Prostate Cancer Clinical Trial

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

Summary

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

View Eligibility Criteria

Eligibility Criteria

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.

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.

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

383

Study ID:

NCT06056830

Recruitment Status:

Recruiting

Sponsor:

Clarity Pharmaceuticals Ltd

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There are 5 Locations for this study

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NorthShore University Health System
Glenview Illinois, 60026, United States More Info
Brian Helfand, MD
Contact
XCancer Omaha LLC
Omaha Nebraska, 68130, United States More Info
Tony Romero
Contact
402-991-8468
[email protected]
Luke Nordquist, MD
Principal Investigator
Urologic Specialists
Tulsa Oklahoma, 74146, United States More Info
Shaun GS Grewal, MD
Contact
Carolina Urologic Research Center
Myrtle Beach South Carolina, 29572, United States More Info
Neal Shore, MD
Principal Investigator
The Urology Place
San Antonio Texas, 78240, United States More Info
Naveen Kella, MD
Contact

How clear is this clinincal trial information?

Study is for people with:

Prostate Cancer

Phase:

Phase 3

Estimated Enrollment:

383

Study ID:

NCT06056830

Recruitment Status:

Recruiting

Sponsor:


Clarity Pharmaceuticals Ltd

How clear is this clinincal trial information?

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