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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Unmodified Diet | No Intervention | Patients are under active surveillance with no modification to their diet, as is standard of care for low risk prostate cancer | |
| Diet modification | Experimental | Patients receive Vitamin D, Omega-3 and turmeric curcumin as dietary supplements |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin D | Dietary Supplement | 5000 IU/cap; One cap by mouth daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| David Levy, MD | Cleveland Clinic, Case Comprehensive Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic, Case Comprehensive Cancer Center | Cleveland | Ohio | 44195 | United States |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D014807 | Vitamin D |
| D002762 | Cholecalciferol |
| D004281 | Docosahexaenoic Acids |
| D003474 | Curcumin |
| ID | Term |
|---|---|
| D012632 | Secosteroids |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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Parallel groups, one with a control diet, the other with a modified diet
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| Omega-3 | Dietary Supplement | 720 mg/cap; one capsule by mouth 3 times per day |
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| Turmeric | Dietary Supplement | 250mg/cap; two capsules by mouth 4 times per day |
|
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| 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 |
| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D002782 |
| Cholestenes |
| D002776 | Cholestanes |
| D013261 | Sterols |
| D008563 | Membrane Lipids |
| D008055 | Lipids |
| D015525 | Fatty Acids, Omega-3 |
| D004042 | Dietary Fats, Unsaturated |
| D004041 | Dietary Fats |
| D005223 | Fats |
| D005231 | Fatty Acids, Unsaturated |
| D005227 | Fatty Acids |
| D005395 | Fish Oils |
| D009821 | Oils |
| D036381 | Diarylheptanoids |
| D006536 | Heptanes |
| D000473 | Alkanes |
| D006839 | Hydrocarbons, Acyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D002396 | Catechols |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |