Status:
COMPLETED
Dietary Intervention With Phytochemicals and Polyunsaturated Fatty Acids in Prostate Cancer Patients
Lead Sponsor:
University of Oslo
Collaborating Sponsors:
Oslo University Hospital
Norwegian Cancer Society
Conditions:
Prostate Cancer
Eligibility:
MALE
Phase:
PHASE1
PHASE2
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 ...
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; c...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2013
Estimated Enrollment :
86 Patients enrolled
Trial Details
Trial ID
NCT00433797
Start Date
June 1 2007
End Date
December 1 2013
Last Update
December 19 2013
Active Locations (1)
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1
Oslo Universuty Hospital, Radiumhospitalet and Aker
Oslo, Norway, 0310