Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer

Study Overview
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Brief Summary
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The purpose of this study is to see if eating vitamin D, omega 3 and turmeric (curcumin) slows the growth of prostate cancer in men on active surveillance.

Detailed Description
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The primary objective is to investigate the influence of vitamin D, omega-3 fatty acids, and turmeric curcumin intake on the genomic landscape of NCCN very low and low risk patients managed with Active Surveillance. This will be measured by using genomic signatures in Decipher GRID and using the mixed effect linear model that tests for the interaction of treatment arm and time (base-line, 6 month and 12 month time points) with gene expression as the response variable. The secondary objective is to evaluate prostate cancer aggressiveness pre and post intervention by looking at genes and gene signatures associated with vitamin D and omega-3 fatty acids pathways. Prognostic performance of GRID gene signatures will be evaluated using Active Surveillance 'Failure' (deferred treatment) as an additional endpoint. The exploratory objective is to be able to use predictive genes and/or genomic signatures to assess benefit from vitamin D, omega-3 fatty acid and turmeric curcumin intake. This will only be possible once sufficient patient follow up is available.

Official Title
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Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Men Managed With Active Surveillance for Prostate Cancer

Conditions
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Prostate Cancer

Intervention / Treatment
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* Dietary Supplement: Vitamin D
* Dietary Supplement: Omega-3
* Dietary Supplement: Turmeric


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects must have the diagnosis of prostate cancer and be on active surveillance. For the purpose of this study, Active surveillance implies prostate-specific antigen (PSA)<10 ng/mL, biopsy Gleason sum </=6 with no pattern 4 or 5, cancer involvement of <33% of biopsy cores, and clinical stage T1/T2a tumor. Subjects must be followed at the Cleveland Clinic for active surveillance. Subjects must be willing to adhere to the dietary modification outlined in the protocol. Subjects must be willing to have prostate biopsies at the baseline, and six months after enrollment into the protocol Subjects must have the ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: Subjects receiving any treatment other than AS for prostate cancer. Subjects not followed by the Cleveland Clinic. Subjects unable to adhere to the dietary modification outlined in the protocol.
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
Interventional Model Description: Parallel groups, one with a control diet, the other with a modified diet
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Unmodified Diet<br>Patients are under active surveillance with no modification to their diet, as is standard of care for low risk prostate cancer | |
| Experimental: Diet modification<br>Patients receive Vitamin D, Omega-3 and turmeric curcumin as dietary supplements | Dietary Supplement: Vitamin D<br>* 5000 IU/cap; One cap by mouth daily<br>* Other names: Vitamin D3;Dietary Supplement: Omega-3<br>* 720 mg/cap; one capsule by mouth 3 times per day<br>* Other names: Omegagenics;Dietary Supplement: Turmeric<br>* 250mg/cap; two capsules by mouth 4 times per day<br>* Other names: Turmeric curcumin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gene expression of very low and low risk prostate cancer patients on Active Surveillance | The primary objective is to investigate the influence of vitamin D, omega-3 fatty acids, and turmeric curcumin intake on the genomic landscape of NCCN very low and low risk patients managed with Active Surveillance. This will be measured by using genomic signatures in Decipher GRID and using the mixed effect linear model that tests for the interaction of treatment arm and time | Up to 6 months | 
| gene expression of very low and low risk prostate cancer patients on Active Surveillance | The primary objective is to investigate the influence of vitamin D, omega-3 fatty acids, and turmeric curcumin intake on the genomic landscape of NCCN very low and low risk patients managed with Active Surveillance. This will be measured by using genomic signatures in Decipher GRID and using the mixed effect linear model that tests for the interaction of treatment arm and time | Up to 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Active Surveillance Failure | Cox proportional hazards model will be used to study if genes are significantly predictive of this outcome. P-values will be corrected for multiple testing using the Benjamini-Hochberg procedure. Genes will be considered significant if the corresponding p-value is below 0.05 using a two-sided test. | Up to 12 months | 
| Time to Active Surveillance Failure | Time to event will be defined as time from enrollment into the study. P-values will be corrected for multiple testing using the Benjamini-Hochberg procedure. | Up to 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Active Surveillance, Vitamin D, Omega-3 Fatty Acid, tumeric curcumin