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:
2025-12-25 @ 2:11 AM
Ignite Modification Date:
2025-12-25 @ 2:11 AM
NCT ID:
NCT03397160
Eligibility Criteria:
Inclusion Criteria:
* Male \>=18 years of age and newly diagnosed prostate cancer (PCa) (within 3-months).
* Documentation of a low-risk PCa diagnosis as evidenced by clinical features of the following criteria:
* PSA test at diagnosis \<=15 ng/ml
* Localized PCa (cT1/T2,N0,M0)
* Biopsy Gleason grade 2-6 OR (or 3+4 AND \<=33% cores are positive for adenocarcinoma)
\*\*\*A minimum of 10 diagnostic cores taken by a systematic directed approach. Sampling may be obtained by target transrectal ultrasound (TRUS) or MRI imaging.
* No treatment yet
* No previous radiation or simultaneous use of androgen deprivation
* Prior use of 5-alpha reductase inhibitor is allowed if they have been stopped for 6 or more months and biopsy performed when patient was not taking the drug
* English language proficient and ability to provide informed consent
* Managing urologist considers them a candidate for active surveillance
* Written informed consent (and assent when applicable) obtained from subject and ability for subject to comply with the requirements of the study, including the ability to read and speak English.
Exclusion Criteria:
* Participants will be ineligible if they:
1. have pursued any active therapy for prostate cancer will be excluded;
2. are unable to read/speak English; or
3. if their managing urologist does NOT deem them as a candidate for active surveillance.
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT03397160
Study Brief:
Protocol Section:
NCT03397160