Prostate Cancer
Conditions
Keywords
Prostate cancer, PSA, antioxidant, phytochemical, tomatoes, PUFA, selenium, soy, pomegranate, grapes
Brief summary
We will study the effect of dietary intervention in patients with prostate cancer. Outcomes include serum PSA kinetics, as well as biomarkers of inflammation, antioxidant status, oxidative stress and oxidative damage in blood cells, plasma, urine and prostate tissues
Detailed description
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 therapy. 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.
Interventions
DIETARY_SUPPLEMENTProstate cancer, phytochemical and PUFA
Patients with localized prostate cancer are supplemented with either tomato or a multi-diet cinsisting of grape juice, pomegranate juice, tomato, green tea, black tea, soy, selenium and PUFAs for 3 weeks.
Sponsors
Oslo University Hospital
Norwegian Cancer Society
The Research Council of Norway
University of Oslo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
Inclusion criteria
* Adenoarcinoma (as confirmed by histology) * pN0/NXM0 (TNM/UICC 2002) and at least one negative prognosis factor for HDR-BT or low risk profile with the use of radical prostatectomy. * Serum PSA\< 20 ng/mL, and Gleason score =\>6 or T1c- T3a, prostate volume \< 60mL * Performance status 0-1 * Normal WBC and thromocytes, Hb \>11g/dl
Exclusion criteria
* No previous endocrine treatment * Life expectancy \> 5 år * No possible co-morbidity (CVD, COPD, diabetes type I, vasculatory syndromes or inflammatory diseases that may affect quality of life and radiation therapy) * Urinary retention, incontinens or IPPS score \<12
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| serum prostate specific antigen | Baseline, after intervention, follow-up |
Secondary
| Measure | Time frame |
|---|---|
| antioxidant status biomarkers in blood, tissue and urine | Baseline, after intervention, follow-up |
| oxidative damage biomarkers in blood, tissue and urine | Baseline, after intervention, follow-up |
| oxidative stress biomarkers in blood, tissue and urine | Baseline, after intervention, follow-up |
| Apoptose markers in prostate tissue | Baseline, after intervention, follow-up |
| DNA microarrays in blood cells and prostate tissue | Baseline, after intervention, follow-up |
| inflammation biomarkers in blood, tissue and urine | Baseline, after intervention, follow-up |
Countries
Norway
Outcome results
None listed