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New scan could spot hidden aggressive prostate cancer in men who think They're safe

NCT ID NCT05852041

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 02, 2026 · Last updated Jul 02, 2026

Summary

This study tests whether a special PET-MRI scan using a radioactive tracer called rhPSMA-7.3 can find higher-risk prostate cancer that standard tests might miss. Men with low-risk or favorable intermediate-risk prostate cancer who are candidates for active surveillance will receive the scan before a prostate biopsy. The goal is to see if the scan better identifies those who actually need treatment rather than just monitoring.

What this could mean

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

Active substance
Flotufolastat F-18 Gallium (rhPSMA-7.3)
What this could lead to
If successful, this imaging method could help identify men who need immediate treatment rather than active surveillance, potentially catching aggressive prostate cancer earlier.
What could go wrong
This is a small early-phase pilot study, so results may not apply broadly. The radioactive tracer may not reliably distinguish aggressive from slow-growing cancers, and there are risks from radiation exposure and biopsy.

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

Early phase 1

The earliest testing in people: a first look at safety, in a very small group.

Participants

About 40 people

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

Started

Jun 2023

Expected to finish

Jun 2035

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

Accepted

You do not need to have the condition being studied to take part.

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: * Healthy men (Eastern Cooperative Oncology Group \[ECOG\] 0-1), \>= 18 years old with at least 10 year life expectancy * Histologically proven Gleason Grade Group 1 or 2 adenocarcinoma of the prostate * Last prostate cancer containing biopsy performed within 3-15 months (mo.) prior to screening. Biopsy must have been \>= 10 core biopsy and informed by prior mpMRI * Prostate cancer categorized as low risk or favorable risk by National Comprehensive Cancer Network (NCCN) criteria (low risk is defined as T1c-T2a, prostate-specific antigen \[PSA\] \< 10ng/ml, Gleason Grade Group 1 \[Gleason 3+3=6\] disease) and favorable intermediate risk as having no more than one of the following intermediate risk features, clinical T2b-T2c disease, PSA 10-20ng/ml, Gleason Grade Group 2 \[Gleason score 3+4=7\]) * Decipher genomic classifier score from prior biopsy \>= 0.45 * Institutional Review Board (IRB)-/Independent Ethics Committee (IEC)-approved written informed consent and privacy language as per national regulations must be obtained from the subject or legally authorized representative prior to any study-related procedures * Concurrent diseases and malignancies are permitted * Patients must have the ability to understand and the willingness to sign a written informed consent prior to registration on the study * Willing to undergo prostate biopsy prior to non-surgical treatment of prostate cancer and within 90 days of PET-MRI imaging Exclusion Criteria: * Prior radiotherapy, surgery, chemotherapy, or hormonal therapy for prostate cancer * NCCN very low risk category (T1c and Gleason Grade Group 1 \[Gleason score 3+3=6\], PSA \< 10 ng/mL, fewer than 3 prostate biopsy cores positive, =\< 50% cancer in any core, PSA density \< 0.15 ng/mL/g) * Decipher score \< 0.45 * Prior bladder outlet procedure (i.e,. holmium laser enucleation of the prostate \[HoLEP\], transurethral resection of the prostate \[TURP\], Urolift, Rezum) * Prohibited medications: use of 5 alpha reductase inhibitor or androgen deprivation therapy (i.e., leuprolide, relugolix) within 1 month of screening * Contra-indication or relative contra-indication to MRI (i.e., pacemaker) * History of hip replacement * Subject has received investigational therapy within 28 days or 5 half-lives, whichever is longer, prior to screening

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

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

  • Northwestern University

    RECRUITING

    Chicago, Illinois, 60611, United States

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