18F-rhPSMA-7.3 PET-mpMRI for Prostate Cancer

Recruiting in Palo Alto (17 mi)

Overseen byDavid M Schuster, MD, FACR

Age: 18+

Sex: Male

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Emory University

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of 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.

Research Team

David M Schuster, MD, FACR

Principal Investigator

Emory University Hospital/Winship Cancer Institute

Eligibility Criteria

This trial is for men suspected to have prostate cancer. It's evaluating a new imaging technique that may improve the accuracy of identifying tumor tissue in the prostate. Participants should be candidates for a biopsy and willing to undergo advanced imaging procedures.

Inclusion Criteria

Patients must be able to provide written informed consent

I am a man over 18 years old.

I am suspected to have prostate cancer and will undergo a biopsy.

See 1 more

Exclusion Criteria

Patients with contraindications for MRI including implantable pace makers, cochlear implants

Subjects with other significant medical conditions that would create unacceptable prostate biopsy risk, compromise retention on study or compromise study related assessments

Is determined by the Investigator that the patient is clinically unsuitable for the study

See 5 more

Treatment Details

Interventions

Flotufolastat F-18 Gallium (Cancer Imaging Agent)

Trial OverviewThe trial tests an investigational scan called 18F-rhPSMA-7.3 PET-mpMRI, which might better detect tumor tissue compared to standard mpMRI alone. The goal is to see if this new method can increase the precision of TRUS-MR fusion biopsies in locating abnormal prostate areas.

Participant Groups

1Treatment groups

Experimental Treatment

Group I: Diagnostic (18F-rhPSMA-7.3 PET, mpMRI, TRUS-MR fusion biopsy)Experimental Treatment5 Interventions

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.