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Clinical Trial · NCT06056830
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
Overview
The aim for this study is to assess the diagnostic performance of 64Cu-SAR-bisPSMA PET to detect regional nodal metastases.
Sponsor
Clarity PharmaceuticalsPhase
Phase 3
Contacts
Clarity Pharmaceuticals
clinicaltrials@claritypharmaceuticals.com
+61 (0) 2 9209 4037
ClinicalTrials.gov
NCT06056830Drug / Compound
64Cu-SAR-bisPSMA
Isotope(s):
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
Educational Video
Eligibility
Inclusion
- • Patients electing to undergo RP with PLND.
- • Untreated, histologically confirmed adenocarcinoma of the prostate
- • 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.
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