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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03290417
Other study ID # CASE3816
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 7, 2017
Est. completion date December 20, 2019

Study information

Verified date February 2020
Source Case Comprehensive Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 37
Est. completion date December 20, 2019
Est. primary completion date June 20, 2019
Accepts healthy volunteers No
Gender Male
Age group N/A and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Vitamin D
5000 IU/cap; One cap by mouth daily
Omega-3
720 mg/cap; one capsule by mouth 3 times per day
Turmeric
250mg/cap; two capsules by mouth 4 times per day

Locations

Country Name City State
United States Cleveland Clinic, Case Comprehensive Cancer Center Cleveland Ohio

Sponsors (1)

Lead Sponsor Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Up to 6 months
Primary 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 Up to 12 months
Secondary 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. Up to 12 months
Secondary 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. Up to 12 months
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