Dietary Intervention With Phytochemicals and Polyunsaturated Fatty Acids in Prostate Cancer Patients

Phase 1

Completed

• Conditions: Prostate Cancer
• Interventions: Dietary Supplement: Prostate cancer, phytochemical and PUFA

• Registration Number: NCT00433797
• Lead Sponsor: University of Oslo

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.

Study Timeline

• Study First Submitted: 2007-02-09
• Study First Submitted QC: 2007-02-09
• Study First Posted: 2007-02-12
• Study Start: 2007-06
• Primary Completion: 2012-03
• Status Verified: 2013-12
• Study Completion: 2013-12
• Last Update Submitted: 2013-12-18
• Last Update Posted: 2013-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 86

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Prostate cancer, phytochemical and PUFA	Tomato
2	Prostate cancer, phytochemical and PUFA	Multi-diet
3	Prostate cancer, phytochemical and PUFA	Control

Primary Outcome Measures

Name	Time	Method
serum prostate specific antigen	Baseline, after intervention, follow-up

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Oslo Universuty Hospital, Radiumhospitalet and Aker; 🇳🇴 Oslo, Norway