Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy
- Registration Number
- NCT06056830
- Lead 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Male
- Target Recruitment
- 383
- 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.
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 64Cu-SAR-bisPSMA 64Cu-SAR-bisPSMA 200MBq 64Cu-SAR-bisPSMA.
- Primary Outcome Measures
Name Time Method Diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases 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.
- Secondary Outcome Measures
Name Time Method Safety and tolerability of 64Cu-SAR-bisPSMA Up to 16 weeks Incidence and severity of treatment-emergent AEs and SAEs following administration of 64Cu-SAR-bisPSMA
Consistency of 64Cu-SAR-bisPSMA PET/CT interpretations for the three central readers Up to 16 weeks Inter-reader reliability of agreement estimated with a multiple-reader kappa statistic
PPV and NPV of 64Cu-SAR-bisPSMA PET to detect PC within the pelvic LNs 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
Ability of 64Cu-SAR-bisPSMA PET to detect Prostate Cancer Up to 16 weeks Sensitivity of 64Cu-SAR-bisPSMA PET to detect PC within the prostate gland compared to the Standard of Truth
Diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases without subregion matching 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
Trial Locations
- Locations (23)
Indiana University School of Medicine
🇺🇸Indianapolis, Indiana, United States
Mount Sinai Doctors Urology Faculty Practice
🇺🇸New York, New York, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
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
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
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
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