Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Jonsson Comprehensive Cancer Center
PRIMARY OBJECTIVE:
I. To assess the detection rate of clinically significant prostate cancer (Gleason score 7 or more) in patients with focal gallium Ga 68 gozetotide (68Ga-PSMA-11) uptake within the prostate.
OUTLINE:
SCREENING PROCEDURE: Patients receive 68Ga-PSMA-11 intravenously (IV) and 50-100 minutes later, undergo a PET/CT scan. Only patients with 68Ga-PSMA-11 uptake within the prostate proceed to image-guided biopsy.
IMAGE-GUIDED BIOPSY: Patients undergo experimental image-guided prostate biopsy using PET/CT images obtained during screening procedure during a standard of care transrectal ultrasonography guided biopsy (TRUS).
Age
18–90
Sex
MALE
Healthy volunteers
Not accepted
You may be eligible if
Men with suspicion of clinically significant prostate cancer with prior inconclusive, discordant or negative magnetic resonance imaging/ultrasound (MRI/US) fusion prostate biopsy
Scheduled for a repeat transrectal ultrasound (TRUS) prostate biopsy by standard of care
Focal 68Ga-PSMA-11 uptake within the prostate
You may not be if
Negative 68Ga-PSMA-11 uptake within the prostate (screening failure)
Age \< 18 and \> 90 years
Recurrent prostate cancer
Inability to provide written informed consent
Known inability to remain still and lie flat for the duration of the PET/CT (about 30 minutes)
Clareo Health | Image-Guided (68Ga-PSMA-11 PET/CT) Prostate Biopsy for the Diagnosis of Prostate Cancer in Men With Prior Negative/Inconclusive Biopsy
