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

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

383

Phase

  • 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 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

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
Intervention / Treatment
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

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

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

Clarity Pharmaceuticals Ltd

Investigators

  • 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)

December 21, 2023

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

September 21, 2023

First Submitted That Met QC Criteria

September 21, 2023

First Posted (Actual)

September 28, 2023

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 13, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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