NCT06056830

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

Positron Emission Tomography Using 64Cu-SAR-bisPSMA in Participants With High-risk Prostate Cancer Prior to Radical Prostatectomy: A Prospective, Single-arm, Multi-center, Blinded-review, Phase 3 Diagnostic Performance Study

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 383 (estimated)
• Sponsor: Clarity Pharmaceuticals Ltd · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Prostate Cancer
• Prostatic Neoplasms

Interventions

Type	Name	Description
DRUG	64Cu-SAR-bisPSMA	All Patients will receive a single administration, a bolus injection of 200MBq 64Cu-SAR-bisPSMA.

Timeline

• Start date: 2023-12-21
• Primary completion: 2026-09-01
• Completion: 2026-09-01
• First posted: 2023-09-28
• Last updated: 2026-04-09

Locations

27 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study