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New scan could spot hidden prostate cancer early

NCT ID NCT06970847

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 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026

Summary

This phase 3 study tests a new type of PET scan (64Cu-SAR-bisPSMA) to see if it can better detect prostate cancer that has come back after initial treatment. The study involves 220 adults with a rising PSA level after surgery or radiation. The goal is to improve detection so doctors can plan the right treatment sooner.

Why investors are watching

Clarity Pharmaceuticals is running a phase 3 trial of its imaging agent, 64Cu-SAR-bisPSMA, to detect prostate cancer recurrence in 220 participants. For a small-cap company, this readout is a major test of whether its product can reliably find cancer that standard scans miss, which would validate its core technology and support regulatory approval.

If it works: A positive result could show that the imaging agent accurately detects recurrent prostate cancer, giving Clarity a clear path to seek approval and launch its first commercial product. That success could establish the company as a player in cancer imaging and attract partnerships or licensing deals.

If it fails: A failure or delay could set the company back years, since it has few other products in late-stage development. Trials often fail to meet their endpoints, and a negative readout could force the company to redesign the study or raise more money, which would strain its resources.

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 220 people

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

Started

May 2025

Expected to finish

Dec 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: 1. At least 18 years of age. 2. Signed informed consent. 3. Life expectancy ≥ 6 months as determined by the Investigator. 4. Histologically confirmed adenocarcinoma of prostate per original diagnosis and completed subsequent definitive therapy. 5. Participant potentially eligible for salvage therapy with curative intent (i.e. aligns with the definition of loco-regional therapy as described in protocol Section 7.2). 6. PSA level after definitive therapy: 1. Post-radical prostatectomy: Detectable or rising PSA that is ≥ 0.2 ng/mL with a confirmatory PSA ≥ 0.2 ng/mL (per AUA recommendation) or 2. Post-radiation therapy, cryotherapy, or brachytherapy: Increase in PSA level that is elevated by ≥ 2 ng/mL above the nadir (per ASTRO-Phoenix consensus definition). 7. Participant willing to undergo biopsy of a 64Cu-SAR-bisPSMA PET-positive lesion for histological confirmation of PC, where this is safe and feasible. 8. An Eastern Cooperative Oncology performance status of 0-2. Exclusion Criteria: 1. Participants who received investigational agent within 5 biological half-lives prior to Day 1. 2. Participants administered any high energy (\>300 KeV) gamma-emitting radioisotope within 5 physical half-lives prior to Day 1. 3. Participants with known predominant small cell or neuroendocrine PC. 4. Previous systemic therapy for PC (with the exception of neoadjuvant and adjuvant systemic therapy as part of the definitive therapy and/or salvage therapy with radiation). 5. Ongoing treatment or treatment within 6 months of Day 1 with any systemic therapy (e.g. any investigational therapy, androgen-deprivation therapy, antiandrogen, gonadotropin-releasing hormone, luteinizing hormone-releasing hormone agonist or antagonist, chemotherapy, immunotherapy or radiotherapy) for PC. 6. Participants for whom there is an intent to initiate a prohibited medication(s)/treatment(s) (refer to Section 7.3) during the course of the participant's involvement in the study. 7. Known or expected hypersensitivity to 64Cu-SAR-bisPSMA or any of its components. 8. Any serious medical condition or extenuating circumstance (including receiving the investigational product or not capable of having a PET scan) which the investigator feels may interfere with the procedures or evaluations of the study.

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Conditions

The condition(s) this trial relates to.

hormone-resistant prostate carcinoma prostate cancer

As listed by the trial registrant

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

Cryotherapy Prostate cancer Prostate cancer patients treated by radiotherapy Prostate cancer patients who have brachytherapy seed implant Prostate cancer patients with detectable PSA following prostatectomy Prostate cancer recurrent

Contacts and locations

Locations

  • Alarcon Urology Center

    Montebello, California, 90640, United States

  • Albany Medical College

    Albany, New York, 12208, United States

  • Biogenix Molecular

    Miami, Florida, 33165, United States

  • Carolina Urologic Research Center

    Myrtle Beach, South Carolina, 29572, United States

  • Comprehensive Urology Medical Group

    Los Angeles, California, 90048, United States

  • Endeavor Health- Glenbrook Hospital

    Glenview, Illinois, 60201, United States

  • Indiana University Health-IU Simon Cancer Center

    Indianapolis, Indiana, 46202, United States

  • Intermountain Medical Center

    Salt Lake City, Utah, 84111, United States

  • M. Health Fairview University of Minnesota Medical Center

    Minneapolis, Minnesota, 55455, United States

  • Royal Brisbane and Women's Hospital

    Herston, Queensland, 4029, Australia

  • St. Louis University

    St Louis, Missouri, 63103, United States

  • St. Vincent's Hospital, Sydney

    Darlinghurst, New South Wales, 2010, Australia

  • Summit Urology

    Murray, Utah, 84107, United States

  • Sydney Adventist Hospital

    Wahroonga, New South Wales, 2076, Australia

  • The Urology Place

    San Antonio, Texas, 78240, United States

  • UC Irvine

    Irvine, California, 92697, United States

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania, 15260, United States

  • Urology Associates, P.C.

    Nashville, Tennessee, 37209, United States

  • Urology Clinics of North Texas

    Dallas, Texas, 75231, United States

  • Westmead Private Hosptial

    Westmead, New South Wales, 2145, Australia

  • XCancer

    Omaha, Nebraska, 68130, United States

  • XCancer Research Network / LCMC Health EJGH

    Metairie, Louisiana, 700006, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.