NCT06970847

64Cu-SAR-bisPSMA Positron Emission Tomography: A Phase 3 Study of Participants With Biochemical Recurrence of Prostate Cancer

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: Clarity Pharmaceuticals Ltd · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim for this study is to investigate the ability of 64Cu-SAR-bisPSMA PET/CT to detect recurrence of prostate cancer

Conditions

• Prostate Cancer
• Prostate Cancer Patients With Detectable PSA Following Prostatectomy
• Prostate Cancer Recurrent
• Prostate Cancer Patients Who Have Brachytherapy Seed Implant
• Prostate Cancer Patients Treated by Radiotherapy
• Cryotherapy

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: 2025-05-16
• Primary completion: 2026-12-31
• Completion: 2026-12-31
• First posted: 2025-05-14
• Last updated: 2026-04-09

Locations

28 sites across 2 countries: United States, Australia

Regulatory

• FDA-regulated drug study