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 @ 11:10 AM
Ignite Modification Date:
2025-12-26 @ 11:10 AM
NCT ID:
NCT02237612
Eligibility Criteria:
Inclusion Criteria:
* Biopsy-documented adenocarcinoma of the prostate which is intermediate or high risk, defined as possessing one or more of the following features:
* Gleason \>= 7
* \> 50% biopsy cores +
* Prostate-specific antigen (PSA) \>= 10
* Interested in undergoing a radical prostatectomy as definitive management for prostate cancer
* No clinical or radiographic evidence for distant metastatic disease
* In subjects with PSA \< 20 no radiographic staging is required in the absence of clinical symptoms for distant metastatic disease; for those with PSA \> 20, a bone scan must document lack of concern for bone involvement
Exclusion Criteria:
* Ineligible for surgery due to cardiac, pulmonary, or other major comorbidity factor
* History of claustrophobia
* Pacemaker or other implanted metal objects which would make subject ineligible for MRI, per standard criteria
* Unable to give written informed consent
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT02237612
Study Brief:
Protocol Section:
NCT02237612