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

Primary Purpose

Prostate Cancer

Status

Completed

Phase

Phase 1

Locations

Norway

Study Type

Interventional

Intervention

Prostate cancer, phytochemical and PUFA

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Prostate cancer, PSA, antioxidant, phytochemical, tomatoes, PUFA, selenium, soy, pomegranate, grapes

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Oslo Universuty Hospital, Radiumhospitalet and Aker

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Tomato

Multi-diet

Control

Outcomes

Primary Outcome Measures

serum prostate specific antigen

Secondary Outcome Measures

oxidative stress biomarkers in blood, tissue and urine

antioxidant status biomarkers in blood, tissue and urine

oxidative damage biomarkers in blood, tissue and urine

inflammation biomarkers in blood, tissue and urine

Apoptose markers in prostate tissue

DNA microarrays in blood cells and prostate tissue

Full Information

NCT ID

NCT00433797

First Posted

February 9, 2007

Last Updated

December 18, 2013

Sponsor

University of Oslo

Collaborators

Oslo University Hospital, Norwegian Cancer Society, The Research Council of Norway

1. Study Identification

Unique Protocol Identification Number

NCT00433797

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2013

Overall Recruitment Status

Completed

Study Start Date

June 2007 (undefined)

Primary Completion Date

March 2012 (Actual)

Study Completion Date

December 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Oslo

Collaborators

Oslo University Hospital, Norwegian Cancer Society, The Research Council of Norway

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Prostate Cancer

Keywords

Prostate cancer, PSA, antioxidant, phytochemical, tomatoes, PUFA, selenium, soy, pomegranate, grapes

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1, Phase 2

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

86 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Tomato

Arm Title

Arm Type

Experimental

Arm Description

Multi-diet

Arm Title

Arm Type

Active Comparator

Arm Description

Control

Intervention Type

Dietary Supplement

Intervention Name(s)

Prostate cancer, phytochemical and PUFA

Other Intervention Name(s)

PFPI

Intervention Description

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.

Primary Outcome Measure Information:

Title

serum prostate specific antigen

Time Frame