Clinical trial · Interventional
The Effects of Lycopene on High Risk Prostatic Tissue
R01 CA90759: The Effects of Lycopene on High Risk Prostatic Tissue
NCT01443026CI-TRIAL-00041765completedPhase 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)
The purpose of this research study is to compare the effects of a lycopene supplement made from tomatoes to a placebo (a capsule with no active ingredients) in men who have abnormal cells in the prostate, but have not yet had cancer detected. This study will allow us to see if taking lycopene for six months leads to favorable changes in abnormal prostate tissue and in chemicals measured in the blood that go along with a higher risk of developing cancer.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Intraepithelial Prostatic Neoplasia | Prostatic Intraepithelial Neoplasia | ALIAS | 0.90 |
| Prostatic Neoplasms | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lycopene 30mg | Drug | — | UNRESOLVED |
| Placebo | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Lycopene
- description
- Lycopene 30 mg/day
- interventionNames
- Drug: Lycopene 30mg
- type
- PLACEBO_COMPARATOR
- label
- Placebo
- description
- Placebo
- interventionNames
- Drug: Placebo
Primary outcomes (2)
- measure
- Tissue Biomarkers
- timeFrame
- baseline and 6 months
- description
- We will use conventional immunohistochemistry and computer-based image analysis to test the hypothesis that the lycopene supplements alter the expression of proteins marking the status of proliferation, differentiation, cell regulation and apoptosis in high-risk tissue.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * Male * Have a history of prostate biopsy indicating HGPIN without cancer within 2 years prior to registration. At least 4 weeks must have elapsed between the last biopsy and the biopsy used for baseline data. * Have an AUA symptom score \<=25 at time of registration. * Refrain from taking lycopene, selenium, vitamin E, or other antioxidant supplements within 1 month of randomization. Participants must agree to refrain from taking non-study dietary supplements while on study * Refrain from taking exogenous hormones, drugs affecting hormone metabolism, or specified non-prescription substances (e.g. saw palmetto, PC-Spes) taken to affect the prostate within 1 month of registration. Patients must also agree to refrain from taking the non-prescription substances while on study * Be willing to limit intake of lycopene-containing foods while on study * Have no prior cancer (except basal cell or squamous cell skin cancer) or complete remission for at least 5 years * Be ambulatory, capable of self-care and able to carry out light or sedentary work * Have a dietary fat intake of 23-48% of calories * Participant's physician recommends repeat biopsy 4-6 months after randomization Exclusion Criteria: * No repeat biopsy planned * Not willing to change diet * Have a diagnosis of prostate cancer
References
Publications (7)
- BACKGROUNDClinton SK, Emenhiser C, Schwartz SJ, Bostwick DG, Williams AW, Moore BJ, Erdman JW Jr. cis-trans lycopene isomers, carotenoids, and retinol in the human prostate. Cancer Epidemiol Biomarkers Prev. 1996 Oct;5(10):823-33. PMID 8896894
- BACKGROUNDPastori M, Pfander H, Boscoboinik D, Azzi A. Lycopene in association with alpha-tocopherol inhibits at physiological concentrations proliferation of prostate carcinoma cells. Biochem Biophys Res Commun. 1998 Sep 29;250(3):582-5. doi: 10.1006/bbrc.1998.9351. PMID 9784387
- BACKGROUNDGiovannucci E. Tomatoes, tomato-based products, lycopene, and cancer: review of the epidemiologic literature. J Natl Cancer Inst. 1999 Feb 17;91(4):317-31. doi: 10.1093/jnci/91.4.317. PMID 10050865
- BACKGROUNDJain MG, Hislop GT, Howe GR, Ghadirian P. Plant foods, antioxidants, and prostate cancer risk: findings from case-control studies in Canada. Nutr Cancer. 1999;34(2):173-84. doi: 10.1207/S15327914NC3402_8. PMID 10578485
- BACKGROUNDGiovannucci E, Ascherio A, Rimm EB, Stampfer MJ, Colditz GA, Willett WC. Intake of carotenoids and retinol in relation to risk of prostate cancer. J Natl Cancer Inst. 1995 Dec 6;87(23):1767-76. doi: 10.1093/jnci/87.23.1767. PMID 7473833
- BACKGROUNDBostwick DG, Shan A, Qian J, Darson M, Maihle NJ, Jenkins RB, Cheng L. Independent origin of multiple foci of prostatic intraepithelial neoplasia: comparison with matched foci of prostate carcinoma. Cancer. 1998 Nov 1;83(9):1995-2002. doi: 10.1002/(sici)1097-0142(19981101)83:93.0.co;2-2. PMID 9806659
- BACKGROUNDKley HK. [Therapy of Cushing's syndrome. Critical evaluation of therapeutic measures]. Hippokrates. 1978 Feb;49(1):97-100. No abstract available. German. PMID 632120