Prostate Phytochemical & PUFA Intervention - a Phase I/II Study
A total of 102 patients with localized prostate cancer will be included in the study. A the
time of inclusion, the participants will be randomized to three groups.
The intervention groups includes; control group, tomato group and multi-diet group. The
intervention period is three week and will be completed before prostatectomy or radiation
Biomarkers og inflammation includes: acute phase proteins, cytokines, chemokines and other
inflammatory mediators. Biomarker of antioxidant status includes vitamin C, vitamin E,
glutathione, carotenoids, total antioxidant capacity and total phenolics. Oxidative stress
markers includes; malondialdehyde, isoprostanes, 8-hydroxy-deoxyguanosine, oxidized vitamin
C, total lipidperoxides (d-ROM) and protein carbonyls.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
serum prostate specific antigen
Baseline, after intervention, follow-up
Wolfgang Lilleby, MD
Norway: Directorate of Health