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
- • High-risk or greater PC defined by National Comprehensive Cancer Network Guidelines Version 1.2023
- • Untreated, histologically confirmed adenocarcinoma of the prostate
- • Patients electing to undergo RP with PLND.
Exclusion
- •Any serious medical condition or extenuating circumstance which the investigator feels may interfere with the procedure
- •Patients with known predominant small cell or neuroendocrine PC
Patient Education
Patient Education Not Yet Provided
Publications
Publications Not Yet Provided
Locations
United States