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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-18

Study Completion Date

2029-12-31

Brief Summary

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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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Detailed Description

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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.

Conditions

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Prostate Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

MR interpreters will be blinded to PET findings

Study Groups

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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.

Group Type EXPERIMENTAL

Flotufolastat F-18 Gallium

Intervention Type DRUG

Given IV

Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo TRUS-MR fusion biopsy

Multiparametric Magnetic Resonance Imaging

Intervention Type PROCEDURE

Undergo mpMRI

Positron Emission Tomography

Intervention Type PROCEDURE

Undergo PET

Transrectal Ultrasonography Guided Biopsy

Intervention Type PROCEDURE

Undergo TRUS-MR fusion biopsy

Interventions

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Flotufolastat F-18 Gallium

Given IV

Intervention Type DRUG

Magnetic Resonance Imaging

Undergo TRUS-MR fusion biopsy

Intervention Type PROCEDURE

Multiparametric Magnetic Resonance Imaging

Undergo mpMRI

Intervention Type PROCEDURE

Positron Emission Tomography

Undergo PET

Intervention Type PROCEDURE

Transrectal Ultrasonography Guided Biopsy

Undergo TRUS-MR fusion biopsy

Intervention Type PROCEDURE

Other Intervention Names

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(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 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 MP-MRI mpMRI Multi-parametric MRI Multiparametric MRI Medical Imaging, Positron Emission Tomography PET PET Scan Positron emission tomography (procedure) Positron Emission Tomography Scan Positron-Emission Tomography PT TRUS Biopsy TRUS-Guided Biopsy

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Responsible Party

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David M Schuster

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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David M Schuster, MD, FACR

Role: PRINCIPAL_INVESTIGATOR

Emory University Hospital/Winship Cancer Institute

Locations

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Emory University Hospital

Atlanta, Georgia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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David M. Schuster, MD, FACR

Role: CONTACT

[email protected]

404-712-4859

Facility Contacts

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Khushali M. Vashi

Role: primary

[email protected]