Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy (CLARIFY)

May 13, 2026 updated by: Clarity Pharmaceuticals Ltd

Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy: A Prospective, Single-arm, Multi-center, Blinded-review, Phase 3 Diagnostic Performance Study

The aim for this study is to assess the diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
383

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Australia
    • New South Wales
      • Sydney, New South Wales, Australia
        • Recruiting
        • St. Vincent's Sydney
        • Contact:
          • Louise Emmett, MD
    • Queensland
      • Woolloongabba, Queensland, Australia
        • Recruiting
        • Princess Alexandra Hospital
        • Contact:
          • Ian Vela, MD
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Recruiting
        • Fiona Stanley Hospital
        • Contact:
          • Dickon Hayne, MD
  • Puerto Rico
      • San Juan, Puerto Rico, 00918
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35249-6830
        • Recruiting
        • University of Alabama Birmingham Hospital
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jonathan E McConathy, MD, PhD
    • Arizona
      • Phoenix, Arizona, United States, 85054
        • Recruiting
        • Mayo Clinic- Phoenix
        • Contact:
          • Jack Andrews, MD
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
    • California
      • Los Angeles, California, United States, 90073
        • Recruiting
        • Greater Los Angeles VA Medical Center
        • Contact:
          • Gholam R. Berenji, MD
      • Los Angeles, California, United States, 90017
      • Orange, California, United States, 92868
        • Recruiting
        • UC Irvine Health
        • Contact:
        • Principal Investigator:
          • Edward Uchio, MD, FACS, CPI
      • Stanford, California, United States, 94305-5105
        • Recruiting
        • Stanford University Medical Center
        • Contact:
          • Hong Song, MD, PhD
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic- Jacksonville
        • Contact:
          • Ephraim Parent, MD
      • Miami, Florida, United States, 33165
        • Recruiting
        • Biogenix Molecular, LLC
        • Principal Investigator:
          • Serguei A Castaneda, MD
        • Contact:
    • Illinois
      • Glenview, Illinois, United States, 60026
        • Recruiting
        • NorthShore University Health System, Glenbrook Hospital
        • Contact:
          • Brian Helfand, MD
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana University School of Medicine
        • Contact:
        • Principal Investigator:
          • Clint D Bahler, MD
    • Kansas
      • Wichita, Kansas, United States, 67226
        • Recruiting
        • Wichita Urology Group
        • Principal Investigator:
          • Timothy Richardson, MD
    • Michigan
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic- Rochester
        • Contact:
          • Jeffrey Karnes, MD
    • Nebraska
      • Omaha, Nebraska, United States, 68130
        • Recruiting
        • XCancer Omaha LLC
        • Principal Investigator:
          • Luke Nordquist, MD
        • Contact:
    • New York
      • New York, New York, United States, 10029
        • Recruiting
        • Mount Sinai Doctors Urology Faculty Practice
        • Principal Investigator:
          • Ashutosh Tewari, MD
        • Contact:
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke University Medical Center
        • Contact:
        • Principal Investigator:
          • Terence Z Wong, MD, PhD, FACR
        • Principal Investigator:
          • Judd W Moul, MD, FACS
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74146
        • Recruiting
        • Urologic Specialists
        • Contact:
          • Shaun GS Grewal, MD
    • Oregon
      • Springfield, Oregon, United States, 97477
        • Recruiting
        • Oregon Urology
        • Contact:
          • Bryan Mehllhaff, MD
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Recruiting
        • Carolina Urologic Research Center
        • Principal Investigator:
          • Neal Shore, MD
    • Tennessee
      • Nashville, Tennessee, United States, 37209
        • Recruiting
        • Urology Associates of Nashville
        • Contact:
          • David Morris, MD
    • Texas
      • Dallas, Texas, United States, 75231
        • Recruiting
        • Urology Clinics of North Texas
        • Contact:
          • Alexander Parker, MD
      • Dallas, Texas, United States, 75390-8896
        • Recruiting
        • University of Texas Southwestern Medical Center
        • Contact:
        • Contact:
          • Radiology Clinical Research Office
      • San Antonio, Texas, United States, 78240
        • Recruiting
        • The Urology Place
        • Contact:
          • Naveen Kella, MD
    • Utah
      • Murray, Utah, United States, 84107
        • Recruiting
        • Intermountain Health
        • Contact:
          • Dustin L. Boothe, MD
    • Wisconsin
      • Madison, Wisconsin, United States, 53705
        • Recruiting
        • University of Wisconsin
        • Contact:
          • Nandakumar Menon, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 64Cu-SAR-bisPSMA
200MBq 64Cu-SAR-bisPSMA.
Drug: 64Cu-SAR-bisPSMA
All Patients will receive a single administration, a bolus injection of 200MBq 64Cu-SAR-bisPSMA.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases
Time Frame: Up to 16 weeks
Independent primary endpoints for Day 1 and Day 2 PET: Co-primary endpoint of sensitivity and specificity of 64Cu-SAR-bisPSMA PET to detect Prostate Cancer within the pelvic lymph nodes compared to the Standard of Truth.
Up to 16 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety and tolerability of 64Cu-SAR-bisPSMA
Time Frame: Up to 16 weeks
Incidence and severity of treatment-emergent AEs and SAEs following administration of 64Cu-SAR-bisPSMA
Up to 16 weeks
Consistency of 64Cu-SAR-bisPSMA PET/CT interpretations for the three central readers
Time Frame: Up to 16 weeks
Inter-reader reliability of agreement estimated with a multiple-reader kappa statistic
Up to 16 weeks
PPV and NPV of 64Cu-SAR-bisPSMA PET to detect PC within the pelvic LNs
Time Frame: Up to 16 weeks
PPV and NPV of 64Cu-SAR-bisPSMA PET to detect PC within the pelvic LNs compared to the Standard of Truth
Up to 16 weeks
Ability of 64Cu-SAR-bisPSMA PET to detect Prostate Cancer
Time Frame: Up to 16 weeks
Sensitivity of 64Cu-SAR-bisPSMA PET to detect PC within the prostate gland compared to the Standard of Truth
Up to 16 weeks
Diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases without subregion matching
Time Frame: Up to 16 weeks
Sensitivity and specificity of 64Cu-SAR-bisPSMA PET to detect PC within the pelvic LNs compared to the Standard of Truth, without the requirement of subregion (Left or Right) matching between 64Cu-SAR-bisPSMA PET and Standard of Truth
Up to 16 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Clarity Pharmaceuticals Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clarity Pharmaceuticals, Clarity Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 21, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 21, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 21, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 28, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CLP04

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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