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Sharper eye for prostate cancer: new imaging agent aims to spot hidden spread

NCT ID NCT06056830

Diagnosis Sponsor: Clarity Pharmaceuticals Ltd 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

This phase 3 trial tests a new radioactive imaging agent, 64Cu-SAR-bisPSMA, to see if it can better detect prostate cancer that has spread to nearby lymph nodes. About 383 men with high-risk prostate cancer will receive a single injection of the agent before their scheduled prostate removal surgery. The goal is to compare the PET scan results with the actual findings from surgery to measure accuracy.

What this could mean

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

Active substance
64Cu-SAR-bisPSMA (a radioactive imaging agent)
What this could lead to
If successful, this could provide a more accurate way to detect prostate cancer spread before surgery, helping doctors plan better treatment.
What could go wrong
This is a diagnostic study, not a treatment. The imaging agent may not be more accurate than current methods, and there are small risks from radiation exposure.
Why investors are watching

Clarity Pharmaceuticals is running a phase 3 trial of its imaging agent 64Cu-SAR-bisPSMA to detect whether prostate cancer has spread to lymph nodes before surgery. For a small company, this readout is a key test of whether its product works well enough to support regulatory approval and future sales.

If it works: A positive result could support approval of the imaging agent, giving Clarity a commercial product in prostate cancer diagnosis. That would validate the company's technology and open a path to revenue.

If it fails: The trial could fail to show the agent accurately detects lymph node spread, which would delay or block approval. Trials often fail, and a negative result would hurt the company's prospects.

AI-written from the trial record. Speculative, and not investment advice.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 383 people

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

Started

Dec 2023

Expected to finish

Sep 2026

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

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: * At least 18 years of age. * Signed informed consent. * Untreated, histologically confirmed adenocarcinoma of the prostate. * High-risk or greater PC defined by National Comprehensive Cancer Network Guidelines Version 1.202327 (clinical stage ≥T3a, or Grade Group ≥4, or PSA \>20 ng/mL). * Patients electing to undergo RP with PLND. Exclusion Criteria: * Administration of any high energy (\>300 KeV) gamma-emitting radioisotope within 5 physical half-lives prior to Day 1. * Known or expected hypersensitivity to 64Cu-SAR-bisPSMA or any of its components. * Patients with known predominant small cell or neuroendocrine PC.

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Conditions

The condition(s) this trial relates to.

prostate cancer prostate neoplasm

As listed by the trial registrant

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

Prostate cancer Prostatic neoplasms

How to take part

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

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    34 sites in 3 countries. The list below names each one and where it is.

  3. 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 ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Albany Medical College, Department of Urology

    RECRUITING

    Albany, New York, 12208, United States

    Contact Email: •••••@•••••

  • Arkansas Urology Research Center, LLC

    RECRUITING

    Little Rock, Arkansas, 72211, United States

    Contact Email: •••••@•••••

    Contact Email: •••••@•••••

  • BAMF Health

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

    Contact Email: •••••@•••••

  • Biogenix Molecular, LLC

    RECRUITING

    Miami, Florida, 33165, United States

  • Carolina Urologic Research Center

    RECRUITING

    Myrtle Beach, South Carolina, 29572, United States

  • Corewell Health

    RECRUITING

    Grand Rapids, Michigan, 49503, United States

  • Duke University Medical Center

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Fiona Stanley Hospital

    RECRUITING

    Murdoch, Western Australia, 6150, Australia

  • Greater Los Angeles VA Medical Center

    RECRUITING

    Los Angeles, California, 90073, United States

  • Indiana University School of Medicine

    RECRUITING

    Indianapolis, Indiana, 46202, United States

  • Intermountain Health

    RECRUITING

    Murray, Utah, 84107, United States

  • Mayo Clinic- Jacksonville

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Mayo Clinic- Phoenix

    RECRUITING

    Phoenix, Arizona, 85054, United States

  • Mayo Clinic- Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Mount Sinai Doctors Urology Faculty Practice

    RECRUITING

    New York, New York, 10029, United States

  • NorthShore University Health System, Glenbrook Hospital

    RECRUITING

    Glenview, Illinois, 60026, United States

  • Oregon Urology

    RECRUITING

    Springfield, Oregon, 97477, United States

  • Pan American Center for Oncology Trials, LLC - Ciudadela

    RECRUITING

    San Juan, 00918, Puerto Rico

  • Princess Alexandra Hospital

    RECRUITING

    Woolloongabba, Queensland, Australia

  • RAMSAY HEALTH CARE AUSTRALIA PTY LIMITED (ABN 36 003 184 889) trading as Hollywood Private Hospital

    RECRUITING

    Nedlands, Western Australia, 6009, Australia

  • St. Vincent's Sydney

    RECRUITING

    Sydney, New South Wales, Australia

  • Stanford University Medical Center

    RECRUITING

    Stanford, California, 94305-5105, United States

  • The Urology Place

    RECRUITING

    San Antonio, Texas, 78240, United States

  • UC Irvine Health

    RECRUITING

    Orange, California, 92868, United States

    Contact Email: •••••@•••••

  • University of Alabama Birmingham Hospital

    RECRUITING

    Birmingham, Alabama, 35249-6830, United States

  • University of Texas Southwestern Medical Center

    RECRUITING

    Dallas, Texas, 75390-8896, United States

  • University of Wisconsin

    RECRUITING

    Madison, Wisconsin, 53705, United States

  • Urologic Specialists

    RECRUITING

    Tulsa, Oklahoma, 74146, United States

  • Urology Associates of Nashville

    RECRUITING

    Nashville, Tennessee, 37209, United States

  • Urology Austin, PLLC - Research Department

    RECRUITING

    Austin, Texas, 78759, United States

  • Urology Clinics of North Texas

    RECRUITING

    Dallas, Texas, 75231, United States

  • Urology Group of Southern California

    RECRUITING

    Los Angeles, California, 90017, United States

  • Wichita Urology Group

    RECRUITING

    Wichita, Kansas, 67226, United States

  • XCancer Omaha LLC

    RECRUITING

    Omaha, Nebraska, 68130, United States

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