Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Sophia Kallas
CONTACT
Nikki Hubbard
CONTACT
Lead
Northwestern University
With
PRIMARY OBJECTIVE: I. Measure the rate of rhPSMA-7.3-PET-MRI identified Gleason Grade Group (GG) 3-5 disease on pathology or locally advanced disease. A threshold rate of 15% detection will be considered clinically significant. SEONDARY OBJECTIVE: I. Assessment of safety. EXPLORATORY OBJECTIVES: I. Determine the sensitivity, specificity, positive predictive value (PPV) and negative predictive value (NPV) for rhPSMA-PET-MRI to detect prostate cancer in the prostate stratified by Gleason Grade Groups. II. Correlate PET MRI findings with surgical specimens for those men who undergo surgical treatment (including assessment of pathological stage). III. Define whether gene expression of PSMA (FOLH1) as defined on the Decipher messenger ribonucleic acid (mRNA) expression platform relates to signal intensity on PSMA scan. IV. Determine whether Decipher genomic classifier scores, luminal / basal scores or androgen receptor activity scores relate to signal intensity on PSMA scans. OUTLINE: Patients receive rhPSMA-7.3 intravenously (IV) then undergo PET-MRI and mpMRI of the prostate on study. Patients also undergo Decipher test at screening and MRI-PET prostate biopsy or radical prostatectomy within 90 days per standard of care.
Age
18–any
Sex
MALE
Healthy volunteers
Accepted
