Prodiet: a phase II randomized placebo-controlled trial of green tea catechins and lycopene in men at increased risk of prostate cancer

J. Athene Lane*, Vanessa Er, Kerry N. L. Avery, Jeremy Horwood, Marie Cantwell, Gema P. Caro, Alan Crozier, George Davey Smith, Jenny L. Donovan, Liz Down, Freddie C. Hamdy, David Gillatt, Jeff Holly, Rhiannon Macefield, Hilary Moody, David E. Neal, Eleanor Walsh, Richard M. Martin, Chris Metcalfe

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

32 Citations (Scopus)


Epidemiologic studies suggest that diet can alter prostate cancer risk. This study aimed to establish the feasibility and acceptability of dietary modification in men at increased risk of prostate cancer. Men were invited with a PSA level of 2.0-2.95 ng/mL or 3.0-19.95 ng/mL with negative prostate biopsies. Randomization (3 x 3 factorial design) to daily green tea and lycopene: green tea drink (3 cups, unblinded) or capsules [blinded, 600 mg flavan-3-ol ()-epigallocatechin-3-gallate (EGCG) or placebo] and lycopene-rich foods (unblinded) or capsules (blinded, 15 mg lycopene or placebo) for 6 months. Primary endpoints were randomization rates and intervention adherence (blinded assessment of metabolites) at 6 months with secondary endpoints of acceptability (from interviews), safety, weight, blood pressure, and PSA. A total of 133 of 469 (28.4%) men approached agreed to be randomized and 132 were followed-up (99.2%). Mean lycopene was 1.28 [95% confidence intervals (CI), 1.09-1.50, P = 0.003] times higher in the lycopene capsule group and 1.42 (95% CI, 1.21-1.66; P <0.001) times higher in the lycopene-enriched diet group compared with placebo capsules. Median EGCG was 10.7 nmol/L (95% CI, 7.0-32.0) higher in in the active capsule group and 20.0 nmol/L (95% CI, 0.0-19.0) higher in the green tea drink group compared with placebo capsules (both P <0.001). All interventions were acceptable and well tolerated although men preferred the capsules. Dietary prevention is acceptable to men at risk of prostate cancer. This intervention trial demonstrates that a chemoprevention clinical trial is feasible.

Original languageEnglish
Pages (from-to)687-696
Number of pages10
JournalCancer Prevention Research
Issue number11
Publication statusPublished - 1 Nov 2018
Externally publishedYes


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