Clinical Trial · NCT04528199

[18F]FLOR (FC303) PET/CT Imaging in Patients With Prostate Cancer

Overview

The study is an open label, single-arm study designed to evaluate the safety and diagnostic performance of \[18F\]FLOR (FC303) PET/CT imaging to determine the presence or absence of metastatic prostate cancer. .

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Phase

Phase 1

Contacts

Steven Rowe, M.D., Ph.D. (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT04528199

Eligibility

Inclusion

Histologically confirmed adenocarcinoma of the prostate.
Radiologic evidence of local recurrence or new or progressive metastatic disease demonstrated on anatomical imaging (CT, or MRI), or whole-body bone scan within 4 weeks of Day 1.
Screening clinical laboratory values within normal limits or judged not clinically significant by the investigator.
At least 2 weeks must have elapsed between last anti-cancer treatment administration and the imaging day. Imaging day will be scheduled before initiation of new systemic therapy for recurrent and/or progressive metastatic disease

Exclusion

Subjects administered any radioisotope within five physical half-lives prior to study drug injection.
Subjects with any medical condition or other circumstances that, in the opinion of the investigator, compromise obtaining reliable data, achieving study objectives, or completion.