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 @ 7:02 PM
Ignite Modification Date:
2025-12-24 @ 7:02 PM
NCT ID:
NCT04976257
Eligibility Criteria:
Inclusion Criteria:
* Age greater than or equal to 18 years and less than or equal to 80 years.
* Children are excluded from this study because the disease does not occur in children
* Individuals from age 76 to age 80 must have a prior CT of the abdomen and pelvis within 5 years of first PSMA scan demonstrating non-occlusive pelvic atherosclerosis, regardless of smoking status
* Individuals over the age of 80 are excluded from this study to improve the likelihood of a catheterizable prostatic artery, given the higher rates of occlusive atherosclerosis with advanced age
* Ability to provide informed consent
* Biopsy-proven unilateral or bilateral prostate adenocarcinoma, any stage (any N or any M)
* Large tumor burden, characterized by either
* A discrete lesion with maximal tumor diameter \>= 2.0cm on at least one affected side, documented on prostate magnetic resonance imaging (MRI) or Transrectal ultrasound (TRUS) within 4 months of first scan.
* Infiltrative disease with primary pattern Gleason 4 adenocarcinoma in at least 4 of 6 sextant core biopsy locations on at least one affected side, documented in a surgical pathology report within 4 months of first scan.
* Gleason score \>= 4+4
* Cancer of the Prostate Risk Assessment (CAPRA) score \>= 6
Exclusion Criteria:
* Body mass index (BMI) \> 35 kg/m\^2
* Prior treatment for prostate cancer, or any use of anti-androgen therapy within 3 months of first scan
* History of any pelvic radiotherapy
* Severe atherosclerosis from prior CT imaging study, or greater than 10 pack-year smoking history if no prior imaging available.
* Stage IV or V chronic kidney disease by estimated glomerular filtration rate (eGFR) within 45 days of first scan
* Platelet count \< 50 x 10\^9/L and/or international normalized ratio \> 1.5
* Severe allergy to iodinated contrast
* Active urinary tract infection or recent episode of prostatitis within 1 month of first scan
* Inability to tolerate prolonged supine positioning
Healthy Volunteers:
False
Sex:
MALE
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT04976257
Study Brief:
Protocol Section:
NCT04976257