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Clinical Trial · NCT05407311
64Cu-SAR-BBN Positron Emission Tomography: A Phase 2 Study of Participants With PSMA-negative Biochemical Recurrence of Prostate Cancer.
Overview
The aim of this study is to determine the safety and efficacy of 64Cu-SAR-BBN and determine the ability of 64Cu-SAR-BBN Positron emission tomography (PET)/computed tomography (CT) to correctly detect the recurrence of prostate cancer in participants with PSMA-negative biochemical recurrence of prostate cancer following definitive therapy.
Sponsor
Clarity PharmaceuticalsPhase
Phase 2
Contacts
Clarity Pharmaceuticals (Clarity Clinical)
clinicaltrials@claritypharmaceuticals.com
+61 0 2 9209 4037
ClinicalTrials.gov
NCT05407311Drug / Compound
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):
Eligibility
Inclusion
- • Histologically confirmed adenocarcinoma of prostate per original diagnosis and completed subsequent definitive therapy
- • Negative or equivocal findings for PC
- • Adequate liver function
- • Estimated Glomerular Filtration Rate of 30 mL/min or higher.
- • Suspected recurrence of prostate cancer (PC) based on rising Prostate specific antigen (PSA) after definitive therapy
Exclusion
- •Any serious medical condition or extenuating circumstance which the investigator feels may interfere with the procedure
- • Ongoing treatment or treatment within 90 days of Day 0 with any systemic therapy
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