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

Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexMale
Age18+
SponsorEmory University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • Flotufolastat F-18 Gallium

    Drug

    Given IV

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo TRUS-MR fusion biopsy

  • Multiparametric Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo mpMRI

  • Positron Emission Tomography

    Procedure/Surgery

    Undergo PET

  • Transrectal Ultrasonography Guided Biopsy

    Procedure/Surgery

    Undergo TRUS-MR fusion biopsy

Treatment groups

90 Participants
are divided into 1 treatment group
Group A: Diagnostic (18F-rhPSMA-7.3 PET, mpMRI, TRUS-MR fusion biopsy)Experimental treatment 5 interventions

Trial outcomes

Primary outcomes

1

Discrimination of clinically significant prostate cancer (csPCa) from non-csPCa

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.

Time frame
Up to 3 months from imaging scan

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Emory University

Lead sponsor

National Cancer Institute (NCI)

Collaborator

National Institutes of Health (NIH)

Collaborator