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Clinical Trial · NCT06617481
PET Scan Study to Detect Prostate Cancer in Patients with Early PSA Recurrence
Overview
Flotufolastat F-18, sold under the brand name Posluma, is a radioactive diagnostic agent for use with positron emission tomography (PET) imaging for prostate cancer. The research is being done to study the capability of 18F-rhPSMA-7.3 (flotufolastat F-18) PET scan to detect prostate cancer when there are very low levels of Prostate-Specific Antigen (PSA) following previous radical prostatectomy surgery.
Sponsor
AdventHealth
Phase
Phase 2
Contacts
AdventHealth AdventHealth Oncology Research (CONTACT)
cfd.researchoncology@adventhealth.com
407-303-2090
ClinicalTrials.gov
NCT06617481Drug / Compound
rhPSMA-7.3
Isotope(s):
FLUORINE-18
Radioisotope: F-18
Theranostic Role: PET Imaging
T1/2 (Half-Life): 1.8 Hours
Decay Mode: POSITRON β+ (96.7%), ELECTRON CAPTURE (3.3%), GAMMA 511 keV
Energy: Eβ+ 635 keV
Range: N/A
Decay Daughters: O18 (Stable)
Status: FDA Approvals: FDG (Cancer 2005): GLUDEF®, METATRACE® AXUMIN® (2016), PYLARIFY® (2023), POSLUMA® (2024)
Target(s):
- PSMA
Ligand Class: Small Molecules
Eligibility
Inclusion
- History of localized adenocarcinoma of the prostate with prior curative intent radical prostatectomy.
- An elevated PSA test result that is greater than or equal to 0.1 ng/ml and less than 0.5
Exclusion
- Patients who are planned to have an x-ray contrast agent or other PET radiotracer \& less than 24 hours prior to the flotufolastat F-18 PSMA-PET scan.
- Patients currently receiving Androgen Deprivation Therapy (ADT).
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