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

January 11, 2024 updated by: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

A Phase 1 Study of [18F]FLOR (FC303) PET/CT Imaging in Patients With Prostate Cancer

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. .

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

8

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: [18F]FLOR (FC303)
[18F]FLOR (FC303) PET/CT imaging.
Drug: [18F]FLOR (FC303) Injection
Single dose of 10 ±1 millicurie (mCi) of [18F]FLOR (FC303) injection followed by the PET/CT scan.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of study drug emergent adverse events
Time Frame: Up to 10 days post-study drug dosing
Incidence of study drug emergent adverse events will be assessed.
Up to 10 days post-study drug dosing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Collaborators

FutureChem

Investigators

  • Principal Investigator: Steven Rowe, M.D., Ph.D., Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Actual)

April 21, 2023

Study Completion (Actual)

April 21, 2023

Study Registration Dates

First Submitted

August 24, 2020

First Submitted That Met QC Criteria

August 24, 2020

First Posted (Actual)

August 27, 2020

Study Record Updates

Last Update Posted (Actual)

January 16, 2024

Last Update Submitted That Met QC Criteria

January 11, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • J19145
  • IRB00231620 (Other Identifier: JHM IRB)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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