NCT04839367

Positron Emission Tomography (PET) Imaging of Participants With Confirmed Prostate Cancer Using 64Cu-SAR-bisPSMA (PROPELLER)

Positron Emission Tomography Imaging of Participants With Confirmed Prostate Cancer Using 64Cu-SAR-bisPSMA: A Multi-Centre, Blinded Review, Dose Ranging Phase I Study

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 30 (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 tolerability of 64Cu-SARbisPSMA in participants with untreated, confirmed Prostate Cancer.

Detailed description

This is a multi-centre, blinded review, dose ranging, non-randomized study of 64Cu-SAR-bisPSMA administered to participants with confirmed Prostate Cancer. 30 eligible participants will be allocated (1:1:3) to 1 of 3 dosing cohorts to be administered with 64Cu-SAR-bisPSMA 100 MBq, 150 MBq or 200 MBq. PET/CT scan images will be sent to blinded central readers to assess the capacity of 64Cu-SAR-bisPSMA to detect primary Prostate Cancer, to assess image quality of the various dose cohorts, and to assess the PET/CT scan features of 64Cu-SAR-bisPSMA in comparison standard of care.

Conditions

• Prostatic Neoplasms

Interventions

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

Timeline

• Start date: 2021-07-13
• Primary completion: 2022-10-19
• Completion: 2022-10-19
• First posted: 2021-04-09
• Last updated: 2023-01-17

Locations

3 sites across 1 country: Australia