Can Dietary Phytoestrogens Slow Down Prostate Tumor Proliferation?

NCT02759380 | Unknown

• 1 other identifier: 410-14
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• Percentage of positive stained cells with Ki-67

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

  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 (1)

• PSA-levels

  Blood samples obtained at baseline and at day before surgery.

Study Arms (2)

Phytoestrogen-rich foods

EXPERIMENTAL

* 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

Control group

NO INTERVENTION

* 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).

Interventions

Phytoestrogen-rich foods OTHER

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.

Phytoestrogen-rich foods

Eligibility Criteria

• Sex: male
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Sahlgrenska University Hospital: lead
• Göteborg University: collaborator

Study Sites (1)

Sahlgrenska University Hospital

Gothenburg, Västra Götaland County, 41326, Sweden

RECRUITING

Related Publications (1)

• Ahlin R, Nybacka S, Josefsson A, Stranne J, Steineck G, Hedelin M. The effect of a phytoestrogen intervention and impact of genetic factors on tumor proliferation markers among Swedish patients with prostate cancer: study protocol for the randomized controlled PRODICA trial. Trials. 2022 Dec 21;23(1):1041. doi: 10.1186/s13063-022-06995-2.

  PMID: 36544211 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Maria Hedelin, P.hD

  Principal Investigator

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Hedelin, P.hD

CONTACT

+4670-7401858; maria.hedelin@oncology.gu.se

Rebecca Ahlin

CONTACT

+4676-6185130; rebecca.ahlin@vgregion.se

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: P.hd,Associate professor, nutritionist

Study Record Dates

• First Submitted: April 27, 2016
• First Posted: May 3, 2016
• Study Start: March 1, 2016
• Primary Completion: November 1, 2024
• Study Completion: December 1, 2024
• Last Updated: January 20, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

SE (1)