Lycopene (Prostate)

BACKGROUND: Prostate cancer is a major malignancy, affecting men, worldwide. The protective effect of dietary or supplemental lycopene on prostate cancer has been reported in several studies; however, the findings are equivocal. OBJECTIVE: The aim of this study was to evaluate the effects of supplemental lycopene on PSA level, by conducting a systematic review and meta-analysis of randomized controlled trials. METHODS: We searched online databases, including PubMed, Scopus, and Web of Science, up to 9 Jun 2020, to obtain relevant publications. The publication search was not limited by language or date. RESULTS: A total of 1036 records were identified in the systematic search; from these, 9 were included in the systematic review and 6 in meta-analysis. The pooled analysis of the 6 studies showed no significant differences in PSA levels in subjects treated with lycopene or tomato extract containing lycopene (WMD= -0.12 ng/ml; 95% CI: -0.62, 0.38 ng/ml; P = 0.64) compared to the control. CONCLUSION: Overall, tomato extracts or lycopene treatment yielded no significant effect on PSA level compared to the control. However, more consistent clinical trials, with larger sample sizes, are required to better discern the actual effect of tomato extract or lycopene on PSA level.

Comment in Nutr Cancer. 2022;74(3):806-807. doi: 10.1080/01635581.2021.2022724. Several randomized controlled trials (RCTs) have investigated the effect of lycopene supplementation on serum levels of prostate-specific antigen (PSA) in patients with prostate cancer. However, results have been inconclusive. We systematically searched PubMed, Embase, and Scopus up to January 2020 to find RCTs investigating the effect of lycopene supplementation on serum levels of PSA in patients with non-metastatic prostate cancer. Using a random-effects model, the reported risk estimates were pooled. A total of six trials were included in the final analysis. we found no significant effect of lycopene on circulating PSA (WMD: -0.60, 95% CI: -2.01, 0.81 µg/L). However, we observed a significant reducing effect when the analysis was confined to studies that included patients with higher baseline levels of PSA (≥6.5 µg/L) (WMD: -3.74 µg/L, 95% CI: -5.15, -2.32, P < 0.001). Subgroup analysis based on the duration of intervention did not result in any significant effect. Non-linear dose-response analysis did not show any significant effects of lycopene dosage (Pnon-linearity = 0.50) and duration of the intervention (Pnon-linearity = 0.63) on serum levels of PSA. Although lycopene supplementation did not produce any reduction in PSA levels overall, a significant reducing effect was observed in patients with higher levels of baseline PSA. Due to the heterogeneity of our results, further high-quality clinical trials with long-term duration are required to determine the efficacy of lycopene in patients with non-metastatic prostate cancer.

We reviewed 37 prospective cohort and four intervention studies on potential dietary risk factors for prostate cancer, published between 1966 and September 2003. Some studies were limited by small size, crude measurement of dietary exposure and limited control for confounders. Intervention and prospective cohort studies support a protective role against prostate cancer for selenium, and possibly for vitamin E, pulses and tomatoes/lycopene. Overall consumption of meat, eggs, vegetables, fruit, coffee, tea, carotenoids and vitamins A, C and D was not consistently related to prostate cancer risk. Intervention studies also indicate that supplementation with beta-carotene does not lower prostate cancer risk, except possibly in men with low beta-carotene status at baseline. For specific types of meat, alcoholic drinks, dairy products, fat and anthropometric measures, most cohort studies suggest either an increased risk or no relation with prostate cancer. For calcium, two cohort studies suggest an increased risk at very high calcium intakes (>2000 mg/day). In conclusion, prospective studies are consistent with a protective role for selenium, and possibly vitamin E, pulses and tomatoes/lycopene, in the aetiology of prostate cancer. Studies are inconclusive on the role of meat, dairy products, fat, vegetables, fruits, alcohol and anthropometric measures, whereas a very high calcium intake appears to be positively associated with prostate cancer risk.

