What this study is
The aim for this study is to assess the diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases.
What's being tested
- 64Cu-SAR-bisPSMA
Intervention · DRUG
All Patients will receive a single administration, a bolus injection of 200MBq 64Cu-SAR-bisPSMA.
Study details
- 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
- Sponsor
- Clarity Pharmaceuticals Ltd
- Conditions
- Prostate Cancer · Prostatic Neoplasms
- Enrolling
- 383 people
- Starts
- 2023-12-21
- Est. completion
- 2026-09
- Design
- Open-label, single group, Phase 3
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex MALEHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (34)
34 openUniversity of Alabama Birmingham Hospital
Birmingham, Alabama, United States
- Ashley Barnes · Contact205-996-5784alstrickland@uabmc.edu
- Sebastian Eady · Contact205-996-2636smeady@uabmc.edu
- Deepak Kalbi, MD · Principal investigator
RecruitingMayo Clinic- Phoenix
Phoenix, Arizona, United States
- Jack Andrews, MD · Contact
RecruitingArkansas Urology Research Center, LLC
Little Rock, Arkansas, United States
- Katie · Contact5012198900 ext. 9039research@arkansasurology.com
- Sarah · Contact5012198900 ext. 2002research@arkansasurology.com
- R. Jonathan Henderson, MD · Principal investigator
RecruitingUrology Group of Southern California
Los Angeles, California, United States
- Carlos Lopez · Contactclopez@folioclinicalresearch.com
- Yvette Zuniga · Contactyzuniga@folioclinicalresearch.com
- John Kowalczyk · Principal investigator
RecruitingGreater Los Angeles VA Medical Center
Los Angeles, California, United States
- Gholam R. Berenji, MD · Contact
RecruitingUC Irvine Health
Orange, California, United States
- Contact877-827-8839ucstudy@hs.uci.edu
- Edward Uchio, MD, FACS, CPI · Principal investigator
RecruitingStanford University Medical Center
Stanford, California, United States
- Hong Song, MD, PhD · Contact
RecruitingMayo Clinic- Jacksonville
Jacksonville, Florida, United States
- Ephraim Parent, MD · Contact
RecruitingBiogenix Molecular, LLC
Miami, Florida, United States
- Jerry Joseph, FMD · Contact786-791-1799jjoseph@cira-health.com
- Cesar A Santana, MD, PhD · Principal investigator
RecruitingNorthShore University Health System, Glenbrook Hospital
Glenview, Illinois, United States
- Brian Helfand, MD · Contact
RecruitingIndiana University School of Medicine
Indianapolis, Indiana, United States
- Ashlee Frazee, PhD · Contact(317)278-4959amfrazee@iu.edu
- Clint D Bahler, MD · Principal investigator
RecruitingWichita Urology Group
Wichita, Kansas, United States
- Timothy Richardson, MD · Contact316-636-6141
- Tyler Gentry, CCRC · Contact316-636-6141TGENTRY@WichitaUrology.com
- Timothy Richardson, MD · Principal investigator
RecruitingBAMF Health
Grand Rapids, Michigan, United States
- Clayton McNamara · ContactResearchClinicalTeam@bamfhealth.com
- Harshad Kulkarni, MD · Principal investigator
RecruitingCorewell Health
Grand Rapids, Michigan, United States
- Josh Dejong · Contact616-267-7566joshua.dejong@corewellhealth.org
- Rachel Schmidt, BSN, RN · Contact616-486-1545rachel.schmidt@corewellhealth.org
- Conrad Tobert · Principal investigator
RecruitingMayo Clinic- Rochester
Rochester, Minnesota, United States
- Jeffrey Karnes, MD · Contact
RecruitingXCancer Omaha LLC
Omaha, Nebraska, United States
- Tony Romero · Contact402-991-8468tromero@gucancer.com
- Luke Nordquist, MD · Principal investigator
RecruitingAlbany Medical College, Department of Urology
Albany, New York, United States
- Ronald Kaufman, MD · Contact518-262-8579AMCUrologyResearch@amc.edu
- Ronald Kaufman, MD · Principal investigator
RecruitingMount Sinai Doctors Urology Faculty Practice
New York, New York, United States
- Monali Fatterpekar · Contact212-241-9955monali.fatterpekar@mountsinai.org
- Ashutosh Tewari, MD · Principal investigator
RecruitingDuke University Medical Center
Durham, North Carolina, United States
- Alex Sents, MA, MPH · Contact(919) 668-0739alex.sents@duke.edu
- Terence Z Wong, MD, PhD, FACR · Principal investigator
- Judd W Moul, MD, FACS · Principal investigator
RecruitingUrologic Specialists
Tulsa, Oklahoma, United States
- Shaun GS Grewal, MD · Contact
RecruitingOregon Urology
Springfield, Oregon, United States
- Bryan Mehllhaff, MD · Contact
RecruitingCarolina Urologic Research Center
Myrtle Beach, South Carolina, United States
- Neal Shore, MD · Principal investigator
RecruitingUrology Associates of Nashville
Nashville, Tennessee, United States
- David Morris, MD · Contact
RecruitingUrology Austin, PLLC - Research Department
Austin, Texas, United States
- Jennifer Penshorn, RN, CCRC · Contact512-410-3773jennifer.penshorn@urologyaustin.com
- Michael Egenes · Contact512-410-3773Michael.Egenes@urologyaustin.com
- Brian Mazzarella, MD · Principal investigator
RecruitingUrology Clinics of North Texas
Dallas, Texas, United States
- Alexander Parker, MD · Contact
RecruitingUniversity of Texas Southwestern Medical Center
Dallas, Texas, United States
- Orhan Oz, MD · Contact214-645-1568RCRO@UTSouthwestern.edu
- Radiology Clinical Research Office · Contact
RecruitingThe Urology Place
San Antonio, Texas, United States
- Naveen Kella, MD · Contact
RecruitingIntermountain Health
Murray, Utah, United States
- Dustin L. Boothe, MD · Contact
RecruitingUniversity of Wisconsin
Madison, Wisconsin, United States
- Nandakumar Menon, MD · Contact
Recruiting
5 sites outside the US
St. Vincent's Sydney
Sydney, New South Wales, Australia
- Louise Emmett, MD · Contact
RecruitingPrincess Alexandra Hospital
Woolloongabba, Queensland, Australia
- Ian Vela, MD · Contact
RecruitingFiona Stanley Hospital
Murdoch, Western Australia, Australia
- Dickon Hayne, MD · Contact
RecruitingRAMSAY HEALTH CARE AUSTRALIA PTY LIMITED (ABN 36 003 184 889) trading as Hollywood Private Hospital
Nedlands, Western Australia, Australia
- Eilish McCarthy · Contact08 9346 6022McCarthyEilish@ramsayhealth.com.au
- Sally Cronan · Contact08 9346 6022cronans@ramsayhealth.com.au
- Dr. Tom Shannon · Principal investigator
RecruitingPan American Center for Oncology Trials, LLC - Ciudadela
San Juan, Puerto Rico
- Christina De La Cruz, Lead CRC · Contact787-407-3333Christina.delacruz@panoncologytrials.com
- Isamar Alicea (Site Manager), Dra. · Contact787-407-3333Isamar.alicea@panoncologytrials.com
- Ricardo F Sanchez Ortiz, MD, FACS · Principal investigator
Recruiting
Study team
Sponsor
Clarity Pharmaceuticals Ltd
Study ID CLP04
Study director
Clarity Pharmaceuticals
Clarity Pharmaceuticals
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.