Recruiting
Phase 2

18F-rhPSMA-7.3

Sponsor:

Emory University

Code:

NCT06865768

Conditions

Prostate Carcinoma

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Flotufolastat F-18 Gallium

Magnetic Resonance Imaging

Multiparametric Magnetic Resonance Imaging

Positron Emission Tomography

Transrectal Ultrasonography Guided Biopsy

Study Details

Brief summary:

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.

Conditions

Prostate Carcinoma

Study ID

NCT06865768

Start date

Apr 18, 2025

Status verified date

Jul, 2026

Completion date

Dec 31, 2029

Anticipated

Primary completion date

Dec 31, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Male

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

90 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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.

Interventions

Flotufolastat F-18 Gallium

Given IV

Magnetic Resonance Imaging

Undergo TRUS-MR fusion biopsy

Multiparametric Magnetic Resonance Imaging

Undergo mpMRI

Positron Emission Tomography

Undergo PET

Transrectal Ultrasonography Guided Biopsy

Undergo TRUS-MR fusion biopsy

Primary outcome measure

  • Discrimination of clinically significant prostate cancer (csPCa) from non-csPCa [ Time Frame: Up to 3 months from imaging scan ]

Central Contacts and Locations

Central contacts

David M. Schuster, MD, FACR

404-712-4859dschust@emory.edu

Locations

Emory University Hospital

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

Khushali M. Vashi

khushali.vashi@emory.edu

Principal Investigator:

David M. Schuster, MD, FACR

More Information

Sponsor

Emory University

Last update posted

Jul 14, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2026-07-14.