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

NCT06056830 | Recruiting Phase 3 FDA Drug

• 1 other identifier: CLP04
• Study Type: interventional
• Target: 383
• Locations: 3 countries
• Sites: 28

Brief Summary

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

Conditions

Prostate Cancer; Prostatic Neoplasms

Outcome Measures

Primary Outcomes (1)

• Diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases

  Independent primary endpoints for Day 1 and Day 2 PET: Co-primary endpoint of sensitivity and specificity of 64Cu-SAR-bisPSMA PET to detect Prostate Cancer within the pelvic lymph nodes compared to the Standard of Truth.

  Up to 16 weeks

Secondary Outcomes (5)

• Safety and tolerability of 64Cu-SAR-bisPSMA

  Up to 16 weeks

• Consistency of 64Cu-SAR-bisPSMA PET/CT interpretations for the three central readers

  Up to 16 weeks

• PPV and NPV of 64Cu-SAR-bisPSMA PET to detect PC within the pelvic LNs

  Up to 16 weeks

• Ability of 64Cu-SAR-bisPSMA PET to detect Prostate Cancer

  Up to 16 weeks

• Diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases without subregion matching

  Up to 16 weeks

Study Arms (1)

64Cu-SAR-bisPSMA

EXPERIMENTAL

200MBq 64Cu-SAR-bisPSMA.

Drug: 64Cu-SAR-bisPSMA

Interventions

64Cu-SAR-bisPSMA DRUG

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

64Cu-SAR-bisPSMA

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You 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 may not qualify 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.

Sponsors & Collaborators

• Clarity Pharmaceuticals Ltd: lead

Study Sites (28)

University of Alabama Birmingham Hospital

Birmingham, Alabama, 35249-6830, United States

RECRUITING

Mayo Clinic- Phoenix

Phoenix, Arizona, 85054, United States

RECRUITING

Urology Group of Southern California

Los Angeles, California, 90017, United States

RECRUITING

Greater Los Angeles VA Medical Center

Los Angeles, California, 90073, United States

RECRUITING

Stanford University Medical Center

Stanford, California, 94305-5105, United States

RECRUITING

Mayo Clinic- Jacksonville

Jacksonville, Florida, 32224, United States

RECRUITING

Biogenix Molecular, LLC

Miami, Florida, 33165, United States

RECRUITING

NorthShore University Health System, Glenbrook Hospital

Glenview, Illinois, 60026, United States

RECRUITING

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

RECRUITING

BAMF Health

Grand Rapids, Michigan, 49503, United States

RECRUITING

Corewell Health

Grand Rapids, Michigan, 49503, United States

RECRUITING

Mayo Clinic- Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

XCancer Omaha LLC

Omaha, Nebraska, 68130, United States

RECRUITING

Mount Sinai Doctors Urology Faculty Practice

New York, New York, 10029, United States

RECRUITING

Duke University Medical Center

Durham, North Carolina, 27710, United States

RECRUITING

Urologic Specialists

Tulsa, Oklahoma, 74146, United States

RECRUITING

Oregon Urology

Springfield, Oregon, 97477, United States

RECRUITING

Carolina Urologic Research Center

Myrtle Beach, South Carolina, 29572, United States

RECRUITING

Urology Associates of Nashville

Nashville, Tennessee, 37209, United States

RECRUITING

Urology Clinics of North Texas

Dallas, Texas, 75231, United States

RECRUITING

University of Texas Southwestern Medical Center

Dallas, Texas, 75390-8896, United States

RECRUITING

The Urology Place

San Antonio, Texas, 78240, United States

RECRUITING

Intermountain Health

Murray, Utah, 84107, United States

RECRUITING

University of Wisconsin

Madison, Wisconsin, 53705, United States

RECRUITING

St. Vincent's Sydney

Sydney, New South Wales, Australia

RECRUITING

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

RECRUITING

Fiona Stanley Hospital

Murdoch, Western Australia, 6150, Australia

RECRUITING

Pan American Center for Oncology Trials, LLC - Ciudadela

San Juan, 00918, Puerto Rico

RECRUITING

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Clarity Pharmaceuticals

  Clarity Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Clarity Pharmaceuticals

CONTACT

+61 (0) 2 9209 4037; clinicaltrials@claritypharmaceuticals.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2023
• First Posted: September 28, 2023
• Study Start: December 21, 2023
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: May 6, 2026

Record last verified: 2026-05

Locations

AU (3); US (24); PR (1)