Prostate Cancer
Conditions
Keywords
Active Surveillance, Vitamin D, Omega-3 Fatty Acid, tumeric curcumin
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.
Interventions
DIETARY_SUPPLEMENTVitamin D
5000 IU/cap; One cap by mouth daily
DIETARY_SUPPLEMENTOmega-3
720 mg/cap; one capsule by mouth 3 times per day
DIETARY_SUPPLEMENTTurmeric
250mg/cap; two capsules by mouth 4 times per day
Sponsors
Case Comprehensive Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Parallel groups, one with a control diet, the other with a modified diet
Eligibility
Sex/Gender
MALE
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| gene expression of very low and low risk prostate cancer patients on Active Surveillance | Up to 6 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Active Surveillance Failure | Up to 12 months | 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 | Up to 12 months | 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. |
Countries
United States
Outcome results
None listed