Prostate Phytochemical & PUFA Intervention - a Phase I/II Study
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Prostate Cancer
- Sponsor
- University of Oslo
- Enrollment
- 86
- Locations
- 1
- Primary Endpoint
- serum prostate specific antigen
- Status
- Completed
- Last Updated
- 12 years ago
Overview
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.
Investigators
Rune Blomhoff
Professor
University of Oslo
Eligibility Criteria
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
Outcomes
Primary Outcomes
serum prostate specific antigen
Time Frame: Baseline, after intervention, follow-up
Secondary Outcomes
- 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)
- antioxidant status biomarkers in blood, tissue and urine(Baseline, after intervention, follow-up)
- inflammation biomarkers in blood, tissue and urine(Baseline, after intervention, follow-up)
- DNA microarrays in blood cells and prostate tissue(Baseline, after intervention, follow-up)