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

• Status: Recruiting
• Trial end date: 2025-02-01
• Target enrollment: 0
• Participant gender: Male

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clarity Pharmaceuticals Ltd

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.