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

ID#: NCT06056830

Age: 18 years - 66+

Gender: Male

Healthy Subjects: No

Study Phase: Phase 3

Recruitment Status: Recruiting

Start Date: December 21, 2023

End Date: December 01, 2025

Contact Information:
Clarity Pharmaceuticals
+61 (0) 2 9209 4037
Summary: The aim for this study is to assess the diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases.
Eligibility:

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.
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