Although much has been written, little is known about the causes of prostate cancer. Variations between populations in the incidence of invasive cancers, together with changes in the incidence of invasive cancers in migrants, have pointed to environmental (lifestyle) factors that might be amenable to intervention. Conversely, there is a lack of international variation in the prevalence of microscopic tumours, so the essential question is: what causes only some of the common microscopic tumours to become aggressive? Dietary factors hold the most promise in this regard and have been the subject of recent reviews. The strongest and most consistent effects are positive associations with animal products such as red meats, eggs and dairy foods, and possibly by implication, fat. Evidence of a protective effect of fruit and vegetables is weak and inconsistent, as is the relationship with vitamin A and carotenoids, such as beta-carotene. There are some interesting leads. Lycopene, the carotenoid found in tomatoes, has been reported to be protective; alpha-tocopherol supplementation has shown a protective effect in one intervention study; and vitamin D has been shown to be protective in a prospective study. Interest is also growing in phytoestrogens and the extent to which dietary manipulation with these and other phytochemicals might influence prostate cancer by modifying male sex hormone levels or actions. There is limited evidence of associations with obesity. It is not known whether these are related to a particular dietary pattern or to possible physiological effects on the male's hormonal milieu. Associations with lean body mass are likely to be related to the action of androgens during growth and development. Dietary and nutritional effects on prostate cancer do not appear to be strong, but they may be subtle and attenuated by measurement error. To explore these aspects further will require large prospective studies that include improved (repeated) dietary measurements and also blood sampling, so that genetic polymorphisms can be adequately investigated. Such studies are underway.

BACKGROUND: Intake of lycopene has been proposed as a protective dietary factor against prostate cancer development. Cardiovascular disease and prostate cancer share risk factors, which may modulate the effect of lycopene in high-risk individuals. This study aimed to examine the association between lycopene intake and prostate cancer risk in a Mediterranean population at high cardiovascular risk. METHODS: A prospective cohort analysis was conducted among 2970 men aged 55-80 years at high cardiovascular risk from the PREDIMED trial, a multicenter study in Spain. Lycopene intake was assessed using repeated food frequency questionnaires. Prostate cancer cases were identified through medical records and death certificates. Cox proportional hazard models were used to estimate hazard ratios (HR) and 95% confidence intervals (CI) across lycopene intake quartiles. RESULTS: Over a mean follow-up of 5.8 years, 104 prostate cancer cases were identified. Participants in the highest quartile of lycopene intake had a significantly lower risk of prostate cancer than those in the lowest quartile (HR: 0.46; 95% CI: 0.23-0.95; p-trend = 0.035). A nonlinear dose-response relationship was observed, with a significant inverse association emerging at intakes above 4.9 mg/day (HR: 0.36; 95% CI: 0.13-0.98). CONCLUSIONS: Higher lycopene intake suggested a protective association with a lower incidence of prostate cancer in men at high cardiovascular risk. These findings support the role of lycopene-rich diets in prostate cancer prevention, which may be particularly relevant for high cardiovascular risk populations. TRIAL REGISTRATION: ISRCTN registry: ISRCTN35739639 (PREDIMED trial). © 2025. The Author(s).

Enzalutamide is an effective drug for the treatment of castration-resistant prostate cancer (CRPC), but acquired enzalutamide resistance is usually unavoidable within the short term in many patients. Lycopene, a safe and effective phytochemical, has been documented to have anticancer activity in a variety of tumors, especially for prostate cancer (PCa). The aim of this study was to provide data support for the combination of lycopene and enzalutamide in the treatment of CRPC. To this end, tissues from patients with primary prostate cancer (PPC) and CRPC were examined by immunohistochemical analysis and found that p-AKT and p-EZH2 were overexpressed in CRPC. Furthermore, Kaplan-Meier survival analysis showed that the high expression of p-AKT and p-EZH2 may be related to the poor prognosis of patients. In addition, the expression of p-AKT, p-EZH2 and androgen receptor (AR) were significantly down-regulated in 22RV1 and C4-2B cells and the proliferation and invasion of CRPC cells were inhibited after treatment with lycopene, while SC79 (an AKT agonist) markedly rescue this effect. Of note, a combination of lycopene and enzalutamide significantly inhibited the proliferation and invasion of CRPC cells in vitro, as well as tumor growth and bone metastasis in vivo. These results suggest that the enhanced antitumor effects of enzalutamide by lycopene may be related to the reduction of AR protein levels through lycopene-mediated inhibition of AKT/EZH2 pathway, which may provide a new approach to improve the efficacy of enzalutamide in CRPC.

