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

Not Applicable

Completed

• Conditions: Prostate Cancer
• Interventions: Dietary Supplement: Vitamin D; Dietary Supplement: Omega-3; Dietary Supplement: Turmeric

• Registration Number: NCT03290417
• Lead Sponsor: Case Comprehensive Cancer Center

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.

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 Timeline

• Study Start: 2017-09-07
• Study First Submitted: 2017-09-19
• Study First Submitted QC: 2017-09-19
• Study First Posted: 2017-09-21
• Primary Completion: 2019-06-20
• Study Completion: 2019-12-20
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-17
• Last Update Posted: 2020-02-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 37

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Diet modification	Omega-3	Patients receive Vitamin D, Omega-3 and turmeric curcumin as dietary supplements
Diet modification	Vitamin D	Patients receive Vitamin D, Omega-3 and turmeric curcumin as dietary supplements
Diet modification	Turmeric	Patients receive Vitamin D, Omega-3 and turmeric curcumin as dietary supplements

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.
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.

Trial Locations

Locations (1)

Cleveland Clinic, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States