Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer
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| ClinicalTrials.gov Identifier: NCT03290417 |
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Recruitment Status :
Completed
First Posted : September 21, 2017
Last Update Posted : February 18, 2020
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Prostate Cancer | Dietary Supplement: Vitamin D Dietary Supplement: Omega-3 Dietary Supplement: Turmeric | Not Applicable |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 37 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Intervention Model Description: | Parallel groups, one with a control diet, the other with a modified diet |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Men Managed With Active Surveillance for Prostate Cancer |
| Actual Study Start Date : | September 7, 2017 |
| Actual Primary Completion Date : | June 20, 2019 |
| Actual Study Completion Date : | December 20, 2019 |
| Arm | Intervention/treatment |
|---|---|
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No Intervention: Unmodified Diet
Patients are under active surveillance with no modification to their diet, as is standard of care for low risk prostate cancer
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Experimental: Diet modification
Patients receive Vitamin D, Omega-3 and turmeric curcumin as dietary supplements
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Dietary Supplement: Vitamin D
5000 IU/cap; One cap by mouth daily
Other Name: Vitamin D3 Dietary Supplement: Omega-3 720 mg/cap; one capsule by mouth 3 times per day
Other Name: Omegagenics Dietary Supplement: Turmeric 250mg/cap; two capsules by mouth 4 times per day
Other Name: Turmeric curcumin |
- gene expression of very low and low risk prostate cancer patients on Active Surveillance [ Time Frame: 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
- gene expression of very low and low risk prostate cancer patients on Active Surveillance [ Time Frame: Up to 12 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
- Active Surveillance Failure [ Time Frame: 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 [ Time Frame: 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.
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | Male |
| Accepts 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03290417
| United States, Ohio | |
| Cleveland Clinic, Case Comprehensive Cancer Center | |
| Cleveland, Ohio, United States, 44195 | |
| Principal Investigator: | David Levy, MD | Cleveland Clinic, Case Comprehensive Cancer Center |
| Responsible Party: | Case Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT03290417 |
| Other Study ID Numbers: |
CASE3816 |
| First Posted: | September 21, 2017 Key Record Dates |
| Last Update Posted: | February 18, 2020 |
| Last Verified: | February 2020 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Active Surveillance Vitamin D Omega-3 Fatty Acid tumeric curcumin |
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Prostatic Neoplasms Genital Neoplasms, Male Urogenital Neoplasms Neoplasms by Site Neoplasms Prostatic Diseases Genital Diseases, Male Genital Diseases Urogenital Diseases Male Urogenital Diseases Vitamin D Ergocalciferols Cholecalciferol Vitamins Curcumin |
Turmeric extract Micronutrients Physiological Effects of Drugs Bone Density Conservation Agents Calcium-Regulating Hormones and Agents Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Anti-Inflammatory Agents Antirheumatic Agents Antineoplastic Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |