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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Prostate Phytochemical & PUFA Intervention - a Phase I/II Study

Conditions
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Prostate Cancer

Intervention / Treatment
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* Dietary Supplement: Prostate cancer, phytochemical and PUFA


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Tomato | Dietary Supplement: Prostate cancer, phytochemical and PUFA<br>* 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.<br>* Other names: PFPI;|
| Experimental: 2<br>Multi-diet | Dietary Supplement: Prostate cancer, phytochemical and PUFA<br>* 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.<br>* Other names: PFPI;|
| Active Comparator: 3<br>Control | Dietary Supplement: Prostate cancer, phytochemical and PUFA<br>* 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.<br>* Other names: PFPI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum prostate specific antigen |  | Baseline, after intervention, follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oxidative stress biomarkers in blood, tissue and urine |  | Baseline, after intervention, follow-up | 
| 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 | 
| inflammation 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Prostate cancer, PSA, antioxidant, phytochemical, tomatoes, PUFA, selenium, soy, pomegranate, grapes