Epidemiological studies have consistently shown that regular consumption of fruits and vegetables is strongly associated with reduced risk of developing chronic diseases, such as cancer. It is now accepted that the actions of any specific phytonutrient alone do not explain the observed health benefits of diets rich in fruits and vegetables as nutrients that were taken alone in clinical trials did not show consistent preventive effects. The considerable cost and complexity of such clinical trials requires prudent selection of combinations of ingredients rather than single compounds. Indeed, synergistic inhibition of prostate and mammary cancer cell growth was evident when using combinations of low concentrations of various carotenoids or carotenoids with retinoic acid and the active metabolite of vitamin-D. In this study we aimed to develop simple and sensitive in vitro methods which provide information on potent combinations suitable for inclusion in clinical studies for cancer prevention. We, thus, used reporter gene assays of the transcriptional activity of the androgen receptor in hormone-dependent prostate cancer cells and of the electrophile/antioxidant response element (EpRE/ARE) transcription system. We found that combinations of several carotenoids (e.g., lycopene, phytoene and phytofluene), or carotenoids and polyphenols (e.g., carnosic acid and curcumin) and/or other compounds (e.g., vitamin E) synergistically inhibit the androgen receptor activity and activate the EpRE/ARE system. The activation of EpRE/ARE was up to four fold higher than the sum of the activities of the single ingredients, a robust hallmark of synergy. Such combinations can further be tested in the more complex in vivo models and human studies.

In our previous study, we demonstrated that lycopene can inhibit the proliferation of androgen-dependent prostate LNCaP cancer cells through the activation of the peroxisome proliferator-activated receptor gamma (PPARγ)-liver X receptor alpha (LXRα)-ATP-binding cassette transporter 1 (ABCA1) pathway. However, it is still unclear whether lycopene possesses similar effects in androgen-independent prostate cancer cells DU145 and PC-3. As lycopene inhibited the proliferation of both cell types to a similar extent, we chose DU145 cells for most of the subsequent studies. We show that lycopene significantly increased protein and mRNA expression of PPARγ, LXRα and ABCA1 and cholesterol efflux (i.e., decreased cellular cholesterol and increased cholesterol in culture medium). Lycopene (10 μM) in the presence of a specific antagonist of PPARγ (GW9662) or of LXRα (GGPP) restored the proliferation of DU145 cells and significantly suppressed lycopene-induced protein and mRNA expression of PPARγ and LXRα and cholesterol efflux. Liver X receptor α knockdown by siRNA against LXRα significantly promoted the proliferation of DU145 cells, whereas si-LXRα knockdown followed by incubation with lycopene (10 μM) restored the proliferation to the control level. Furthermore, lycopene in combination with the LXRα agonist T0901317 exhibited synergistic effects on cell proliferation and protein expression of PPARγ, LXRα and ABCA1. These results demonstrate that lycopene can inhibit DU145 cell proliferation via PPARγ-LXRα-ABCA1 pathway and that lycopene and T0901317 exhibit synergistic effects. Crown Copyright © 2012. Published by Elsevier Inc. All rights reserved.

Traditionally, long-term antibiotic therapy has been the gold standard treatment for chronic bacterial prostatitis (CBP). However, the treatment outcome is not ideal and long-term administration of antibiotics can result in adverse effects and bacterial resistance. For these reasons, both patients and physicians are dissatisfied with the management of this disease and there is interest in phytotherapy and other alternative therapies. Lycopene, an extract of tomatoes, has been reported to have an anti-inflammatory effect via an antioxidative function. To evaluate the therapeutic effect of lycopene on CBP, we developed a CBP rat model treated with ciprofloxacin or lycopene, or both. After 2 weeks of treatment, results of microbiological cultures of the prostate and urine as well as histological findings of the prostate were analysed. The ciprofloxacin group and the lycopene/ciprofloxacin group showed a statistically significant decrease in bacterial growth and improvement in prostatic inflammation compared with the control group. The lycopene/ciprofloxacin group also showed a statistically significant decrease in bacterial growth and improvement in prostatic inflammation compared with the ciprofloxacin group. These results suggest that lycopene may have an additional (synergistic) effect with ciprofloxacin in the treatment of CBP.

154. Clin J Oncol Nurs. 2005 Apr;9(2):245-6. doi: 10.1188/05.CJON.245-246. Complementary and alternative medicine patients are talking about: lycopene. Lee CO(1). Author information: (1)Office of Cancer Complementary and Alternative Medicine at the National Cancer Institute in Bethesda, MD, USA. [email protected] DOI: 10.1188/05.CJON.245-246 PMID: 15853167 [Indexed for MEDLINE]

155. Am J Health Syst Pharm. 2004 Aug 1;61(15):1562-6. doi: 10.1093/ajhp/61.15.1562. Lycopene for prevention and treatment of prostate cancer. Everson KM(1), McQueen CE. Author information: (1)Drug Information Center, University of Missouri-Kansas City, 64108, USA. DOI: 10.1093/ajhp/61.15.1562 PMID: 15372829 [Indexed for MEDLINE]

156. J Natl Cancer Inst. 2004 Apr 7;96(7):554; author reply 554-5. doi: 10.1093/jnci/djh089. Re: Prostate carcinogenesis in N-methyl-N-nitrosourea (NMU)-testosterone-treated rats fed tomato powder, lycopene, or energy-restricted diets. Limpens J, van Weerden WM, Krämer K, Pallapies D, Obermüller-Jevic UC, Schröder FH. Comment on J Natl Cancer Inst. 2003 Nov 5;95(21):1578-86. doi: 10.1093/jnci/djg081.

