Clinical trial · Interventional
Lycopene in Treating Patients Undergoing Radical Prostatectomy for Prostate Cancer
Phase II Placebo Controlled Trial of Preoperative Lycopene Supplementation in Prostate Cancer Patients
NCT00450749CI-TRIAL-00042399completedPhase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenocarcinoma of the Prostate | Prostate Adenocarcinoma | ALIAS | 0.90 |
| Stage III Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage II Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
| Stage I Prostate Cancer | Malignant Prostate Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| laboratory biomarker analysis | Other | — | UNRESOLVED |
| lycopene | Drug | — | UNRESOLVED |
| placebo | Other | — | UNRESOLVED |
| therapeutic conventional surgery | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- PLACEBO_COMPARATOR
- label
- Arm I (placebo)
- description
- Patients receive placebo PO QD for 4-7 weeks, and then undergo radical prostatectomy.
- interventionNames
- Other: placebo
- Procedure: therapeutic conventional surgery
- Other: laboratory biomarker analysis
- type
- EXPERIMENTAL
- label
- Arm II (low-dose lycopene)
- description
- Patients receive low-dose lycopene PO QD for 4-7 weeks, and then undergo radical prostatectomy.
- interventionNames
- Procedure: therapeutic conventional surgery
- Other: laboratory biomarker analysis
- Drug: lycopene
- type
- EXPERIMENTAL
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available
No reference posted for this study.