Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Prostate Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 1/12/2019 |
| Start Date: | September 7, 2017 |
| End Date: | July 2019 |
Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Men Managed With Active Surveillance for Prostate Cancer
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.
slows the growth of prostate cancer in men 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 (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.
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.
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 <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.
We found this trial at
1
site
10201 Carnegie Avenue
Cleveland, Ohio 44195
Cleveland, Ohio 44195
Phone: 216-990-8011
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