The effect of lycopene alone or in association with other antioxidants was studied on the growth of two different human prostate carcinoma cell lines (the androgen insensitive DU-145 and PC-3). It was found that lycopene alone was not a potent inhibitor of prostate carcinoma cell proliferation. However, the simultaneous addition of lycopene together with alpha-tocopherol, at physiological concentrations (less than 1 microM and 50 microM, respectively), resulted in a strong inhibitory effect of prostate carcinoma cell proliferation, which reached values close to 90 %. The effect of lycopene with alpha-tocopherol was synergistic and was not shared by beta-tocopherol, ascorbic acid and probucol. Copyright 1998 Academic Press.

Beta-carotene, canthaxanthin and retinoic acid (RA) inhibited growth of human DU145 prostate cancer cells by 45, 56 and 18%, respectively. Lycopene was also found to inhibit cell growth. Other carotenoids including xanthophyll (lutein), cryptoxanthin and zeaxanthin were less effective. Liarozole (a novel imidazole-derived inhibitor of intracellular RA catabolism) had a modest effect upon cell growth, this drug significantly amplified the pro-apoptotic actions of beta-carotene and RA. RA-induced expression of thymosin beta-10, an apoptotic accelerant, was associated with increased nuclear DNA nicking as measured using TUNEL. Liarozole enhanced the proapoptotic actions of RA upon DNA fragmentation in a dose-dependent manner. These actions were accompanied by inhibition of the cell survival factor bcl-2. Liarozole may thus prove useful as a novel chemotherapeutic/chemopreventive agent by boosting retinoid-induced apoptosis in the prostate.

BACKGROUND: Radiotherapy for prostate cancer often leads to gastrointestinal toxicity, weight gain, fatigue, and reduced quality of life. Nutrition and lifestyle interventions are increasingly used in cancer care, yet evidence specific to men receiving radiotherapy remains limited. METHODS: We systematically searched PubMed, Embase, Web of Science, and the Cochrane Library to June 2025 for studies evaluating nutrition and lifestyle interventions in adults undergoing radiotherapy for prostate cancer. Study quality was assessed using the Cochrane Risk of Bias tool, Newcastle-Ottawa Scale, and ROBINS-I. RESULTS: Nineteen studies were included. In radiotherapy-specific trials, individualized nutrition interventions showed potential to attenuate weight gain and manage gastrointestinal symptoms, while restrictive dietary modifications alleviated bowel complaints but were associated with declines in energy intake and nutritional status. Tomato-juice supplementation increased lycopene levels without consistent clinical benefit. In mixed-modality cohorts, dietary modifications were associated with meaningful weight loss and favorable changes in triglycerides, HDL, and HbA1c. Comprehensive lifestyle programs improved psychological distress, urinary symptoms, and quality of life. CONCLUSIONS: Nutrition and lifestyle interventions show promising signals for improving weight control, symptoms, metabolic profiles, and quality of life during radiotherapy. Given the heterogeneity of evidence, more robust, radiotherapy-specific randomized trials with standardized endpoints are needed to confirm efficacy.

Background/Objectives: The potential influence of lycopene on mental health was indicated in some studies, but it was not summarized within any systematic review so far. The aim of the presented study was to analyze the influence of lycopene on mental health within a systematic review of Randomized Controlled Trials (RCTs). Methods: The study was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, and it was based on PubMed, Web of Science, Cochrane, and Google Scholar databases, while the RCTs published until February 2025 were included. The systematic review was registered within the database of the International Prospective Register of Systematic Reviews (PROSPERO) (CRD420250650525). The studies were considered where the adult population was studied; intervention was based on oral lycopene intake in any form (lycopene supplement, lycopene-enriched functional food, or regular food product being an important source of lycopene); lycopene intake of a specified dose was applied; any mental health result was studied using a valid psychological measure. After duplicate removal, 642 studies were screened, and finally, six RCTs were included and assessed using the revised Cochrane risk-of-bias tool for randomized trials, while various mental health outcomes were allowed (excluding subjects with intellectual disabilities, eating disorders, and neurological disorders). Each stage of screening, inclusion, reporting, and assessment was conducted independently by two researchers. Results: The included studies were conducted in populations of healthy individuals (one study), but mainly in individuals with various diseases: Benign Prostatic Hyperplasia (BPH) (two studies), Burning Mouth Syndrome (BMS) (one study), xerostomia (one study), and infertility (one study). Within the included studies, various lycopene sources were applied, including lycopene supplements, functional foods, and regular food products, as well as various lycopene doses from 1.35 mg to 27.8 mg per day. The included studies assessed quality of life (five studies), depression and anxiety (two studies), stress (two studies), and mood states (o

