Actively Recruiting
Validation of a PSMA Radiotracer (18F-rhPSMA-7.3) PET-mpMRI to Target Prostate Biopsy Using TRUS-MR Fusion Imaging
Led by Emory University · Updated on 2025-06-24
90
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
E
Emory University
Lead Sponsor
N
National Cancer Institute (NCI)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating an imaging technique called 18F-rhPSMA-7.3 PET-multiparametric MRI (mpMRI) to better identify tumor tissue in men suspected of having prostate cancer. This phase II trial aims to improve detection of clinically significant prostate cancer in areas identified by the Prostate Imaging-Reporting and Data System (PI-RADS) score of 3 or higher. The study also explores how imaging data relates to tumor presence and characteristics during prostate biopsy. Participants receive an intravenous injection of 18F-rhPSMA-7.3 and, after 50 minutes, undergo a 30-minute PET scan alongside the standard mpMRI. Patients may then have a transrectal ultrasound-magnetic resonance imaging (TRUS-MR) fusion biopsy targeting suspicious areas seen on mpMRI. This combined imaging and biopsy approach is being assessed for its ability to more accurately find and confirm prostate tumors. During the study, men suspected of prostate cancer will have detailed imaging scans and possibly a biopsy. Researchers will evaluate how well the imaging detects clinically significant cancer within three months of the scans. The study involves monitoring imaging results, biopsy findings, and safety aspects related to the procedures. Participation includes consenting, imaging, and biopsy as needed, with follow-up assessments to determine diagnostic accuracy.
CONDITIONS
Brief Title
An Investigational Scan (18F-rhPSMA-7.3 PET-mpMRI) for Targeted Prostate Biopsy Using TRUS-MR Fusion Technique
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male subjects aged over 18 years
- Patients suspected of prostate cancer who are scheduled for prostate biopsy
- Ability to lie still during MRI scanning
- Ability to provide written informed consent
You will not qualify if you...
- Acute prostatitis, symptomatic or severe benign prostatic hyperplasia, or urinary tract infections
- Contraindications for MRI such as implantable pacemakers or cochlear implants
- Presence of uni- or bilateral hip prosthesis
- Significant medical conditions increasing biopsy risk or complicating study assessments
- Prostate biopsy within 4 weeks prior to study enrollment
- Clinical unsuitability as determined by the Investigator
- Inability to understand the language of the study information
- Participation in another clinical trial currently or within the past 30 days
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 1 day
Participants receive an intravenous injection of 18F-rhPSMA-7.3 followed by a PET scan and a multiparametric MRI to identify prostate lesions. Participants may also undergo a TRUS-MR fusion biopsy targeting lesions identified on MRI.
1 visit (in-person)
Duration - Up to 3 months
Participants are monitored for up to 3 months following the imaging scan to evaluate the detection of clinically significant prostate cancer.
Follow-up visits as needed
Trial Site Locations
Total: 1 location
1
Emory University Hospital
Atlanta, Georgia, United States, 30322
Actively Recruiting
Research Team
D
David M. Schuster, MD, FACR
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DIAGNOSTIC
Number of Arms
1
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