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

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Clarity Pharmaceuticals Ltd
Study ID
NCT06056830
Phase
PHASE3
Status
Recruiting

Conditions

Eligibility Criteria

Sex
MALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 64Cu-SAR-bisPSMA — DRUG
    All Patients will receive a single administration, a bolus injection of 200MBq 64Cu-SAR-bisPSMA.

Study Details

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

Key Dates

Start date
Dec 21, 2023
Status verified
May 2026
Primary completion
Sep 30, 2026
Completion
Sep 30, 2026

Study Design

Enrollment
383 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Arms

  • Experimental: 64Cu-SAR-bisPSMA
    200MBq 64Cu-SAR-bisPSMA.

Primary Outcome Measure

Diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases [ Time Frame: Up to 16 weeks ]

Central Contacts

Locations (27)

FacilityCityStateZIPSite coordinators
University of Alabama Birmingham HospitalBirminghamAlabama35249-6830
Ashley Barnes
205-996-5784
Sebastian Eady
205-996-2636
Jonathan E McConathy, MD, PhD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic- PhoenixPhoenixArizona85054
Jack Andrews, MD
Arkansas Urology Research Center, LLCLittle RockArkansas72211
Katie
5012198900
Sarah
5012198900
R. Jonathan Henderson, MD (PRINCIPAL_INVESTIGATOR)
Greater Los Angeles VA Medical CenterLos AngelesCalifornia90073
Gholam R. Berenji, MD
Urology Group of Southern CaliforniaLos AngelesCalifornia90017
Carlos Lopez
Yvette Zuniga
John Kowalczyk (PRINCIPAL_INVESTIGATOR)
UC Irvine HealthOrangeCalifornia92868
877-827-8839
Edward Uchio, MD, FACS, CPI (PRINCIPAL_INVESTIGATOR)
Stanford University Medical CenterStanfordCalifornia94305-5105
Hong Song, MD, PhD
Mayo Clinic- JacksonvilleJacksonvilleFlorida32224
Ephraim Parent, MD
Biogenix Molecular, LLCMiamiFlorida33165
Jerry Joseph, FMD
786-791-1799
Serguei A Castaneda, MD (PRINCIPAL_INVESTIGATOR)
NorthShore University Health System, Glenbrook HospitalGlenviewIllinois60026
Brian Helfand, MD
Indiana University School of MedicineIndianapolisIndiana46202
Ashlee Frazee, PhD
(317)278-4959
Clint D Bahler, MD (PRINCIPAL_INVESTIGATOR)
Wichita Urology GroupWichitaKansas67226
Timothy Richardson, MD (PRINCIPAL_INVESTIGATOR)
BAMF HealthGrand RapidsMichigan49503
Clayton McNamara
Harshad Kulkarni, MD (PRINCIPAL_INVESTIGATOR)
Corewell HealthGrand RapidsMichigan49503
Josh Dejong
616-267-7566
Rachel Schmidt, BSN, RN
616-486-1545
Conrad Tobert (PRINCIPAL_INVESTIGATOR)
Mayo Clinic- RochesterRochesterMinnesota55905
Jeffrey Karnes, MD
XCancer Omaha LLCOmahaNebraska68130
Tony Romero
402-991-8468
Luke Nordquist, MD (PRINCIPAL_INVESTIGATOR)
Mount Sinai Doctors Urology Faculty PracticeNew YorkNew York10029
Monali Fatterpekar
212-241-9955
Ashutosh Tewari, MD (PRINCIPAL_INVESTIGATOR)
Duke University Medical CenterDurhamNorth Carolina27710
Alex Sents, MA, MPH
(919) 668-0739
Terence Z Wong, MD, PhD, FACR (PRINCIPAL_INVESTIGATOR)
Judd W Moul, MD, FACS (PRINCIPAL_INVESTIGATOR)
Urologic SpecialistsTulsaOklahoma74146
Shaun GS Grewal, MD
Oregon UrologySpringfieldOregon97477
Bryan Mehllhaff, MD
Carolina Urologic Research CenterMyrtle BeachSouth Carolina29572
Neal Shore, MD (PRINCIPAL_INVESTIGATOR)
Urology Associates of NashvilleNashvilleTennessee37209
David Morris, MD
University of Texas Southwestern Medical CenterDallasTexas75390-8896
Orhan Oz, MD
214-645-1568
Radiology Clinical Research Office
Urology Clinics of North TexasDallasTexas75231
Alexander Parker, MD
The Urology PlaceSan AntonioTexas78240
Naveen Kella, MD
Intermountain HealthMurrayUtah84107
Dustin L. Boothe, MD
University of WisconsinMadisonWisconsin53705
Nandakumar Menon, MD

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