Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy
NCT ID: NCT06056830
Last Updated: 2025-12-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
383 participants
INTERVENTIONAL
2023-12-21
2026-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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64Cu-SAR-bisPSMA
200MBq 64Cu-SAR-bisPSMA.
64Cu-SAR-bisPSMA
All Patients will receive a single administration, a bolus injection of 200MBq 64Cu-SAR-bisPSMA.
Interventions
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64Cu-SAR-bisPSMA
All Patients will receive a single administration, a bolus injection of 200MBq 64Cu-SAR-bisPSMA.
Eligibility Criteria
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Inclusion Criteria
* 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
* Known or expected hypersensitivity to 64Cu-SAR-bisPSMA or any of its components.
* Patients with known predominant small cell or neuroendocrine PC.
18 Years
MALE
No
Sponsors
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Clarity Pharmaceuticals Ltd
INDUSTRY
Responsible Party
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Principal Investigators
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Clarity Pharmaceuticals
Role: STUDY_DIRECTOR
Clarity Pharmaceuticals
Locations
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Mayo Clinic- Phoenix
Phoenix, Arizona, United States
Greater Los Angeles VA Medical Center
Los Angeles, California, United States
Stanford University Medical Center
Stanford, California, United States
Mayo Clinic- Jacksonville
Jacksonville, Florida, United States
NorthShore University Health System
Glenview, Illinois, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
BAMF Health
Grand Rapids, Michigan, United States
Corewell Health
Grand Rapids, Michigan, United States
Mayo Clinic- Rochester
Rochester, Minnesota, United States
XCancer Omaha LLC
Omaha, Nebraska, United States
Mount Sinai Doctors Urology Faculty Practice
New York, New York, United States
Urologic Specialists
Tulsa, Oklahoma, United States
Oregon Urology
Springfield, Oregon, United States
Carolina Urologic Research Center
Myrtle Beach, South Carolina, United States
Urology Associates of Nashville
Nashville, Tennessee, United States
Urology Clinics of North Texas
Dallas, Texas, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
The Urology Place
San Antonio, Texas, United States
Intermountain Health
Murray, Utah, United States
University of Wisconsin
Madison, Wisconsin, United States
St. Vincent's Sydney
Sydney, New South Wales, Australia
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, Australia
Countries
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Central Contacts
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Facility Contacts
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Jack Andrews, MD
Role: primary
Gholam R. Berenji, MD
Role: primary
Hong Song, MD, PhD
Role: primary
Ephraim Parent, MD
Role: primary
Brian Helfand, MD
Role: primary
Brian Lane, MD, PhD
Role: primary
Jeffrey Karnes, MD
Role: primary
Shaun GS Grewal, MD
Role: primary
Bryan Mehllhaff, MD
Role: primary
David Morris, MD
Role: primary
Alexander Parker, MD
Role: primary
Radiology Clinical Research Office
Role: backup
Naveen Kella, MD
Role: primary
Dustin L. Boothe, MD
Role: primary
Steve Y Cho, MD
Role: primary
Louise Emmett, MD
Role: primary
Ian Vela, MD
Role: primary
Dickon Hayne, MD
Role: primary
Other Identifiers
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CLP04
Identifier Type: -
Identifier Source: org_study_id