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Lycopene intake and prostate cancer risk in men at high cardiovascular risk: a prospective cohort study.

  • 2025-11-10
  • BMC medicine 23(1)
    • Ricardo López-Solís
    • Sara Castro-Barquero
    • Carolina Donat-Vargas
    • Marina Corrado
    • Camila Arancibia-Riveros
    • Miguel Ángel Martínez-González
    • Jordi Salas-Salvadó
    • Jose V Sorlí
    • Luis Serra-Majem
    • Montserrat Fitó
    • Xavier Pintó
    • Miquel Fiol
    • José Lapetra
    • Enrique Gómez-Gracia
    • Estefanía Toledo
    • Judith B Ramírez-Sabio
    • Nancy Babio
    • Ramón Estruch
    • Emilio Ros
    • Rosa M Lamuela-Raventós

Study Design

Type
Randomized Controlled Trial (RCT)
Sample size
n = 2,970
Population
2970 men aged 55-80 years at high cardiovascular risk from the PREDIMED trial
Methods
Prospective cohort analysis, lycopene intake assessed using repeated food frequency questionnaires, Cox proportional hazard models
Duration
mean follow-up of 5.8 years
  • Large Human Trial

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).

Research Insights

  • Blood Orange→Reduced Prostate Cancer Risk

    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).

    Effect
    Beneficial
    Effect size
    Large
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