Can Dietary Phytoestrogens Slow Down Prostate Tumor Proliferation? (PRODICA)
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|ClinicalTrials.gov Identifier: NCT02759380|
Recruitment Status : Recruiting
First Posted : May 3, 2016
Last Update Posted : November 26, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Other: Phytoestrogen-rich foods||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Can Dietary Phytoestrogens Slow Down Prostate Tumor Proliferation? A Randomized Study (PRODICA)|
|Study Start Date :||March 2016|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||January 2020|
Experimental: Phytoestrogen-rich foods
Other: Phytoestrogen-rich foods
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.
No Intervention: Control group
- Percentage of positive stained cells with Ki-67 [ Time Frame: 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. ]Ki-67 is measured in tumor cells which are obtained from specimens from the prostate.
- PSA-levels [ Time Frame: Blood samples obtained at baseline and at day before surgery. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02759380
|Contact: Maria Hedelin, P.hDfirstname.lastname@example.org|
|Contact: Rebecca Ahlinemail@example.com|
|Sahlgrenska University Hospital||Recruiting|
|Gothenburg, Västra Götalands Län, Sweden, 41326|
|Principal Investigator: Maria Hedelin, PhD|
|Principal Investigator:||Maria Hedelin, P.hD||Principal Investigator|