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 @ 10:56 PM
Ignite Modification Date:
2025-12-24 @ 10:56 PM
NCT ID:
NCT04167969
Eligibility Criteria:
Inclusion Criteria:
Primary RP + PLND
* Age ≥18 years
* Patients meeting one of the following criteria:
* Tumor clinical stage T3a or higher
* Gleason score 8-10, or
* PSA level \> 20 ng/mL
* Patients deemed fit for surgery on the basis of preoperative evaluation at the physician's discretion
* Patient is scheduled for standard of care laparoscopic radical prostatectomy (with or without robotic assistance)
Salvage PLND
* Age ≥18 years
* Patients with presence of suspicious lymph node on CT or MRI (of a pelvic node =\> 10mm in short axis or a node with abnormal morphology such as roundness irregularity or loss of fatty hilum, or PSMA-avid on PSMA PET imaging
* Patients deemed fit for surgery on the basis of preoperative evaluation at the physician's discretion
* Patient is scheduled for standard of care salvage pelvic lymph node dissection (with or without robotic assistance)
Exclusion Criteria:
* Contraindications to standard-of-care MR imaging (e.g., metal implants, claustrophobia)
* Prior androgen-deprivation therapy for prostate cancer (N/A for Salvage PLND)
* Prior pelvic radiotherapy (N/A for Salvage PLND )
* Medical illness unrelated to the tumor that, in the opinion of the attending physician and principal investigator, will preclude administration of the tracer
°This includes patients with uncontrolled infection, chronic renal insufficiency (EGFR \< 60 mL/min/1.73m2), myocardial infarction within the past 6 months, unstable angina, cardiac arrhythmias other than chronic atrial fibrillation and chronic active or persistent hepatitis, or New York Heart Association Classification III or IV heart disease
* Weight greater than the 400-lb weight limit of the PET scanner
* Unmanageable claustrophobia
* Inability to lie in the scanner for 30 min
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Study:
NCT04167969
Study Brief:
Protocol Section:
NCT04167969