ClinicalTrials.gg
CompletedNCT03290417Updated Feb 18, 2020

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

An interventional study of Vitamin D and Omega-3 in Prostate Cancer, sponsored by Case Comprehensive Cancer Center. Completed at 1 site in United States. Open to male participants. Per ClinicalTrials.gov, last updated 2020-02-18.

Sponsored by Case Comprehensive Cancer Center · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
37
Allocation
Randomized
Sex
Male
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 46 studies in Prostatic Neoplasms by Case Comprehensive Cancer Center — 8 open to participants now, 8 under way, none of them phase 3. Prostatic Neoplasms · Case Comprehensive Cancer Center.

Enrollment
16th of 42
37 · median 30
Started
2017
with 3 others
No phase
30 of 46
6 open now
Registered
28th of 46
by date

Among the 46 studies in Prostatic Neoplasms by Case Comprehensive Cancer Center, this one is the 16th largest by enrollment of the 42 interventional ones that give a count, is one of 4 that started in 2017, is one of 30 with no phase, and was the 28th registered.

Prostatic Neoplasms

7,046 studies on the registry are indexed under Prostatic Neoplasms; 1,580 are open to participants now.

Browse Prostatic Neoplasms studies →

Open to participants now

8 of the 46 studies in Prostatic Neoplasms by Case Comprehensive Cancer Center are open now, in 1 country. Recruiting first, the newest first:

3 more — sign in →

By country, each count listing its studies:

All 8 open studies →

Where they have run

Who these studies take

Of the 1,228 Prostatic Neoplasms studies recruiting now, 928 (76%) set no upper age limit and 76 (6%) stop at 75 or younger; 67 take children under 18; 82 take healthy volunteers.

This study: male · no healthy volunteers.

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02

Study 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.

Read the 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.

03

Conditions studied

  • Prostate Cancer

Browse trials for

Keywords

  • Active Surveillance
  • Vitamin D
  • Omega-3 Fatty Acid
  • tumeric curcumin
04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Male
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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, 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 document.

Exclusion criteria

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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Biopsy and archival tissue

A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.

Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
37 participants (actual)

Study arms

  • 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 · Dietary Supplement: Omega-3 · Dietary Supplement: Turmeric

Interventions

  • Dietary supplementVitamin D

    5000 IU/cap; One cap by mouth daily

    Also known as: Vitamin D3

  • Dietary supplementOmega-3

    720 mg/cap; one capsule by mouth 3 times per day

    Also known as: Omegagenics

  • Dietary supplementTurmeric

    Drug pages: Turmeric extract · Curcuma longa

    250mg/cap; two capsules by mouth 4 times per day

    Also known as: Turmeric curcumin

06

What researchers measure

Primary outcomes

  1. 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

    Time frame: Up to 6 months

  2. 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

    Time frame: Up to 12 months

Secondary outcomes

  1. 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.

    Time frame: Up to 12 months

  2. 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.

    Time frame: Up to 12 months

07

Study locations

1 site
  • Cleveland Clinic, Case Comprehensive Cancer Center
    Cleveland, Ohio 44195, United States
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2017 to primary completion in Jun 2019, 21 months.

Of 1,098 non-industry interventional studies with no phase under Prostatic Neoplasms, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 22 and three quarters within 86. This study's 21 months is below that.

Counting every sponsor, half of 1,155 studies reached it within 43 months; a quarter within 22 and three quarters within 84.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 19, 2017
First posted
Sep 21, 2017
StartActual
Sep 7, 2017
Primary completionActual
Jun 20, 2019
CompletionActual
Dec 20, 2019
Last update
Feb 18, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 18, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03290417
Responsible party
Sponsor
First posted
Sep 21, 2017
Start date
Sep 7, 2017
Primary completion
Jun 20, 2019
Completion
Dec 20, 2019
Last update
Feb 18, 2020

Study contacts

David Levy, MD
principal investigator · Cleveland Clinic, Case Comprehensive Cancer Center

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drugs tested here: Vitamin D · Omega-3 fatty acid

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