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New PET scan could spot hidden aggressive prostate cancer in men avoiding treatment

NCT ID NCT07285057

Diagnosis Sponsor: Icahn School of Medicine at Mount Sinai 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing whether adding a special PET scan (using a radioactive tracer called flotufolastat F18) to the standard MRI can better find aggressive prostate cancer in men who are currently on active surveillance. About 120 men with low- or favorable intermediate-risk prostate cancer will get both scans before a confirmatory biopsy. The goal is to see if the PET scan catches cancers that MRI misses, helping doctors decide who truly needs treatment.

What this could mean

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

Active substance
Flotufolastat F18 (POSLUMA®), a radioactive tracer used in PET/CT imaging
What this could lead to
If successful, this could lead to a more accurate imaging method to detect aggressive prostate cancer early, helping men on active surveillance avoid unnecessary biopsies or delayed treatment.
What could go wrong
This is a small, early-phase study (120 participants) at a single center. The imaging agent is already FDA-approved, but its added benefit over standard MRI is unproven, and results may not apply to all patients.

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 120 people

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

Started

Feb 2026

Expected to finish

May 2027

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 participants aged ≥18 years. * Histologically confirmed diagnosis of prostate adenocarcinoma. * Classified as low-risk or favorable intermediate-risk prostate cancer according to NCCN criteria: Low-risk: Grade Group 1, PSA \<10 ng/mL, cT1-T2a Favorable intermediate-risk: Grade Group 2, PSA 10-20 ng/mL, cT2b-c Currently managed with active surveillance. * Able and willing to undergo rhPSMA-7.3 (¹⁸F) PET/CT imaging, mpMRI, and confirmatory prostate biopsy. * Able to provide written informed consent. Exclusion Criteria: * A history of other active malignancy within the last 5 years, except for non-melanoma skin cancer. * Contraindication to 3-T mpMRI. * Significant intercurrent morbidity\*\* limiting compliance with study protocols. \*\* Significant intercurrent morbidity refers to a substantial medical condition or complication that arises during a study or treatment, which is severe enough to impact the patient's participation, treatment outcomes, or overall prognosis. These conditions may be unrelated to the primary disease but can influence clinical decision-making, treatment efficacy, and patient safety. Examples include major infections, cardiovascular events, organ failure, or significant worsening of pre-existing comorbidities (https://doi.org/10.1016/S1053-4296(03)00031-6). * History of allergic reactions attributed to compounds of similar chemical or biologic composition to Agent(s) or other agents used in study.

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Conditions

The condition(s) this trial relates to.

prostate adenocarcinoma prostate cancer prostate neoplasm

As listed by the trial registrant

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

Prostate adenocarcinoma Prostate cancer Prostatic neoplasms

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

  • Mount Sinai Hospital / Icahn School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10029, United States

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