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Correlative Analysis of the Genomics of Vitamin D and Omega-3 Fatty Acid Intake in Prostate Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03290417
Recruitment Status : Active, not recruiting
First Posted : September 21, 2017
Last Update Posted : July 16, 2019
Sponsor:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Dietary Supplement: Vitamin D Dietary Supplement: Omega-3 Dietary Supplement: Turmeric Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Completion Date : December 20, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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
Experimental: Diet modification
Patients receive Vitamin D, Omega-3 and turmeric curcumin as dietary supplements
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




Primary Outcome Measures :
  1. 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

  2. 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


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

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


Locations
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United States, Ohio
Cleveland Clinic, Case Comprehensive Cancer Center
Cleveland, Ohio, United States, 44195
Sponsors and Collaborators
Case Comprehensive Cancer Center
Investigators
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Principal Investigator: David Levy, MD Cleveland Clinic, Case Comprehensive Cancer Center

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Responsible Party: Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier: NCT03290417     History of Changes
Other Study ID Numbers: CASE3816
First Posted: September 21, 2017    Key Record Dates
Last Update Posted: July 16, 2019
Last Verified: July 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Case Comprehensive Cancer Center:
Active Surveillance
Vitamin D
Omega-3 Fatty Acid
tumeric curcumin
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Prostatic Diseases
Genital Diseases, Male
Vitamin D
Ergocalciferols
Vitamins
Curcumin
Turmeric extract
Micronutrients
Nutrients
Growth Substances
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
Antioxidants
Protective Agents