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 Pharmaceuticals

Contacts:

Clarity Pharmaceuticals

clinicaltrials@claritypharmaceuticals.com

+61 (0) 2 9209 4037

Government Study Link:

NCT06056830 - Click here to see study on

ClinicalTrials.gov

Drug Details

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®

COPPER-64

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

XCancer - Omaha

17607 Gold Plaza, Omaha, Nebraska 68130, United States