Back to results[18F]FLOR (FC303) PET/CT Imaging in Patients With Prostate Cancer
Primary Purpose
Metastatic Prostate Cancer
Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
[18F]FLOR (FC303) Injection
Sponsored by
About this trial
This is an interventional diagnostic trial for Metastatic Prostate Cancer focused on measuring [18F]FLOR, PET/CT, prostate cancer, J19145
Eligibility Criteria
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.
Sites / Locations
- Johns Hopkins University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
[18F]FLOR (FC303)
Arm Description
[18F]FLOR (FC303) PET/CT imaging.
Outcomes
Primary Outcome Measures
Incidence of study drug emergent adverse events
Incidence of study drug emergent adverse events will be assessed.
Secondary Outcome Measures
Full Information
NCT ID
NCT04528199
First Posted
August 24, 2020
Last Updated
January 9, 2023
Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
FutureChem
1. Study Identification
Unique Protocol Identification Number
NCT04528199
Brief Title
[18F]FLOR (FC303) PET/CT Imaging in Patients With Prostate Cancer
Official Title
A Phase 1 Study of [18F]FLOR (FC303) PET/CT Imaging in Patients With Prostate Cancer
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 1, 2021 (Actual)
Primary Completion Date
December 1, 2025 (Anticipated)
Study Completion Date
December 1, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Collaborators
FutureChem
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Prostate Cancer
Keywords
[18F]FLOR, PET/CT, prostate cancer, J19145
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
[18F]FLOR (FC303)
Arm Type
Experimental
Arm Description
[18F]FLOR (FC303) PET/CT imaging.
Intervention Type
Drug
Intervention Name(s)
[18F]FLOR (FC303) Injection
Intervention Description
Single dose of 10 ±1 millicurie (mCi) of [18F]FLOR (FC303) injection followed by the PET/CT scan.
Primary Outcome Measure Information:
Title
Incidence of study drug emergent adverse events
Description
Incidence of study drug emergent adverse events will be assessed.
Time Frame
Up to 10 days post-study drug dosing
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Rowe, M.D., Ph.D.
Organizational Affiliation
Johns Hopkins University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
12. IPD Sharing Statement
Learn more about this trial
[18F]FLOR (FC303) PET/CT Imaging in Patients With Prostate Cancer
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