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

Phase 1

Terminated

• Conditions: Metastatic Prostate Cancer
• Interventions: Drug: [18F]FLOR (FC303) Injection

• Registration Number: NCT04528199
• Lead Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Brief Summary

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. .

Detailed Description

This research is being done to determine whether the radioactive compound called \[18F\]FLOR (FC303) is safe and well-tolerated in patients with metastatic prostate cancer.

Participants in this study will have tests, exams and procedures that are for study purposes. Participants will be in this study up to one month which will include up to three clinic visits.

Eligible patients diagnosed with metastatic prostate cancer will undergo a \[18F\]FLOR (FC303) PET-CT scan. This is the imaging procedure to assess where \[18F\]FLOR (FC303) has accumulated in the body.

Study Timeline

• Study First Submitted: 2020-08-24
• Study First Submitted QC: 2020-08-24
• Study First Posted: 2020-08-27
• Study Start: 2021-02-01
• Primary Completion: 2023-04-21
• Study Completion: 2023-04-21
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-11
• Last Update Posted: 2024-01-16

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Male
• Target Recruitment: 8

Inclusion Criteria

• Males ≥18 years of age.
• Subjects provide signed informed consent and confirm that they are able and willing to comply with all protocol requirements.
• 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.
• 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
• Screening clinical laboratory values within normal limits or judged not clinically significant by the investigator.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
[18F]FLOR (FC303)	[18F]FLOR (FC303) Injection	\[18F\]FLOR (FC303) PET/CT imaging.

Primary Outcome Measures

Name	Time	Method
Incidence of study drug emergent adverse events	Up to 10 days post-study drug dosing	Incidence of study drug emergent adverse events will be assessed.

Trial Locations

Locations (1)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States