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Report for Clinical Trial NCT02759380

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

Can Dietary Phytoestrogens Slow Down Prostate Tumor Proliferation? A Randomized Study (PRODICA)

The purpose of this study is to evaluate if a diet with a high content of phytoestrogens can slow down the prostate tumor proliferation. Phytoestrogens are found in food items such as soy, rye, and seeds. Two hundred thirty men with prostate cancer will be included in the study and followed until surgery (at least 6 weeks). Half of the study participants will receive general information about healthy food choices and a package of foods with high content of phytoestrogens to add to their food. The other half will get the same information but not receive the food-package.

NCT02759380 Prostate Cancer
MeSH:Prostatic Neoplasms
HPO:Prostate cancer Prostate neoplasm

1 Interventions

Name: Phytoestrogen-rich foods

Description: The patients will be given a package containing food with a high amount of phytoestrogens (≥100 mg isoflavonoids and ≥100 mg lignans) that are to be consumed daily. The food-package contains 30 grams of flaxseed, 25 grams of roasted soybeans and 50 grams of frozen green edamame beans to be consumed daily.
Type: Other
Group Labels: 1

Phytoestrogen-rich foods

Primary Outcomes

Description: Ki-67 is measured in tumor cells which are obtained from specimens from the prostate.

Measure: Percentage of positive stained cells with Ki-67

Time: The specimens will be obtained first from a biopsy from when the prostate cancer is found, the other biopsy is obtained after radical prostatectomy surgery. Approximate time between the first and second biopsy is 3-6 months.

Secondary Outcomes

Measure: PSA-levels

Time: Blood samples obtained at baseline and at day before surgery.

Purpose: Prevention

Allocation: Randomized

Parallel Assignment

There is one SNP


1 rs2987983

The men will be divided into two subgroups, those bearing TT or TC/CC alleles, of the single-nucleotide polymorphism (SNP) rs2987983-13950 T/C in the ERß-gene, in which the hypothesis will be tested.

The investigators found in earlier studies that approximately 42 % of the male population are heterozygous or homozygous for the variant allele (TC/CC) of the ERβ promoter region SNP (rs2987983-13950 T/C) and 58 % homozygous for the wild type allele (TT).

HPO Nodes