NCT03824652

Brief Summary

This is a randomized control trial testing the effect of walnut supplementation on prostate cancer progression in 50 men with biopsy confirmed prostate cancer and planning to undergo RP. Patients consented to the study will be randomly assigned to either continue their usual diets (control arm) or to the walnut arm for 4-10 weeks depending on the window between their consent date and the date for RP.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for phase_2 prostate-cancer

Timeline
13mo left

Started Apr 2019

Longer than P75 for phase_2 prostate-cancer

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress87%
Apr 2019Jun 2027

First Submitted

Initial submission to the registry

January 29, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 31, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

April 22, 2019

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2027

Last Updated

February 4, 2026

Status Verified

February 1, 2026

Enrollment Period

7.1 years

First QC Date

January 29, 2019

Last Update Submit

February 2, 2026

Conditions

Prostate Cancer

Keywords

prostate cancerprostate adenocarcinomadietwalnutsradical prostatectomyomega-3 fatty acidspolyphenols

Outcome Measures

Primary Outcomes (1)

  • Mean difference in prostatic tissue Ki67 expression from baseline biopsy to RP

    10 weeks

Secondary Outcomes (2)

  • Mean difference in prostatic tissue oxidative stress from baseline biopsy to RP

    10 weeks

  • Mean difference in prostatic tissue inflammation from baseline biopsy to RP

    10 weeks

Study Arms (2)

Usual Diet + Walnuts

EXPERIMENTAL

Usual diet with the addition of two ounces of walnuts daily, phone counseling with dietitian, for 4-10 weeks

Other: walnutsOther: usual dietOther: phone counseling with dietitian

Usual Diet

ACTIVE COMPARATOR

Usual diet for 4-10 weeks

Other: usual diet

Interventions

walnutsOTHER

2 ounces of walnuts daily for 4-10 weeks

Usual Diet + Walnuts
usual dietOTHER

Subject continues usual diet

Usual DietUsual Diet + Walnuts
phone counseling with dietitianOTHER

Weekly calls with dietitian

Usual Diet + Walnuts

Eligibility Criteria

Age18 Years+
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Pathologically confirmed prostate adenocarcinoma.
  • Diagnostic biopsy cores with ≥10 cores with each core examined separately to determine exact tumor location.
  • Biopsy grade group 2 or higher (Gleason ≥7).
  • Planning to undergo RP.
  • Willing to adhere to a usual diet with the possible addition of 2 oz of walnuts per day.
  • Reads, writes, and understands English.
  • Age 18 or older

You may not qualify if:

  • Allergy to nuts.
  • History of receiving hormone therapy or antiandrogen therapy.
  • Use of 5-alpha reductase inhibitors in the past 6 months.
  • Prior prostate radiotherapy (external beam or brachytherapy) or prior prostate cryotherapy.
  • Currently enrolled in a modified diet/weight loss program and/or taking dietary supplements that contain omega-3s (e.g., fish oil).
  • Other active malignancy, excluding basal cell carcinoma or squamous cell carcinoma
  • Significant co-morbidities (e.g., cardiac, pulmonary, liver disease, alcohol/drug addiction, malabsorption syndromes), that in the opinion of the study physician make the patient ineligible.
  • Individuals with psychological/mental conditions which can affect the consent process and/or their adherence to the protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

Durham VA Medical Center

Durham, North Carolina, 27705, United States

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Interventions

Nutritionists

Condition Hierarchy (Ancestors)

Genital Neoplasms, MaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, MaleGenital DiseasesUrogenital DiseasesProstatic DiseasesMale Urogenital Diseases

Intervention Hierarchy (Ancestors)

Health PersonnelHealth Care Facilities Workforce and Services

Study Officials

  • Stephen Freedland, MD

    Cedars-Sinai Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yunhee Choi-Kuaea, MSW

CONTACT

310-423-0333Yunhee.Choi-Kuaea@cshs.org

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, Surgery

Study Record Dates

First Submitted

January 29, 2019

First Posted

January 31, 2019

Study Start

April 22, 2019

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2027

Last Updated

February 4, 2026

Record last verified: 2026-02

Locations

US(2)