomarker analysis
Correlative studies
Drug: lycopene
Given PO
Other Names:
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
Criteria:
- Creatinine normal
- Biopsy-confirmed adenocarcinoma of the prostate
- Localized disease
- Planned radical prostatectomy
- ECOG performance status (PS) 0-2 OR Karnofsky PS 60-100%
- WBC >= 3,000/mm^3
- Platelet count >= 100,000/mm^3
- Bilirubin normal
- AST and ALT =< 2.5 times upper limit of normal
- Fertile patients must use effective barrier contraception
- No other invasive cancer (except nonmelanoma skin cancer) within the past 2 years
- Patients who received curative treatment and have shown no evidence of recurrence within the past 2 years are eligible
- No history of allergic reactions attributed to compounds of similar chemical or biological composition to lycopene (e.g., other carotenoids, including lutein and beta-carotene)
- More than 30 days since prior regular (> once weekly) lycopene supplementation (>= 15 mg/day) and meets the following criteria: no more than 2 servings of tomato sauce, juice, or soup per week; no more than 4 servings of grapefruit, raw tomato, or watermelon per week
- Must not consume 1 serving of tomato sauce, juice, or soup per week AND more than 2 servings of grapefruit, raw tomato, or watermelon per week
- More than 30 days since prior and no concurrent investigational medication
- No concurrent chemotherapy, radiotherapy, hormonal therapy, or immunotherapy
- No history of allergy to foods containing lycopene (e.g., tomatoes or tomato products, watermelon, guava, and pink grapefruit)
- No concurrent uncontrolled illness including, but not limited to, any of the following: ongoing or active infection; symptomatic congestive heart failure; unstable angina pectoris; cardiac arrhythmia; psychiatric illness/social situations that would limit compliance with study requirements
- No prior therapy for prostate cancer, including radiotherapy to the prostate or pelvis, androgen ablation, or antiandrogen systemic therapy
- No other concurrent lycopene (>= 15 mg/day)
Contacts and Locations More Information
No publications provided
| Responsible Party: | National Cancer Institute (NCI) |
| ClinicalTrials.gov Identifier: | NCT00450749 History of Changes |
| Other Study ID Numbers: | NCI-2009-00857, 2006-0388, MSKCC-06118, MDA-CC-2006-0388, CDR0000532938, CDR0000653464, 06-118, N01CN35159 |
| Study First Received: | March 20, 2007 |
| Results First Received: | March 30, 2012 |
| Last Updated: | April 30, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Adenocarcinoma Adenocarcinoma, Mucinous Prostatic Neoplasms Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Cystic, Mucinous, and Serous Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site 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