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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Prostate Cancer

Intervention / Treatment
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* Other: walnuts
* Other: usual diet
* Other: phone counseling with dietitian


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Usual Diet + Walnuts<br>Usual diet with the addition of two ounces of walnuts daily, phone counseling with dietitian, for 4-10 weeks | Other: walnuts<br>* 2 ounces of walnuts daily for 4-10 weeks<br>Other: usual diet<br>* Subject continues usual diet<br>Other: phone counseling with dietitian<br>* Weekly calls with dietitian<br>|
| Active Comparator: Usual Diet<br>Usual diet for 4-10 weeks | Other: usual diet<br>* Subject continues usual diet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean difference in prostatic tissue Ki67 expression from baseline biopsy to RP |  | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean difference in prostatic tissue oxidative stress from baseline biopsy to RP | Measured by prostate tissue 8-hydroxy-2-deoxyguanosine | 10 weeks | 
| Mean difference in prostatic tissue inflammation from baseline biopsy to RP | Measured by 8-hydroxy-2-deoxyguanosine and immune cell infiltration | 10 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prostate cancer, prostate adenocarcinoma, diet, walnuts, radical prostatectomy, omega-3 fatty acids, polyphenols