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NCT06056830 | RECRUITING | Prostate Cancer

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

Clarity Pharmaceuticals Ltd

Brief Summary:

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

Condition or disease

Prostate Cancer

Prostatic Neoplasms

Intervention/treatment

64Cu-SAR-bisPSMA

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 383 participants
Masking : NONE
Primary Purpose : DIAGNOSTIC
Official Title : 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
Actual Study Start Date : 2023-12-21
Estimated Primary Completion Date : 2025-12
Estimated Study Completion Date : 2025-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: MALE
Accepts Healthy Volunteers:
Criteria
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.
Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy

Location Details

NCT06056830

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Arizona

Mayo Clinic- Phoenix

Phoenix, Arizona, United States, 85054

RECRUITING

United States, California

Greater Los Angeles VA Medical Center

Los Angeles, California, United States, 90073

RECRUITING

United States, California

Stanford University Medical Center

Stanford, California, United States, 94305-5105

RECRUITING

United States, Florida

Mayo Clinic- Jacksonville

Jacksonville, Florida, United States, 32224

RECRUITING

United States, Illinois

NorthShore University Health System

Glenview, Illinois, United States, 60026

NOT YET RECRUITING

United States, Indiana

Indiana University School of Medicine

Indianapolis, Indiana, United States, 46202

RECRUITING

United States, Road cancer

BAMF Health

Grand Rapids, Road cancer, United States, 49503

RECRUITING

United States, Road cancer

Corewell Health

Grand Rapids, Road cancer, United States, 49503

RECRUITING

United States, Minnesota

Mayo Clinic- Rochester

Rochester, Minnesota, United States, 55905

RECRUITING

United States, Nebraska

XCancer Omaha LLC

Omaha, Nebraska, United States, 68130

RECRUITING

United States, New York

Mount Sinai Doctors Urology Faculty Practice

New York, New York, United States, 10029

RECRUITING

United States, Oklahola

Urologic Specialists

Tulsa, Okholohan, United States, 74146

RECRUITING

United States, Oregon

Oregon Urology

Springfield, Oregon, United States, 97477

RECRUITING

United States, South Carolina

Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States, 29572

RECRUITING

United States, Tennessee

Urology Associates of Nashville

Nashville, Tennessee, United States, 37209

RECRUITING

United States, Texas

Urology Clinics of North Texas

Dallas, Texas, United States, 75231

RECRUITING

United States, Texas

University of Texas Southwestern Medical Center

Dallas, Texas, United States, 75390-8896

RECRUITING

United States, Texas

The Urology Place

San Antonio, Texas, United States, 78240

RECRUITING

United States, Utah

Intermountain Health

Murray, Utah, United States, 84107

RECRUITING

United States, Wisconsin

University of Wisconsin

Madison, Wisconsin, United States, 53705

RECRUITING

Australia, New South Wales

St. Vincent's Sydney

Sydney, New South Wales, Australia,

RECRUITING

Australia, Queensland

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia,

RECRUITING

Australia, Western Australia

Fiona Stanley Hospital

Murdoch, Western Australia, Australia, 6150