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Completed

NCT Number: NCT00433797

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

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

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Key information

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Oslo Universuty Hospital, Radiumhospitalet and Aker

Oslo, 0310, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prostate cancer, phytochemical and PUFA

Dietary Supplement

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.

Other names: PFPI

Primary outcomes

  1. serum prostate specific antigen

    Time frame: Baseline, after intervention, follow-up

Secondary outcomes

  1. oxidative stress biomarkers in blood, tissue and urine

    Time frame: Baseline, after intervention, follow-up

  2. antioxidant status biomarkers in blood, tissue and urine

    Time frame: Baseline, after intervention, follow-up

  3. oxidative damage biomarkers in blood, tissue and urine

    Time frame: Baseline, after intervention, follow-up

  4. inflammation biomarkers in blood, tissue and urine

    Time frame: Baseline, after intervention, follow-up

  5. Apoptose markers in prostate tissue

    Time frame: Baseline, after intervention, follow-up

  6. DNA microarrays in blood cells and prostate tissue

    Time frame: Baseline, after intervention, follow-up

Sponsors and collaborators

Lead sponsor

University of Oslo

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2012
Study completion
2013
First posted
Feb 12, 2007
Registry last updated
Dec 19, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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