Status:
COMPLETED
Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer
Lead Sponsor:
Case Comprehensive Cancer Center
Conditions:
Prostate Cancer
Eligibility:
MALE
Phase:
NA
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 Activ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 7 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2019
Estimated Enrollment :
37 Patients enrolled
Trial Details
Trial ID
NCT03290417
Start Date
September 7 2017
End Date
December 20 2019
Last Update
February 18 2020
Active Locations (1)
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1
Cleveland Clinic, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195