Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 11:49 AM
Ignite Modification Date:
2025-12-26 @ 11:49 AM
NCT ID:
NCT03194516
Eligibility Criteria:
Inclusion Criteria:
* Male Adults ≥ 18 years of age
* New biopsy proven prostate adenocarcinoma meeting NCCN guidelines for active surveillance OR previously diagnosed prostate cancer patients on active surveillance
* Eastern Cancer Oncology Group performance status ≤2
* Life expectancy \> 1 year
* BMI ≥ 25 kg/m2
Exclusion Criteria:
* Diabetes mellitus on diabetes medication or insulin therapy
* Prior completion of MRI guided confirmation prostate biopsy
* Use of hormonal therapy including finasteride in the past 6 months
* Concomitant use of oral glucocorticosteroids
* Cholecystectomy within 1 year prior to study entry
* Symptoms requiring immediate surgical intervention or radiation therapy
* Active malignancy other than prostate cancer requiring therapy other than non-melanomatous skin cancers
* Participation in any clinical research study evaluating an investigational drug or therapy within one month prior to enrollment
* Any condition that in the judgment of the investigators would interfere with the subject's ability to comply with the study procedures, tolerate the dietary protocol or interfere with the evaluation of responses
* Unable or unwilling to provide informed consent
* Must not be a female of any age
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT03194516
Study Brief:
Protocol Section:
NCT03194516