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

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Vitamin D
Omega-3
Turmeric
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prostate Cancer focused on measuring Active Surveillance, Vitamin D, Omega-3 Fatty Acid, tumeric curcumin

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)MaleDoes not accept 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.

Sites / Locations

  • Cleveland Clinic, Case Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Unmodified Diet

Diet modification

Arm Description

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

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

Outcomes

Primary Outcome Measures

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
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

Secondary Outcome Measures

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 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.

Full Information

First Posted
September 19, 2017
Last Updated
February 17, 2020
Sponsor
Case Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT03290417
Brief Title
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

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Completed
Study Start Date
September 7, 2017 (Actual)
Primary Completion Date
June 20, 2019 (Actual)
Study Completion Date
December 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Active Surveillance, Vitamin D, Omega-3 Fatty Acid, tumeric curcumin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Parallel groups, one with a control diet, the other with a modified diet
Masking
None (Open Label)
Allocation
Randomized
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Unmodified Diet
Arm Type
No Intervention
Arm Description
Patients are under active surveillance with no modification to their diet, as is standard of care for low risk prostate cancer
Arm Title
Diet modification
Arm Type
Experimental
Arm Description
Patients receive Vitamin D, Omega-3 and turmeric curcumin as dietary supplements
Intervention Type
Dietary Supplement
Intervention Name(s)
Vitamin D
Other Intervention Name(s)
Vitamin D3
Intervention Description
5000 IU/cap; One cap by mouth daily
Intervention Type
Dietary Supplement
Intervention Name(s)
Omega-3
Other Intervention Name(s)
Omegagenics
Intervention Description
720 mg/cap; one capsule by mouth 3 times per day
Intervention Type
Dietary Supplement
Intervention Name(s)
Turmeric
Other Intervention Name(s)
Turmeric curcumin
Intervention Description
250mg/cap; two capsules by mouth 4 times per day
Primary Outcome Measure Information:
Title
gene expression of very low and low risk prostate cancer patients on Active Surveillance
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
Time Frame
Up to 6 months
Title
gene expression of very low and low risk prostate cancer patients on Active Surveillance
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
Time Frame
Up to 12 months
Secondary Outcome Measure Information:
Title
Active Surveillance Failure
Description
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
Title
Time to Active Surveillance Failure
Description
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

10. Eligibility

Sex
Male
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Levy, MD
Organizational Affiliation
Cleveland Clinic, Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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