The most common somatic alteration in primary prostate cancer is the TMPRSS2:ERG gene fusion, which may be caused or promoted by distinct etiologic factors. The objective of this systematic review was to assess epidemiologic evidence on etiologic factors for prostate cancer by tumor TMPRSS2:ERG fusion status in human populations. Of 3071 publications identified, 19 cohort or case-control studies from six distinct study populations were included in this systematic review. Etiologic factors included germline genetic variants, circulating hormones, and dietary and lifestyle factors. Taller height, higher total and free testosterone levels, and fewer trinucleotide repeats in AR were possibly associated with higher risk of TMPRSS2:ERG-positive prostate cancer. Excess body weight, greater vigorous physical activity, higher lycopene intake, and the use of calcium channel blockers were associated with lower risk of TMPRSS2:ERG-positive prostate cancer. Diabetes and family history of prostate cancer were associated with both TMPRSS2:ERG-positive and TMPRSS2:ERG-negative prostate cancer. Prostate cancer germline variants had suggestive differential associations with TMPRSS2:ERG-positive or TMPRSS2:ERG-negative prostate cancer. However, results were based on few distinct study populations and generally had low precision, underscoring the need for replication. In conclusion, prostate cancer with TMPRSS2:ERG fusion is an etiologically distinct subtype that may be, in part, preventable by addressing modifiable and hormonally acting etiologic factors that align with the established mechanistic role of TMPRSS2:ERG in androgen, insulin, antioxidant, and growth factor pathways. © 2024 The Author(s). International Journal of Cancer published by John Wiley & Sons Ltd on behalf of UICC.

Lycopene is a nutraceutical with health-promoting and anti-cancer activities, but due to a lack of evidence, there are no recommendations regarding its use and dosage. This review aimed to evaluate the benefits of lycopene supplementation in cancer prevention and treatment based on the results of in vivo studies. We identified 72 human and animal studies that were then analysed for endpoints such as cancer incidence, improvement in treatment outcomes, and the mechanisms of lycopene action. We concluded that the results of most of the reviewed in vivo studies confirmed the anti-cancer activities of lycopene. Most of the studies concerned prostate cancer, reflecting the number of in vitro studies. The reported mechanisms of lycopene action in vivo included regulation of oxidative and inflammatory processes, induction of apoptosis, and inhibition of cell division, angiogenesis, and metastasis formation. The predominance of particular mechanisms seemed to depend on tumour organ localisation and the local storage capacity of lycopene. Finally, there is a need to look for predictive factors to identify a population that may benefit from lycopene supplementation. The potential candidates appear to be race, single nucleotide polymorphisms in carotene-cleaving enzymes, some genetic abbreviations, and insulin-like growth factor-dependent and inflammatory diseases.

Comment in J Urol. 2022 Jan;207(1):211-213. doi: 10.1097/JU.0000000000002277. Lycopene is a potent lipophilic antioxidant in tomato. We aim to clarify the evidence for associations between tomato and lycopene and multiple health outcomes. Umbrella review of meta-analyses and systematic reviews was performed in humans. A total of 174 articles were searched, 17 articles with 20 health outcomes were identified by eligibility criteria. Tomato intake was inversely associated with all-cause mortality, coronary heart disease mortality, cerebrovascular disease mortality, prostate cancer, and gastric cancer. Dietary lycopene intake or serum lycopene was inversely associated with all-cause mortality, prostate cancer, stroke, cardiovascular disease, metabolic syndrome, and male infertility. Caution was warranted for potential allergy and pollution. The quality of the vast majority of evidence by GRADE was low or very low with the remaining six as moderate. The intake of tomato or lycopene was generally safe and beneficial for multiple health outcomes in humans. But the quality of the evidence was not high.

