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Investigating 18F-rhPSMA-7.3 PET-mpMRI for Prostate Cancer Biopsy

This study is looking at a new way to find prostate cancer using a special scan called 18F-rhPSMA-7.3 PET-mpMRI. This scan combines two imaging techniques (PET and MRI) to help doctors see prostate cancer more clearly. You would receive a small amount of a substance called Flotufolastat F-18 Gallium intravenously (into your vein) before the PET scan. The goal is to see if this combined scan can better identify important prostate cancer that needs treatment, compared to less serious forms. The study also wants to see if the areas that light up on the scan match the cancer found during a biopsy. You might be able to join if you are a man over 18, are suspected of having prostate cancer, and are scheduled for a prostate biopsy.

Study design
This is an interventional study planning to enroll 90 male participants. It is evaluating a new imaging technique for prostate cancer.
What's involved
You would receive Flotufolastat F-18 Gallium intravenously, then undergo PET and mpMRI scans. You may also have a standard TRUS-MR fusion biopsy.
Compensation
Not stated in the trial record.
Follow-up
The primary outcome for this study is measured up to 3 months from the imaging scan.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06865768

An Investigational Scan (18F-rhPSMA-7.3 PET-mpMRI) for Targeted Prostate Biopsy Using TRUS-MR Fusion Technique

Recruiting
PHASE2Ages 18+InterventionalDiagnostic
Emory University
~90 participants
Updated 2026-07-14 on ClinicalTrials.gov
What's tested:Flotufolastat F-18 GalliumMagnetic Resonance ImagingMultiparametric Magnetic Resonance ImagingPositron Emission TomographyTransrectal Ultrasonography Guided Biopsy

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Discrimination of clinically significant prostate cancer (csPCa) from non-csPCa
Measured over Up to 3 months from imaging scan

Conditions

Prostate Carcinoma

Explore related trials

Prostate Carcinoma

Where it's being run

1 sites across 1 states
Georgia1

Study leadership

  • David M Schuster, MD, FACR · PRINCIPAL_INVESTIGATOR · Emory University Hospital/Winship Cancer Institute

Who to contact

David M. Schuster, MD, FACR
[email protected]
404-712-4859
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

  • Discrimination of clinically significant prostate cancer (csPCa) from non-csPCaUp 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.