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New PET-MRI tracer could sharpen prostate cancer biopsy accuracy

NCT ID NCT06865768

Diagnosis Sponsor: Emory University Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 14, 2026 · Last updated Jul 15, 2026 · Updated 1 time

Summary

This trial tests whether combining a radioactive tracer (18F-rhPSMA-7.3) with PET and multiparametric MRI can better identify clinically significant prostate cancer than MRI alone. Men suspected of having prostate cancer will receive the tracer and undergo imaging before a targeted biopsy. The goal is to see if the tracer's activity in suspicious areas improves the detection of aggressive tumors, potentially making biopsies more accurate.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a radioactive tracer called 18F-rhPSMA-7.3 (flotufolastat F-18) given intravenously, plus magnetic resonance imaging (MRI)
What this could lead to
If successful, this imaging method could help doctors more accurately identify aggressive prostate cancers during biopsy, reducing unnecessary procedures and improving treatment decisions.
What could go wrong
This is a phase II trial with only 90 participants, so results may not apply to all men. The technique may not significantly outperform standard MRI, and there are small risks from radiation exposure and MRI contraindications.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 90 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2025

Expected to finish

Dec 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

prostate cancer prostate carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Prostate carcinoma

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Emory University Hospital

    RECRUITING

    Atlanta, Georgia, 30322, United States

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