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

Case Comprehensive Cancer Center (Case CCC)

Status: Completed

Conditions: Prostate Cancer

Treatments: Dietary Supplement: Vitamin D; Dietary Supplement: Omega-3; Dietary Supplement: Turmeric

Study type: Interventional

Funder types: Other

Identifiers

NCT03290417

CASE3816

Details and patient eligibility

About

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.

Full 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.

Enrollment: 37 patients

Sex: Male

Volunteers: No 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.

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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37 participants in 2 patient groups

Unmodified Diet

No Intervention group

Description:

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

Diet modification

Experimental group

Description:

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

Treatment:

Dietary Supplement: Turmeric

Dietary Supplement: Omega-3

Dietary Supplement: Vitamin D