Clinical trial NCT00433797: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Prostate Cancer
Keywords: Prostate cancer
PSA
antioxidant
phytochemical
tomatoes
PUFA
selenium
soy
pomegranate
grapes
Lead sponsor: University of Oslo
Sponsor class: OTHER
Collaborators: name: Oslo University Hospital
name: Norwegian Cancer Society
name: The Research Council of Norway
First posted: 2007-02-12
Enrollment: 86
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: serum prostate specific antigen
timeFrame: Baseline, after intervention, follow-up
Secondary outcomes:
measure: oxidative stress biomarkers in blood, tissue and urine
timeFrame: Baseline, after intervention, follow-up
measure: antioxidant status biomarkers in blood, tissue and urine
timeFrame: Baseline, after intervention, follow-up
measure: oxidative damage biomarkers in blood, tissue and urine
timeFrame: Baseline, after intervention, follow-up
measure: inflammation biomarkers in blood, tissue and urine
timeFrame: Baseline, after intervention, follow-up
measure: Apoptose markers in prostate tissue
timeFrame: Baseline, after intervention, follow-up
measure: DNA microarrays in blood cells and prostate tissue
timeFrame: Baseline, after intervention, follow-up
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo Universuty Hospital, Radiumhospitalet and Aker
Study officials:
affiliation: Rikshospitalet-Radiumhospitalet, Oslo
name: Wolfgang Lilleby, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Rikshospitalet-Radiumhospitalet, Oslo
name: Sigbjørn Smeland, MD, PhD.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Paur I, Lilleby W, Bohn SK, Hulander E, Klein W, Vlatkovic L, Axcrona K, Bolstad N, Bjoro T, Laake P, Tasken KA, Svindland A, Eri LM, Brennhovd B, Carlsen MH, Fossa SD, Smeland SS, Karlsen AS, Blomhoff R. Tomato-based randomized controlled trial in prostate cancer patients: Effect on PSA. Clin Nutr. 2017 Jun;36(3):672-679. doi: 10.1016/j.clnu.2016.06.014. Epub 2016 Jun 30.