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

July 13, 2026 updated by: David M Schuster, Emory University

Prospective Phase II Validation of the Performance of a Prostate-Specific Membrane Antigen (PSMA) Radiotracer for Positron Emission Tomography-Multiparametric Magnetic Resonance (PET-mpMR) Imaging to Target Prostate Biopsy Via Transrectal Ultrasound (TRUS) -Magnetic Resonance Imaging (MRI) Fusion Technique

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. To determine if simultaneous flotufolastat F-18 gallium (18F-rhPSMA-7.3) PET-mpMR improves the detection of clinically significant prostate cancer (csPCa) in Prostate Imaging-Reporting and Data System (PI-RADS) ≥ 3 lesions.

SECONDARY OBJECTIVE:

I. To explore associations between radiomics textural data from the PET acquisition, mpMR imaging, or both with the presence of csPCa.

OUTLINE:

Patients receive 18F-rhPSMA-7.3 intravenously (IV) and, 50 minutes later, undergo PET over 30 minutes at the time of standard of care (SOC) mpMRI. Patients may also undergo standard of care TRUS-MR fusion biopsy of targets identified on SOC mpMRI.

Study Type

Interventional

Enrollment (Estimated)

90

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: David M. Schuster, MD, FACR
  • Phone Number: 404-712-4859
  • Email: dschust@emory.edu

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University Hospital
        • Principal Investigator:
          • David M. Schuster, MD, FACR
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diagnostic (18F-rhPSMA-7.3 PET, mpMRI, TRUS-MR fusion biopsy)
Patients receive 18F-rhPSMA-7.3 IV and, 50 minutes later, undergo PET over 30 minutes at the time of SOC mpMRI. Patients may also undergo standard of care TRUS-MR fusion biopsy of targets identified on SOC mpMRI.
Procedure: Positron Emission Tomography
Undergo PET
Other Names:
  • Medical Imaging, Positron Emission Tomography
  • PET
  • PET Scan
  • Positron Emission Tomography Scan
  • Positron-Emission Tomography
  • PT
  • Positron emission tomography (procedure)
Procedure: Multiparametric Magnetic Resonance Imaging
Undergo mpMRI
Other Names:
  • Multiparametric MRI
  • MP-MRI
  • mpMRI
  • Multi-parametric MRI
Drug: Flotufolastat F-18 Gallium
Given IV
Other Names:
  • 18F-rhPSMA-7.3
  • rhPSMA-7.3 (18F)
  • (18F)-rhPSMA-7.3
  • 18FrhPSMA-7.3
  • F-18-rhPSMA-7.3
  • Fluorine-18 rhPSMA-7.3
  • Fluorine F 18 rhPSMA-7.3
  • Fluorine F 18 Radiohybrid PSMA-7.3
  • Posluma
Procedure: Magnetic Resonance Imaging
Undergo TRUS-MR fusion biopsy
Other Names:
  • MRI
  • Magnetic Resonance
  • Magnetic Resonance Imaging Scan
  • Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance
  • MR
  • MR Imaging
  • MRI Scan
  • NMR Imaging
  • NMRI
  • Nuclear Magnetic Resonance Imaging
  • Magnetic Resonance Imaging (MRI)
  • sMRI
  • Magnetic resonance imaging (procedure)
  • MRIs
  • Structural MRI
Procedure: Transrectal Ultrasonography Guided Biopsy
Undergo TRUS-MR fusion biopsy
Other Names:
  • TRUS Biopsy
  • TRUS-Guided Biopsy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 3 months from imaging scan

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Collaborators

National Cancer Institute (NCI)
National Institutes of Health (NIH)

Investigators

  • Principal Investigator: David M Schuster, MD, FACR, Emory University Hospital/Winship Cancer Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 18, 2025

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2029

Study Registration Dates

First Submitted

March 4, 2025

First Submitted That Met QC Criteria

March 4, 2025

First Posted (Actual)

March 10, 2025

Study Record Updates

Last Update Posted (Actual)

July 14, 2026

Last Update Submitted That Met QC Criteria

July 13, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00007915 (Other Identifier: Emory University Hospital/Winship Cancer Institute)
  • P30CA138292 (U.S. NIH Grant/Contract)
  • NCI-2025-00207 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
  • WINSHIP6265-24 (Other Identifier: Emory University Hospital/Winship Cancer Institute)
  • U01CA113913 (U.S. NIH Grant/Contract)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe