Localized cancer of the prostate.
Conditions
Interventions
Trade Name: Barilla Pastasauce with basil
Product Name: Barilla Pastasauce with basil
Pharmaceutical Form: Gastroenteral solution
Other descriptive name: Lycopene
Concentration unit: mg milligram(s)
Sponsors
University of Oslo, institute for basic medical sciences, department of nutrition.
Eligibility
Sex/Gender
Male
Inclusion criteria
Inclusion criteria: 1.Histologically verified adenocarsinoma 2.pN0/NXM0 (TNM/UICC 2002) and at least one negative prognostic factor for HDR-BT or low-intermediate risk profile by radical prostatectomi. 3.PSA 6) or T1c- T3a, prostatevolume 11g/dl 6.Life expectancy > 5 år Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Previous endocrine treatment 2. Insulindependent diabetes mellitus, vasculitis, inflammatory bowel disease etc. which might influence quality of life or radiotherapy. 3. Urinary retention, urinary incontinence, IPPS score <12 (HDR-BT patients).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess several dietary products ability to influence the growth rate of localized prostate cancer before radical prostatectomy or radiotherapy. The dietary products studied are tomato products, grape juice, pomegranate juice, tea (green,black), selenium and soy. The growth rate of prostate cancer will be assessed with pseudomarkers as PSA kinetics, proliferationmarkers and apoptosismarkers. In addition the diets effect on tumor microenvironment with respect to to oxidative stress and DNA damage will be described. (oxidative stress markers, COMET assay). ;Secondary Objective: Prostatebiopsies: -Apoptosismarkers (bcl-2, bax) -lycopene and biomarkers for antioxidantstatus -biomarkers for inflammation -DNA damage and biomarkers for oxidative stress -Gene array (cDNA microarray) -Cellulære changes (morphologyi, DNA-ploidi, chromosomal changes) -Molecular changes (proliferationmarkers [Ki-67], hypermetylation of transcripsjonsfactors [ GSTP1, PTEN], expression of steroidreceptors[ AR,ER]) ;Primary end point(s): Serum PSA kinetics after dietary intervention before prostatectomy or brachytherapi. | — |
Countries
Norway
Outcome results
None listed