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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02759380
Recruitment Status : Recruiting
First Posted : May 3, 2016
Last Update Posted : November 26, 2018
Sponsor:
Collaborator:
Göteborg University
Information provided by (Responsible Party):
Maria Hedelin, Sahlgrenska University Hospital, Sweden

Brief Summary:

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: Phytoestrogen-rich foods
  • Introduced to the study by a dietitian.
  • Receive general information about healthy food choices (according to the Swedish National Food Agency's recommendations for the general public).
  • Be told not not to eat any dietary supplements, though no other dietary restrictions will be given.
  • Called one time during the study and perform a 24-hour recall.
  • The intervention continues until the day before the surgery (at least 6 weeks).
  • The patients in the experimental group will be given a package containing food with a high amount of phytoestrogens.
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
  • Introduced to the study by a dietitian.
  • Receive general information about healthy food choices (according to the Swedish National Food Agency's recommendations for the general public).
  • Be told not not to eat any dietary supplements, though no other dietary restrictions will be given.
  • Called one time during the study and perform a 24-hour recall.
  • The intervention continues until the day before the surgery (at least 6 weeks).



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. PSA-levels [ Time Frame: Blood samples obtained at baseline and at day before surgery. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • men in the Västra Götaland healthcare region
  • diagnosed with prostate cancer of intermediate risk-level (T1-T2, Gleason score <8 and PSA<20)
  • scheduled for radical prostatectomy

Exclusion Criteria:

  • ongoing hormonal treatment.
  • other difficult physical or psychological conditions
  • diminished cognitive function
  • allergy to soy
  • having taken dietary supplements regularly (daily) during the preceding three months
  • does not understand written Swedish

Information from the National Library of Medicine

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


Contacts
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Contact: Maria Hedelin, P.hD +4670-7401858 maria.hedelin@oncology.gu.se
Contact: Rebecca Ahlin +4676-6185130 rebecca.ahlin@vgregion.se

Locations
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Sweden
Sahlgrenska University Hospital Recruiting
Gothenburg, Västra Götalands Län, Sweden, 41326
Principal Investigator: Maria Hedelin, PhD         
Sponsors and Collaborators
Sahlgrenska University Hospital, Sweden
Göteborg University
Investigators
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Principal Investigator: Maria Hedelin, P.hD Principal Investigator
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Responsible Party: Maria Hedelin, P.hd, nutritionist, Sahlgrenska University Hospital, Sweden
ClinicalTrials.gov Identifier: NCT02759380    
Other Study ID Numbers: 410-14
First Posted: May 3, 2016    Key Record Dates
Last Update Posted: November 26, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Phytoestrogens
Estrogens, Non-Steroidal
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs