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Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy
NCT06056830 · Clarity Pharmaceuticals Ltd
In plain English
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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
About this study
The aim for this study is to assess the diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases.
Eligibility 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.
Study design
Enrollment target: 383 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2023-12-21
Estimated completion: 2026-09
Last updated: 2026-04-09
Interventions
Drug: 64Cu-SAR-bisPSMA
Primary outcomes
- • Diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases (Up to 16 weeks)
Sponsor
Clarity Pharmaceuticals Ltd · industry
Contacts & investigators
ContactClarity Pharmaceuticals · contact · clinicaltrials@claritypharmaceuticals.com · +61 (0) 2 9209 4037
InvestigatorClarity Pharmaceuticals · study_director, Clarity Pharmaceuticals
All locations (27)
University of Alabama Birmingham HospitalRecruiting
Birmingham, Alabama, United States
Mayo Clinic- PhoenixRecruiting
Phoenix, Arizona, United States
Urology Group of Southern CaliforniaRecruiting
Los Angeles, California, United States
Greater Los Angeles VA Medical CenterRecruiting
Los Angeles, California, United States
Stanford University Medical CenterRecruiting
Stanford, California, United States
Mayo Clinic- JacksonvilleRecruiting
Jacksonville, Florida, United States
Biogenix Molecular, LLCRecruiting
Miami, Florida, United States
NorthShore University Health System, Glenbrook HospitalRecruiting
Glenview, Illinois, United States
Indiana University School of MedicineRecruiting
Indianapolis, Indiana, United States
BAMF HealthRecruiting
Grand Rapids, Michigan, United States
Corewell HealthRecruiting
Grand Rapids, Michigan, United States
Mayo Clinic- RochesterRecruiting
Rochester, Minnesota, United States
XCancer Omaha LLCRecruiting
Omaha, Nebraska, United States
Mount Sinai Doctors Urology Faculty PracticeRecruiting
New York, New York, United States
Duke University Medical CenterRecruiting
Durham, North Carolina, United States
Urologic SpecialistsRecruiting
Tulsa, Oklahoma, United States
Oregon UrologyRecruiting
Springfield, Oregon, United States
Carolina Urologic Research CenterRecruiting
Myrtle Beach, South Carolina, United States
Urology Associates of NashvilleRecruiting
Nashville, Tennessee, United States
Urology Clinics of North TexasRecruiting
Dallas, Texas, United States
University of Texas Southwestern Medical CenterRecruiting
Dallas, Texas, United States
The Urology PlaceRecruiting
San Antonio, Texas, United States
Intermountain HealthRecruiting
Murray, Utah, United States
University of WisconsinRecruiting
Madison, Wisconsin, United States
St. Vincent's SydneyRecruiting
Sydney, New South Wales, Australia
Princess Alexandra HospitalRecruiting
Woolloongabba, Queensland, Australia
Fiona Stanley HospitalRecruiting
Murdoch, Western Australia, Australia