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COBRA: 64Cu-SAR-bisPSMA PET/CT in Biochemical Recurrence of Prostate Cancer

NCT05249127Phase 2

Key facts

Status: Completed
Start: Apr 2022
Primary completion: Aug 2023
Countries: 1
Sponsor: Clarity Pharmaceuticals
Modality: Peptide-Drug Conjugates

Drugs: 64Cu-SAR-bisPSMA
Conditions: prostate cancer (PCa)

Overview

Phase 2, open-label, single-arm trial of 64Cu-SAR-bisPSMA in prostate cancer (PCa), sponsored by Clarity Pharmaceuticals. Primary endpoints: Safety and Tolerability, Participant-level Correct Detection Rate Day 0 and 3 more. Started Apr 2022; status: completed.

Design

1 arm

Study design: Non-randomizedOpen-labelSingle group

64Cu-SAR-bisPSMA
Single dose of 64Cu-SAR-bisPSMA followed by PET/CT imaging

Endpoints

Primary

Safety and Tolerabilityup to 7 days post injection
Participant-level Correct Detection Rate Day 0Day 0
Participant-level Correct Detection Rate Day 1Day 1
Region-level Positive Predictive Value Day 0Day 0
Region-level Positive Predictive Value Day 1Day 1

Secondary

Biodistribution of 64Cu-SAR-bisPSMA - SUVmeanDay 1
Biodistribution of 64Cu-SAR-bisPSMA - SUVmaxDay 1

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