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
Status: Recruiting
Location: See all (23) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY
The aim for this study is to assess the diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases.
Eligibility
Participation Requirements
Sex: Male
Minimum Age: 18
Healthy Volunteers: f
View:
• 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.
Locations
United States
Arizona
Mayo Clinic- Phoenix
RECRUITING
Phoenix
California
Greater Los Angeles VA Medical Center
RECRUITING
Los Angeles
Stanford University Medical Center
RECRUITING
Stanford
Florida
Mayo Clinic- Jacksonville
RECRUITING
Jacksonville
Illinois
NorthShore University Health System
RECRUITING
Glenview
Indiana
Indiana University School of Medicine
RECRUITING
Indianapolis
Michigan
BAMF Health
RECRUITING
Grand Rapids
Corewell Health
RECRUITING
Grand Rapids
Minnesota
Mayo Clinic- Rochester
RECRUITING
Rochester
Nebraska
XCancer Omaha LLC
RECRUITING
Omaha
New York
Mount Sinai Doctors Urology Faculty Practice
RECRUITING
New York
Oklahoma
Urologic Specialists
RECRUITING
Tulsa
Oregon
Oregon Urology
RECRUITING
Springfield
South Carolina
Carolina Urologic Research Center
RECRUITING
Myrtle Beach
Tennessee
Urology Associates of Nashville
RECRUITING
Nashville
Texas
University of Texas Southwestern Medical Center
RECRUITING
Dallas
Urology Clinics of North Texas
RECRUITING
Dallas
The Urology Place
RECRUITING
San Antonio
Utah
Intermountain Health
RECRUITING
Murray
Wisconsin
University of Wisconsin
RECRUITING
Madison
Other Locations
Australia
Fiona Stanley Hospital
RECRUITING
Murdoch
St. Vincent's Sydney
RECRUITING
Sydney
Princess Alexandra Hospital
RECRUITING
Woolloongabba
Contact Information
Primary
Clarity Pharmaceuticals
clinicaltrials@claritypharmaceuticals.com
+61 (0) 2 9209 4037
Time Frame
Start Date: 2023-12-21
Estimated Completion Date: 2026-09
Participants
Target number of participants: 383
Treatments
Experimental: 64Cu-SAR-bisPSMA
200MBq 64Cu-SAR-bisPSMA.
Related Therapeutic Areas
Sponsors
Leads: Clarity Pharmaceuticals Ltd