NCT06865768 · Emory University
An Investigational Scan (18F-rhPSMA-7.3 PET-mpMRI) for Targeted Prostate Biopsy Using TRUS-MR Fusion Technique
What this study is about
This phase II trial evaluates an imaging technique called 18F-rhPSMA-7.3 positron emission tomography (PET)-multiparametric (mp) magnetic resonance imaging (MRI) in identifying tumor tissue in men suspected to have prostate cancer.
View original scientific description
This phase II trial evaluates an imaging technique called 18F-rhPSMA-7.3 positron emission tomography (PET)-multiparametric (mp) magnetic resonance imaging (MRI) in identifying tumor tissue in men suspected to have prostate cancer. This clinical trial also seeks to determine if the abnormal tissue identified during imaging represents the tumor tissue removed during transrectal ultrasound-magnetic resonance imaging (TRUS-MR) fusion biopsy of the prostate. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, 18F-rhPSMA-7.3. Because some tumors take up 18F-rhPSMA-7.3 it can be seen with PET. MRI uses radio waves and a powerful magnet linked to a computer to create detailed pictures of areas inside the body. These pictures can show the difference between normal and diseased tissue. Standard of care imaging for prostate cancer includes mpMRI, which is the combination of multiple magnetic resonance techniques, including diffusion weighted imaging, dynamic contrast-enhanced imaging, and spectroscopy, to achieve an image that will allow for better identification of tumor size and location, as well as possibly identifying tumor spread and aggressiveness. However, mpMRI may not be as effective in identifying prostate tumors that are clinically significant. A TRUS-MR biopsy involves using both ultrasound and MRI scans to locate abnormal areas in the prostate. An 18F-rhPSMA-7.3 PET-mpMRI may be more effective than mpMRI alone in identifying tumor tissue and may increase the accuracy of TRUS-MRI fusion biopsies in men suspected of having prostate cancer.
Interventions
DRUG
Flotufolastat F-18 Gallium
Given IV
PROCEDURE
Magnetic Resonance Imaging
Undergo TRUS-MR fusion biopsy
PROCEDURE
Multiparametric Magnetic Resonance Imaging
Undergo mpMRI
PROCEDURE
Positron Emission Tomography
Undergo PET
PROCEDURE
Transrectal Ultrasonography Guided Biopsy
Undergo TRUS-MR fusion biopsy
Primary outcome measures
Discrimination of clinically significant prostate cancer (csPCa) from non-csPCa
Time frame: Up to 3 months from imaging scan
Will determine if radiotracer activity within the sampled regions improves discrimination of csPCa from non-csPCa. The receiver operating characteristic and its associated area under the curve (AUC) for positron emission tomography standardized uptake value maximum will be estimated. To accommodate within-individual correlation among multiple lesions, 95% confidence intervals for the AUC will be obtained through bootstrap with re-sampling of patients.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Male subjects aged \> 18 years
- Patients with suspected prostate cancer who will have prostate biopsy for confirmation
- Ability to lie still for MRI scanning
- Patients must be able to provide written informed consent
Exclusion criteria
- Documented acute prostatitis, symptomatic or severe benign prostatic hyperplasia (BPH) or urinary tract infections
- Patients with contraindications for MRI including implantable pace makers, cochlear implants
- Patients with uni- or bilateral hip prosthesis
- Subjects with other significant medical conditions that would create unacceptable prostate biopsy risk, compromise retention on study or compromise study related assessments
- Prostate biopsy within 4 weeks prior to entry on this study in which inflammation might affect PET-mpMR result
- Is determined by the Investigator that the patient is clinically unsuitable for the study
- Is incapable of understanding the language in which the information for the patient is given
- Participation in a concurrent clinical trial or in another trial within the past 30 days
Where
- Atlanta, Georgia
Collaborators
National Cancer Institute (NCI), National Institutes of Health (NIH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 14, 2026 · Source of record for eligibility and locations