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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Metastatic Prostate Cancer

Intervention / Treatment
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* Drug: [18F]FLOR (FC303) Injection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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[18F]FLOR, PET/CT, prostate cancer, J19145