Brief Summary

This early phase I trial evaluates whether a new imaging technique using flotufolastat F 18 (a type of prostate specific membrane antigen \[PSMA\] imaging agent) with positron emission tomography (PET)/computed tomography (CT) can be used to guide targeted prostate biopsies in men with prostate cancer. Flotufolastat F 18 is a radioactive imaging agent that binds to prostate tumor cells that express PSMA. This allows for visualization of PSMA-expressing tumor cells on imaging scans such as PET/CT. 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, flotufolastat F 18. Because prostate cancer takes up flotufolastat F 18, it can be seen with PET. CT utilizes X-rays that track the body from the outside. CT images provide an exact outline of organs and potential inflammatory tissue where it occurs in the body. The PET/CT scanner combines the PET and the CT scanners into a single device. A targeted prostate biopsy refers to using advanced imaging for guidance when taking samples (biopsies) of the prostate. This method can fuse (combine) PET/CT images with real-time ultrasound during a prostate biopsy. PSMA PET/CT scans have the potential for guiding prostate biopsies. Using image fusion technology, they can increase detection of prostate cancer by providing anatomical information and guidance during a prostate biopsy. Improved detection of prostate cancer using PSMA PET/CT guidance may better inform men and their clinicians about prostate cancer risk and management. This study attempts to determine how often prostate cancer is found when using PSMA PET/CT scan images during a biopsy versus the conventional magnetic resonance imaging-guidance.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

participants targeted

Target at P50-P75 for early_phase_1

Timeline

130mo left

Started Nov 2025

Longer than P75 for early_phase_1

Geographic Reach

1 country

1 active site

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

11.2 years study duration

Study Progress4%

Nov 2025Jan 2037

First Submitted

Initial submission to the registry

August 25, 2025

Completed

15 days until next milestone

First Posted

Study publicly available on registry

September 9, 2025

Completed

2 months until next milestone

Study Start

First participant enrolled

November 14, 2025

Completed

10.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2036

Expected

1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2037

Last Updated

March 10, 2026

Status Verified

March 1, 2026

Enrollment Period

10.2 years

First QC Date

August 25, 2025

Last Update Submit

March 6, 2026

Conditions

Prostate Carcinoma

Outcome Measures

Primary Outcomes (1)

Detection of high-grade cancer (grade group [GG] ≥ 2)
Results of prostate specific membrane antigen (PSMA)- and magnetic resonance imaging (MRI)-guided biopsy will be compared to the results of systematic biopsy in the same patient.
At time of biopsy

Secondary Outcomes (4)

Proportion of subjects with incidental GG1 prostate cancer detected through systematic biopsy when the region of interest is benign on MRI and PSMA-positron emission tomography (PET)
At time of biopsy
Rate of detection of GG ≥ 2 prostate cancer in relation to increasing standardized uptake value and Prostate Imaging-Reporting and Data System scores
At time of biopsy
Percentage of cases where the intraprostatic tumor location identified by MRI-guided and PSMA-guided biopsies matches
At time of biopsy
Accuracy and predictive value of the MRI + PSMA-PET composite score for detecting clinically significant prostate cancer during biopsy
At time of biopsy

Study Arms (1)

Diagnostic (flotufolastat F-18 PET/CT)

EXPERIMENTAL

Patients receive flotufolastat F-18 IV and then, 50-100 minutes later, undergo PET/CT over 30 minutes. Within 6 months of PET/CT imaging, patients undergo PSMA PET/CT/US fusion biopsy and MRI/US fusion biopsy in a randomized order. Patients may undergo blood sample collection at screening and/or on study.

Procedure: Biopsy of ProstateProcedure: Biospecimen CollectionProcedure: Computed TomographyRadiation: Flotufolastat F-18 GalliumProcedure: Positron Emission Tomography