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

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT06865768
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Flotufolastat F-18 Gallium — DRUG
    Given IV
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo TRUS-MR fusion biopsy
  • Multiparametric Magnetic Resonance Imaging — PROCEDURE
    Undergo mpMRI
  • Positron Emission Tomography — PROCEDURE
    Undergo PET
  • Transrectal Ultrasonography Guided Biopsy — PROCEDURE
    Undergo TRUS-MR fusion biopsy

Study Details

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.

Key Dates

Start date
Apr 18, 2025
Status verified
Jun 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2029

Study Design

Enrollment
90 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

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.

Primary Outcome Measure

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

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Emory University HospitalAtlantaGeorgia30322
Khushali M. Vashi
[email protected]
David M. Schuster, MD, FACR (PRINCIPAL_INVESTIGATOR)

Find similar trials in Atlanta, GA

By condition
Prostate cancer
By specialty
OncologyProstate oncologyMen's healthUrology
By research site
Emory University Hospital· Atlanta, GA

Related Studies