Clinical trial NCT03290417: Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Active Surveillance
Vitamin D
Omega-3 Fatty Acid
tumeric curcumin
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2017-09-21
Enrollment: 37
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel groups, one with a control diet, the other with a modified diet
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: gene expression of very low and low risk prostate cancer patients on Active Surveillance
timeFrame: Up to 6 months
measure: gene expression of very low and low risk prostate cancer patients on Active Surveillance
timeFrame: Up to 12 months
Secondary outcomes:
measure: Active Surveillance Failure
timeFrame: Up to 12 months
measure: Time to Active Surveillance Failure
timeFrame: Up to 12 months
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Cleveland Clinic, Case Comprehensive Cancer Center
name: David Levy, MD
role: PRINCIPAL_INVESTIGATOR
References: