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:
2025-12-24 @ 8:02 PM
Ignite Modification Date:
2025-12-24 @ 8:02 PM
NCT ID:
NCT01300104
Eligibility Criteria:
Inclusion Criteria:
* Biopsy proven prostate cancer within 2 years prior to enrolment
* PSA ≤ 10 ng/ml, Gleason-score ≤ 6, clinical localized prostate cancer ≤ cT2a or PSA ≤ 10 ng/ml, Gleason-score ≤ 7, clinical localized prostate cancer ≤ cT2a.
* Maximum 1/5 tumor positive biopsy rate
* On active surveillance (elected to forgo treatment)
* Level of testosterone normal in sera
Exclusion Criteria:
* Prior history of cancer, except for non-melanoma skin cancer, unless considered cured without signs of treatment failure for at least five years
* Less than 10 years of life expectancy
* Conditions or behaviors likely to affect the capability of participating fully in the intervention
* Moderate to severe co-morbidity (kidney, liver, heart or respiratory problems) or the general physical constitution
* Gluten intolerance
* Inflammatory bowel disease (e.g. Crohn, colitis)
* Physical handicaps
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
55 Years
Maximum Age:
70 Years
Study:
NCT01300104
Study Brief:
Protocol Section:
NCT01300104