NCT05407311

64Cu-SAR-BBN for Identification of Participants With Recurrence of Prostate Cancer (SABRE)

64Cu-SAR-BBN Positron Emission Tomography: A Phase 2 Study of Participants With PSMA-negative Biochemical Recurrence of Prostate Cancer

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Clarity Pharmaceuticals Ltd · Industry
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The aim of this study is to determine the safety and efficacy of 64Cu-SAR-BBN and determine the ability of 64Cu-SAR-BBN Positron emission tomography (PET)/computed tomography (CT) to correctly detect the recurrence of prostate cancer in participants with prostate-specific membrane antigen (PSMA)-negative biochemical recurrence of prostate cancer following definitive therapy.

Detailed description

Participants with biochemical evidence of recurrence of prostate cancer (PC) were evaluated with 64Cu-SAR-BBN PET/CT (Day 0 and Day 1) and by conventional methodologies up to 180 days later (e.g., histopathology/biopsy, conventional imaging, prostate specific antigen \[PSA\] reduction post focal salvage therapy or radiotherapy with no concomitant androgen deprivation therapy). Three independent, central readers blinded to the participant number, the time of the PET/CT scan, and the results of the conventional methodologies, assessed the 64Cu-SAR-BBN PET/CT. Three separate independent readers assessed the results of the conventional methodologies.

Conditions

• Biochemical Recurrence of Malignant Neoplasm of Prostate

Interventions

Type	Name	Description
DRUG	64Cu-SAR-BBN	64Cu-SAR-BBN

Timeline

• Start date: 2022-09-19
• Primary completion: 2024-05-13
• Completion: 2024-05-13
• First posted: 2022-06-07
• Last updated: 2025-11-17
• Results posted: 2025-11-17

Locations

8 sites across 1 country: United States

Regulatory

• FDA-regulated drug study