Prostate Cancer
Conditions
Keywords
prostate cancer, prostate adenocarcinoma, diet, walnuts, radical prostatectomy, omega-3 fatty acids, polyphenols
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.
Detailed description
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.
Interventions
OTHERwalnuts
2 ounces of walnuts daily for 4-10 weeks
OTHERusual diet
Subject continues usual diet
Weekly calls with dietitian
Sponsors
Stephen Freedland
California Walnut Commission
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean difference in prostatic tissue Ki67 expression from baseline biopsy to RP | 10 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mean difference in prostatic tissue oxidative stress from baseline biopsy to RP | 10 weeks | Measured by prostate tissue 8-hydroxy-2-deoxyguanosine |
| Mean difference in prostatic tissue inflammation from baseline biopsy to RP | 10 weeks | Measured by 8-hydroxy-2-deoxyguanosine and immune cell infiltration |
Countries
United States
Contacts
CONTACTYunhee Choi-Kuaea, MSW
PRINCIPAL_INVESTIGATORStephen Freedland, MD
Cedars-Sinai Medical Center
Outcome results
None listed