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

Sponsor

Case Comprehensive Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT03290417

Collaborator

(none)

Enrollment

Location

Arms

27.4

Actual Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer	Dietary Supplement: Vitamin D Dietary Supplement: Omega-3 Dietary Supplement: Turmeric	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

37 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Parallel groups, one with a control diet, the other with a modified dietParallel groups, one with a control diet, the other with a modified diet

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 7, 2017

Actual Primary Completion Date :

Jun 20, 2019

Actual Study Completion Date :

Dec 20, 2019

Arms and Interventions

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

Arm

Intervention/Treatment

No Intervention: Unmodified Diet

Patients are under active surveillance with no modification to their diet, as is standard of care for low risk prostate cancer

Experimental: Diet modification

Patients receive Vitamin D, Omega-3 and turmeric curcumin as dietary supplements

Dietary Supplement: Vitamin D

5000 IU/cap; One cap by mouth daily

Other Names:

Vitamin D3

Dietary Supplement: Omega-3

720 mg/cap; one capsule by mouth 3 times per day

Other Names:

Omegagenics

Dietary Supplement: Turmeric

250mg/cap; two capsules by mouth 4 times per day

Other Names:

Turmeric curcumin

Outcome Measures

Primary Outcome Measures

gene expression of very low and low risk prostate cancer patients on Active Surveillance [Up to 6 months]
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
gene expression of very low and low risk prostate cancer patients on Active Surveillance [Up to 12 months]
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

Secondary Outcome Measures

Active Surveillance Failure [Up to 12 months]
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.
Time to Active Surveillance Failure [Up to 12 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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.