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

Phase 3

Recruiting

• Conditions: Prostate Cancer; Prostatic Neoplasms
• Interventions: Drug: 64Cu-SAR-bisPSMA

• Registration Number: NCT06056830
• Lead Sponsor: Clarity Pharmaceuticals Ltd

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-09-21
• Study First Submitted QC: 2023-09-21
• Study First Posted: 2023-09-28
• Study Start: 2023-11-30
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-16
• Last Update Posted: 2024-12-17
• Primary Completion: 2025-02
• Study Completion: 2025-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 383

Inclusion Criteria

• 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.

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Exclusion Criteria

• 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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
64Cu-SAR-bisPSMA	64Cu-SAR-bisPSMA	200MBq 64Cu-SAR-bisPSMA.

Primary Outcome Measures

Name	Time	Method
Diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases	Up to 16 weeks	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.

Secondary Outcome Measures

Name	Time	Method
Safety and tolerability of 64Cu-SAR-bisPSMA	Up to 16 weeks	Incidence and severity of treatment-emergent AEs and SAEs following administration of 64Cu-SAR-bisPSMA
Consistency of 64Cu-SAR-bisPSMA PET/CT interpretations for the three central readers	Up to 16 weeks	Inter-reader reliability of agreement estimated with a multiple-reader kappa statistic
PPV and NPV of 64Cu-SAR-bisPSMA PET to detect PC within the pelvic LNs	Up to 16 weeks	PPV and NPV of 64Cu-SAR-bisPSMA PET to detect PC within the pelvic LNs compared to the Standard of Truth
Ability of 64Cu-SAR-bisPSMA PET to detect Prostate Cancer	Up to 16 weeks	Sensitivity of 64Cu-SAR-bisPSMA PET to detect PC within the prostate gland compared to the Standard of Truth
Diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases without subregion matching	Up to 16 weeks	Sensitivity and specificity of 64Cu-SAR-bisPSMA PET to detect PC within the pelvic LNs compared to the Standard of Truth, without the requirement of subregion (Left or Right) matching between 64Cu-SAR-bisPSMA PET and Standard of Truth

Trial Locations

Locations (21)

Fiona Stanley Hospital; 🇦🇺 Murdoch, Western Australia, Australia

Mayo Clinic- Phoenix; 🇺🇸 Phoenix, Arizona, United States

Greater Los Angeles VA Medical Center; 🇺🇸 Los Angeles, California, United States

Stanford University Medical Center; 🇺🇸 Stanford, California, United States

Mayo Clinic- Jacksonville; 🇺🇸 Jacksonville, Florida, United States

NorthShore University Health System; 🇺🇸 Glenview, Illinois, United States

BAMF Health; 🇺🇸 Grand Rapids, Michigan, United States

Corewell Health; 🇺🇸 Grand Rapids, Michigan, United States

Mayo Clinic- Rochester; 🇺🇸 Rochester, Minnesota, United States

XCancer Omaha LLC; 🇺🇸 Omaha, Nebraska, United States

Urologic Specialists; 🇺🇸 Tulsa, Oklahoma, United States

Oregon Urology; 🇺🇸 Springfield, Oregon, United States

Carolina Urologic Research Center; 🇺🇸 Myrtle Beach, South Carolina, United States

Urology Associates of Nashville; 🇺🇸 Nashville, Tennessee, United States

Urology Clinics of North Texas; 🇺🇸 Dallas, Texas, United States

UT Southwest Medical Center; 🇺🇸 Dallas, Texas, United States

The Urology Place; 🇺🇸 San Antonio, Texas, United States

Intermountain Health; 🇺🇸 Murray, Utah, United States

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States

St. Vincent's Sydney; 🇦🇺 Sydney, New South Wales, Australia

Princess Alexandra Hospital; 🇦🇺 Woolloongabba, Queensland, Australia