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

NCT06865768 · Emory University
In plain English

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Official 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
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.
Eligibility criteria
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 target: 90 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2025-04-18
Estimated completion: 2029-12-31
Last updated: 2025-06-24
Interventions
Drug: Flotufolastat F-18 GalliumProcedure: Magnetic Resonance ImagingProcedure: Multiparametric Magnetic Resonance ImagingProcedure: Positron Emission TomographyProcedure: Transrectal Ultrasonography Guided Biopsy
Primary outcomes
  • Discrimination of clinically significant prostate cancer (csPCa) from non-csPCa (Up to 3 months from imaging scan)
Sponsor
Emory University · other
With: National Cancer Institute (NCI), National Institutes of Health (NIH)
Contacts & investigators
ContactDavid M. Schuster, MD, FACR · contact · dschust@emory.edu · 404-712-4859
InvestigatorDavid M Schuster, MD, FACR · principal_investigator, Emory University Hospital/Winship Cancer Institute
All locations (1)
Emory University HospitalRecruiting
Atlanta, Georgia, United States
An Investigational Scan (18F-rhPSMA-7.3 PET-mpMRI) for Targeted Prostate Biopsy Using TRUS-MR Fusion Technique · TrialPath