NCT03290417 - Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer | Crick

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

37

Conditions

Prostate Cancer

Interventions

Vitamin DDIETARY_SUPPLEMENT

5000 IU/cap; One cap by mouth daily

Omega-3DIETARY_SUPPLEMENT

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

TurmericDIETARY_SUPPLEMENT

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

Eligibility

Sex: MALE

Medical Language ↔ Plain English

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.

Locations (1)

Cleveland Clinic, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: Up to 12 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: Up to 12 months