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NCT Number: NCT06865768

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

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Key information

Conditions

Prostate Carcinoma Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Phase 2

Primary location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location status: Recruiting

Location contact

David M. Schuster, MD, FACR

PRINCIPAL_INVESTIGATOR

Khushali M. Vashi

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Flotufolastat F-18 Gallium

Drug

Given IV

Other names: (18F)-rhPSMA-7.3, 18F-rhPSMA-7.3, 18FrhPSMA-7.3, F-18-rhPSMA-7.3, Fluorine F 18 Radiohybrid PSMA-7.3, Fluorine F 18 rhPSMA-7.3, Fluorine-18 rhPSMA-7.3, Posluma, rhPSMA-7.3 (18F)

Magnetic Resonance Imaging

Procedure

Undergo TRUS-MR fusion biopsy

Other names: Magnetic Resonance, Magnetic Resonance Imaging (MRI), Magnetic resonance imaging (procedure), Magnetic Resonance Imaging Scan, Medical Imaging, Magnetic Resonance / Nuclear Magnetic Resonance, MR, MR Imaging, MRI, MRI Scan, MRIs, NMR Imaging, NMRI, Nuclear Magnetic Resonance Imaging, sMRI, Structural MRI

Multiparametric Magnetic Resonance Imaging

Procedure

Undergo mpMRI

Other names: MP-MRI, mpMRI, Multi-parametric MRI, Multiparametric MRI

Positron Emission Tomography

Procedure

Undergo PET

Other names: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron emission tomography (procedure), Positron Emission Tomography Scan, Positron-Emission Tomography, PT

Transrectal Ultrasonography Guided Biopsy

Procedure

Undergo TRUS-MR fusion biopsy

Other names: TRUS Biopsy, TRUS-Guided Biopsy

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

David M. Schuster, MD, FACR

CONTACT

[email protected]

404-712-4859

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2028
Study completion
2029
First posted
Mar 10, 2025
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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