OBJECTIVE: Male infertility is a wide spread disease among couple of childbearing age. Spermatozoa are highly susceptible to oxidative stress. Reactive oxygen species (ROS) are capable of damaging the sperm membrane and DNA, inducing lipid peroxidation and sperm DNA fragmentation (SDF). Antioxidant supplementation is currently suggested after a complete diagnostic work-up, as recognized by the Italian Society of Andrology and Sexual Medicine (SIAMS). Indeed, it has been showed to improve sperm quality, DNA fragmentation and pregnancy rate. The administration of Serenoa repens extracts (SrE), including free fatty acids (FFA), methyl and ethyl esters, glycerides, flavonoids and sterols, has never been investigated for male infertility. However, their antioxidant and anti-inflammatory properties provide the rational for their possible effectiveness. The aim of this review was to collect all the evidence supporting the potential usefulness of SrE, alone or in combination with other molecules with proven antioxidant effects, like selenium and lycopene (along with which they are often commercialized), to improve sperm parameters. MATERIALS AND METHODS: A systematic search was performed using Pubmed, MEDLINE, Cochrane, Academic One Files, Google Scholar and Scopus databases. The search strategy included the following key words: Serenoa repens, selenium, lycopene, oligozoospermia, oxidative stress, DNA fragmentation, male infertility, pregnancy rate. CONCLUSIONS: By triggering multiple inflammatory and oxidative pathways, the combined administration of SrE, selenium and lycopene might likely improve the sperm quality. Proper studies are needed to test this hypothesis. Finally, since prostatitis can affect the sperm quality and considering the anti-estrogenic properties of SrE, we speculate about a possible specific indication in those patients with male infertility and "metabolic" prostatitis (where obesity and abnormal androgen/estrogen ratio concomitantly occur).

First-line therapy for advanced or metastatic prostate cancer (PCa) involves the removal of tumor-promoting androgens by androgen deprivation therapy (ADT), resulting in transient tumor regression. Recurrent disease is attributed to tumor adaptation to survive, despite lower circulating androgen concentrations, making the blockage of downstream androgen signaling a chemotherapeutic goal for PCa. Dietary intake of tomato and its predominant carotenoid, lycopene, reduce the risk for PCa, and preclinical studies have shown promising results that tomato and lycopene can inhibit androgen signaling in normal prostate tissue. The goal of this systematic review was to evaluate whether mechanistic evidence exists to support the hypothesis that tomato or lycopene interact with the androgen axis in PCa. Eighteen studies (n = 5 in vivo; n = 13 in vitro) were included in the final review. A formal meta-analysis was not feasible due to variability of the data; however, the overall estimated directions of effect for the compared studies were visually represented by albatross plots. All studies demonstrated either null or, more commonly, inhibitory effects of tomato or lycopene treatment on androgen-related outcomes. Strong mechanistic evidence was unable to be ascertained, but tomato and lycopene treatment appears to down-regulate androgen metabolism and signaling in PCa.

OBJECTIVE: To evaluate the efficacy of lycopene intake in primary prevention of prostate cancer (PCa). METHODS: A systematic search of the literature was conducted in March 2015 and the articles published between the years 1990-2015 were reviewed. The following search terms were used: prostate cancer, prostatic neoplasm, lycopene, prevention, effectiveness and efficacy (MeSH). Publications including research in humans, written in English and whose texts were accessible were reviewed. The types of studies included were: clinical trials, cohort and case-control studies. We found 343 articles; of these, 27 were included in the systematic review. After the latter were rigorously analyzed, 23 were included in the meta-analysis using the pooled odds ratios (OR) and risk ratios (RR) of case-control and cohort studies, respectively, and their confidence intervals (95% CI), using random-effects models with Review Manager 5.2. RESULTS: Out of the 27 articles included in the systematic review, 22 were case-control and 5 were cohort studies. For the case-control studies, the total number of patients with PCa was 13,999 and the total number of controls 22,028. Cohort studies included 187,417 patients and PCa was diagnosed in 8,619 of these. The metaanalysis determined an OR = 0.94 (IC 95% 0.89-1.00) and RR = 0.9 (IC 95% 0.85-0.95) of PCa related with lycopene and/or raw or cooked tomatoes intake. CONCLUSIONS: Although our study found that there is a statistically significant inverse association between lycopene intake and PCa, the magnitude of this association is weak and comes solely from observational studies, which do not allow recommending its use as a standard of practice. High-quality randomized clinical trials are required to clarify current evidence.