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 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 12:14 AM
NCT ID:
NCT02119858
Eligibility Criteria:
Inclusion Criteria:
* Stage 2, intermediate to high risk (per D'Amico criteria) localized prostate cancer with a prostate gland size =\< 100 grams
* Intermediate risk: prostate specific antigen (PSA) between 10-20, Gleason grade 7, or clinical stage T2b
* High risk: PSA \> 20 , Gleason grade \>= 8, or clinical stage \>= T2c
* Life expectancy of at least 10 years
* Eastern Cooperative Oncology Group (ECOG) performance status =\< 2
* The subject must be able to comply with the study procedures
* All subjects must have the ability to understand and the willingness to sign a written informed consent
Exclusion Criteria:
* Subject has significant liver disease, cirrhosis or liver insufficiency with abnormal liver function tests, as total bilirubin \> 1.5 x normal
* Subject has significant liver disease, cirrhosis or liver insufficiency with abnormal liver function tests, as serum glutamic oxaloacetic transaminase (SGOT) \> 2 x normal
* Prior prostate surgery (i.e. transurethral resection of the prostate), or any prior abdominal or pelvic surgery, most specifically for surgeries that may have included any form of lymphadenectomy or anatomic changes
* History of androgen deprivation therapy, any prior chemotherapy, or any prior radiation therapy to the pelvis
* Subject has a previous history of adverse reaction or allergy to ICG, iodine, shellfish or iodine dyes
* Subject in whom the use of x-ray dye or ICG is contraindicated including development of adverse events when previously or presently administered
* Subject has any medical condition, which in the judgment of the investigator and/or designee makes the subject a poor candidate for the investigational procedure
* The presence of medical conditions contraindicating general anesthesia or standard surgical approaches
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02119858
Study Brief:
Protocol Section:
NCT02119858