Format

Send to

Choose Destination
Cancer Prev Res (Phila). 2018 Nov;11(11):687-696. doi: 10.1158/1940-6207.CAPR-18-0147. Epub 2018 Oct 11.

ProDiet: A Phase II Randomized Placebo-controlled Trial of Green Tea Catechins and Lycopene in Men at Increased Risk of Prostate Cancer.

Author information

1
Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, United Kingdom. athene.lane@bristol.ac.uk.
2
NIHR Biomedical Research Centre at University Hospitals Bristol NHS Foundation Trust and the University of Bristol, Bristol, United Kingdom.
3
Bristol Randomised Trials Collaboration, University of Bristol, Bristol, United Kingdom.
4
Population Health Sciences, Bristol Medical School, University of Bristol, Bristol, United Kingdom.
5
Collaboration for Leadership in Applied Health Research and Care West at University Hospitals Bristol NHS Foundation Trust, Bristol, United Kingdom.
6
Institute for Global Food Security, School of Biological Sciences, Queen's University Belfast, Belfast, United Kingdom.
7
Department of Food and Health, IFAPA-Alameda del Obispo, Cordoba, Spain.
8
Department of Nutrition, University of California Davis, Davis, California.
9
Medical Research Council Integrative Epidemiology Unit, University of Bristol, Bristol, United Kingdom.
10
Nuffield Department of Surgical Sciences, University of Oxford, Oxford, United Kingdom.
11
Bristol Urological Institute, North Bristol Trust, Bristol, United Kingdom.
12
IGFs and Metabolic Endocrinology Group, Translational Health Sciences, Bristol Medical School, University of Bristol, Bristol, United Kingdom.

Abstract

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 × 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. Cancer Prev Res; 11(11); 687-96. ©2018 AACR.

Supplemental Content

Full text links

Icon for HighWire
Loading ...
Support Center