Recruiting
Phase 2

Walnuts

Sponsor:

Stephen Freedland

Code:

NCT03824652

Conditions

Prostate Cancer

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

walnuts

usual diet

phone counseling with dietitian

Study Details

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.

Conditions

Prostate Cancer

Study ID

NCT03824652

Start date

Apr 22, 2019

Status verified date

Aug, 2026

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Usual Diet + Walnuts

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

active comparator: Usual Diet

Usual diet for 4-10 weeks

Interventions

walnuts

2 ounces of walnuts daily for 4-10 weeks

usual diet

Subject continues usual diet

phone counseling with dietitian

Weekly calls with dietitian

Primary outcome measure

  • Mean difference in prostatic tissue Ki67 expression from baseline biopsy to RP [ Time Frame: 10 weeks ]

Central Contacts and Locations

Central contacts

Clinical Trials Navigator

310-423-5842GroupCancerTrialInformation@cshs.org

Locations

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Kara Bissell

424-314-0743kara.bissell@cshs.org

Principal Investigator:

Stephen Freedland, MD

More Information

Sponsor

Stephen Freedland

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Keywords

  • prostate cancer
  • prostate adenocarcinoma
  • diet
  • walnuts
  • radical prostatectomy
  • omega-3 fatty acids
  • polyphenols

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Stephen Freedland on 2026-08-10.