Phase 2
Completed N=10
Lycopene in Treating Patients Undergoing Radical Prostatectomy for Prostate Cancer
Prostate Cancer · Stage I Prostate Cancer · Stage II Prostate Cancer · Stage III Prostate Cancer
Source: ClinicalTrials.gov NCT00450749 ↗
Enrolled (actual)
10
Serious AEs
0.0%
Results posted
Jul 2012
Primary outcomePrimary: Concentration of Lycopene in Prostatic Surgical Tissue — 0.663; 0.378; 0.723; 0.165 ug/dL
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Concentration of Lycopene in Prostatic Surgical Tissue |
0.663; 0.378; 0.723; 0.165; 0.749; NA | — |
| PRIMARY Serum Levels (ug/dL) of Total Lycopene at Baseline and During Treatment by Group |
25.3; 32.0; 22.7; 98.7; 40.4; 61.5 | — |
| SECONDARY Ratio of T:DHT in Prostatic Surgical Tissue |
— | — |
| SECONDARY Serum Concentrations of Total Prostate-specific Antigen (PSA), Free PSA, and Human Kallikrein 2 |
— | — |
| SECONDARY Growth Potential Assessed by the Ratio of Proliferation (Ki-67):Apoptosis (TUNEL) in Prostatic Surgical Tissue |
— | — |
| SECONDARY Serum Concentrations of Insulin-like Growth Factor (IGF)-1 and IGF Binding Protein-3 |
— | — |
| SECONDARY Lymphocyte Oxidative DNA Damage Capacity as Measured by Comet Assay |
— | — |
| SECONDARY Expression of GST-pi in Prostatic Surgical Tissue |
— | — |
| SECONDARY Histological Characteristics of Prostatic Surgical Tissue |
— | — |
| SECONDARY Modulation of Expression of Androgen-related Genes as Measured by Microarray in Prostatic Surgical Tissue |
— | — |
| SECONDARY Ratio of Testosterone (T) to Dihydrotestosterone (DHT) in Serum |
— | — |
Eligibility 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 = 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)
Data sourced from ClinicalTrials.gov (NCT00450749). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.