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

RECRUITINGPhase 3Sponsored by Clarity Pharmaceuticals Ltd
Actively Recruiting
PhasePhase 3
SponsorClarity Pharmaceuticals Ltd
Started2023-12-21
Est. completion2026-09
Eligibility
Age18 Years+
SexMALE
Healthy vol.Accepted
Locations24 sites
View on ClinicalTrials.gov →

NCT06056830

Summary

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

Eligibility

Age: 18 Years+Sex: MALEHealthy volunteers accepted
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.

Conditions3

CancerProstate CancerProstatic Neoplasms

Interventions1

64Cu-SAR-bisPSMA

Locations24 sites

University of Alabama Birmingham Hospital
Birmingham, Alabama, 35249-6830
Ashley Barnes205-996-5784alstrickland@uabmc.edu
Mayo Clinic- Phoenix
Phoenix, Arizona, 85054
Jack Andrews, MD
Urology Group of Southern California
Los Angeles, California, 90017
Carlos Lopezclopez@folioclinicalresearch.com
Greater Los Angeles VA Medical Center
Los Angeles, California, 90073
Gholam R. Berenji, MD
Stanford University Medical Center
Stanford, California, 94305-5105
Hong Song, MD, PhD

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