Phase 3 Trial of Copper Cu 64 PSMA I&T PET/CT Imaging in Men with Newly Diagnosed Prostate Cancer (Solar-Stage)

Description:

Solar-Stage is a single-arm prospective study. Treating physicians will not be blinded to the imaging results. Local read of the copper Cu 64 PSMA I&T PET/CT can be used to inform patient management. For the co-primary endpoints, PET/CT scans will be read by blinded independent reviewers.

Sponsor:

Curium

Contacts:

Darcy Denner, Ph.D. (Clinical Trial Director)

darcy.denner@curiumpharma.com

Government Study Link:

NCT06235151 - Click here to see study on

ClinicalTrials.gov

Cu 64 PSMA I&T

Isotope(s):

Target(s):

PSMA

Ligand: Small Molecules

Chelator: DOTAGA

Inclusion

Planned radical prostatectomy (RP) with pelvic lymph node dissection (PLND)
Unfavorable intermediate-risk, high-risk, or very-high-risk disease defined by NCCN Guidelines in Oncology Version 1
Male aged ≥18 years
Histologically proven prostate adenocarcinoma

Exclusion

ADT, neoadjuvant chemotherapy, radiation therapy (including local ablation techniques), or investigational therapy in PC
PSMA PET within 90 days prior to enrollment

Patient Education

Publications

Publications Not Yet Provided

Locations

United States 🇺🇸

XCancer - Omaha

17607 Gold Plaza, Omaha, Nebraska 68130, United States

Principal Investigator

Luke T. Nordquist, MD

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Carolina Urologic Research Center

Myrtle Beach, South Carolina, United States

Principal Investigator

Neal Shore, MD

View Profile

University of Iowa Medical Center

Iowa City, Iowa, United States

Principal Investigator

Janet Pollard, MD

University of California Irvine Chao Family Comprehensive Cancer Center

Orange, California, United States

Principal Investigator

Edward Uchio, MD

University of North Carolina Chapel Hill

Chapel Hill, North Carolina, United States

Principal Investigator

Steven Rowe, MD, PhD

Minnesota Oncology

Maplewood, Minnesota, United States

Principal Investigator

Ryan Funk, MD

University of Maryland Greenebaum Cancer Center

Baltimore, Maryland, United States

Principal Investigator

Arif Hussain, MD

University of California, San Francisco

San Francisco, California 94158, United States

Principal Investigator

Samuel Washington, MD - UCSF

Arkansas Urology

Little Rock, Arkansas, United States

Principal Investigator

Jeffrey Marotte, MD

Excel Diagnostics & Nuclear Oncology Center

Houston, Texas, United States

Principal Investigator

Kanwal Siddiqui, MD

Queens Hospital Center

Queens, New York, United States

Principal Investigator

Isuru Jayarantna, MD

University of Miami Miller School of Medicine-Sylvester Cancer Center

Miami, Florida, United States

Principal Investigator

Sanoj Punnen, MD

Urology San Antonio

San Antonio, Texas 78229, United States

Principal Investigator

Daniel Saltzstein, MD

Stanford University Medical Center

Stanford, California 94305, United States

Principal Investigator

Farshad Moradi, MD

University of Kansas Cancer Center

Kansas City, Kansas, United States

Principal Investigator

William Parker, MD

John Cohchran VA St. Louis Health Care System

St. Louis, Missouri, United States

Principal Investigator

Medhat Osman, MD, PhD

Great Plains Health

North Platte, Nebraska, United States

Principal Investigator

Ladd Lake, MD

Portland VA Medical Center

Portland, Oregon, United States

Principal Investigator

Julie Graff, MD

Hoag Memorial Hospital Presbyterian

Newport Beach, California, United States

Principal Investigator

Gary Ulaner, MD

SSM Saint Louis University Hospital

St. Louis, Missouri 63104, United States

Principal Investigator

Medhat Osman, MD, PhD - SLU

Medstar Georgetown University Hospital

Washington, District of Columbia, United States

Principal Investigator

Paul Leger, MD

University of Washington/Fred Hutchinson Cancer Center

Seattle, Washington 98109, United States

Principal Investigator

Amir Iravani, MD

SUNY Upstate Medical Center

Syracuse, New York, United States

Principal Investigator

Gennady Bratslavsky, MD

Providence Saint John's Health Center

Santa Monica, California 90404, United States

Principal Investigator

Przemyslaw Twardowski, MD

Washington University School of Medicine

St. Louis, Missouri, United States

Principal Investigator

Michael Johnson, MD

Providence Medical Foundation

Fullerton, California 92835, United States

Principal Investigator

Sanjay Sharma, MD

VA Greater Los Angeles Healthcare System

Los Angeles, California, United States

Principal Investigator

Gholam Berenji, MD

University of Minnesota

Minneapolis, Minnesota, United States

Principal Investigator

Subodh Regmi, MD

Indiana University School of Medicine

Indianapolis, Indiana, United States

Principal Investigator

Mark Tann, MD

Urology Clinics of North Texas

Dallas, Texas, United States

Principal Investigator

Wilson Hernandez, MD

University of Toledo Medical Center

Toledo, Ohio, United States

Principal Investigator

Firas Petros, MD

Medical University of South Carolina

Charleston, South Carolina 29425, United States

Principal Investigator

Stephen Savage, MD

Boston VA

Boston, Massachusetts, United States

Principal Investigator

Yamin Dou, MD

Florida Urology Partners, LLP

Tampa, Florida 33607, United States

Principal Investigator

Osvaldo Padron, MD

University of Tennessee Medical Center

Knoxville, Tennessee 37920, United States

Principal Investigator

Wesley White, MD

Biogenix Molecular LLC

Miami, Florida 33165, United States

Principal Investigator

Frankis Almaguel, MD

San Francisco VA Health Care System

San Francisco, California 94121, United States

Principal Investigator

Samuel Washington, MD

Sarasota Memorial Healthcare

Sarasota, Florida, United States

Principal Investigator

Robert Carey, MD

Imaging West: Adaptive Research

Hawthorne, New York, United States

Principal Investigator

Christopher Riedl, MD, PhD

Cleveland Clinic Florida

Weston, Florida, United States

Principal Investigator

Darko Pucar, MD

Urology of Indiana

Danville, Indiana, United States

Principal Investigator

Ronald Suh, MD

Cleveland Clinic Ohio

Cleveland, Ohio, United States

Principal Investigator

Paresh Mahajan, MD

Columbia University Medical Center - Herbert Irving Pavilion

New York, New York, United States

Principal Investigator

Mark Stein, MD

Edward Hines Jr. VA Health Care System

Hines, Illinois, United States

Principal Investigator

Erica Cohen-Major, DO

University of Arizona Medical Center

Tucson, Arizona, United States

Principal Investigator

Bital Savir-Baruch, MD

Beverly Hills Cancer Center

Los Angeles, California, United States

Principal Investigator

Afshin Gabayan, MD

Tower Urology

Los Angeles, California 90048, United States

Contact XCancer: 402-991-8468