Study Title
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. CLARIFY
Study Details
Description:
The aim for this study is to assess the diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases.
Sponsor:
Clarity PharmaceuticalsContacts:
Clarity Pharmaceuticalsclinicaltrials@claritypharmaceuticals.com
+61 (0) 2 9209 4037
Government Study Link:
NCT06056830 - Click here to see study onClinicalTrials.gov
Drug Details
64Cu-SAR-bisPSMA
Isotope(s):
- COPPER-64
COPPER-64
Radioisotope: Cu-64
Theranostic Role: PET Imaging
T1/2 (Half-Life): 12.7 Hours
Decay Mode: POSITRON β+, BETA, Electron Capture, GAMMA
Energy: 0.65 MeV, Gamma 511 keV
Range: max 2.5mm, mean 0.7mm
Decay Daughters: Ni64 (Stable), Zn64 (Stable)
Status: FDA Approval: DETECTNET®
Target(s):
- PSMA
Inclusion
- • Untreated, histologically confirmed adenocarcinoma of the prostate
- • Patients electing to undergo RP with PLND.
- • High-risk or greater PC defined by National Comprehensive Cancer Network Guidelines Version 1.2023
Exclusion
- •Patients with known predominant small cell or neuroendocrine PC
- •Any serious medical condition or extenuating circumstance which the investigator feels may interfere with the procedure
Patient Education
Patient Education Not Yet Provided
Publications
Publications Not Yet Provided
Locations
United States
Australia
