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Genital Diseases, Male

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Omega 3 Fatty Acid

English Walnut

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

walnuts

usual diet

phone counseling with dietitian

Yunhee Choi-Kuaea, MSW

Stephen Freedland, MD

Aubrey Jarman, RD

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.

The overall objective of this study is to test the effect of walnuts added to a usual diet on prostate cancer progression as measured by Ki67 expression in the prostate tissues. Subjects will be randomized 1:1 to usual diet or usual diet with the addition of 2 ounces of walnuts daily. The baseline visit will occur in conjunction with a standard of care visit post-biopsy, the intervention period will range from 4-10 weeks dependent upon the scheduled date of the standard of care radical prostatectomy (RP), and the final visit will occur in conjunction with a standard of care visit prior to RP.

WALNUTS for POWER: Polyphenols, Omega-3 Fatty Acids, Weight Loss, and EneRgy

Measured by prostate tissue 8-hydroxy-2-deoxyguanosine

Measured by 8-hydroxy-2-deoxyguanosine and immune cell infiltration

California Walnut Commission

Stephen Freedland

Professor, Surgery

Carbohydrate restricted diet and phone counseling with dietitian. After 6 months, patients will crossover to a non-restricted diet.

Non-restricted diet and after 6 months, patients will crossover to a carbohydrate restricted diet and phone counseling with dietitian

Carbohydrate restricted diet

Non-restricted diet

Phone counseling with dietitian

This phase 2 waitlist-controlled, randomized trial is designed to compare the difference in proliferative index (Ki67) between carbohydrate restricted diet and usual care over a 6 month period in men with prostate cancer who have been placed on Active Surveillance. Eligible patients include men over 18 years old, BMI \>25, with their most recently performed biopsy pathologically confirming prostate adenocarcinoma who have been placed on AS. Arms of the trial will be randomized 1:1 in a crossover approach, with Arm A receiving a carb restricted diet over 6 months then SOC and Arm B receiving the waitlist control arm (i.e. SOC then allowed to go on diet after 6 months). Ki67 will be performed on tissue from the most recent biopsy at the beginning of the study and again on tissue obtained in the 6 month SOC biopsy. Every patient will be on the study for 12 months, and the study will continue for approximately 3.5 years.

Carbohydrate Restricted Diet Intervention for Men on Prostate Cancer Active Surveillance

Carbohydrate and Prostate Study 3: Carbohydrate Restricted Diet Intervention for Men on Prostate Cancer Active Surveillance

Proliferative index is measured by Ki67/apoptosis rate

AUA intermediate risk is PSA \> 10ng/ml or grade group ≥ 2 or clinical stage ≥ T2b

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
WALNUTS for POWER: Polyphenols, Omega-3 Fatty Acids, Weight Loss, and EneRgy	NCT03824652	Prostate Cancer	walnuts usual diet phone counselin...	18 Years -	Cedars-Sinai Medical Center
Carbohydrate Restricted Diet Intervention for Men on Prostate Cancer Active Surveillance	NCT03679260	Prostate Cancer	Carbohydrate re... Non-restricted ... Phone counselin...	18 Years -	Cedars-Sinai Medical Center

Spots Global Cancer Trial Database for phone counseling with dietitian