What side effects are associated with this type of intervention?

Common treatments for prostate cancer, particularly those involving radiotracers and imaging techniques like [18F]FLOR (FC303) PET/CT, often include androgen deprivation therapy (ADT) and chemotherapy. ADT can lead to side effects such as hot flashes, reduced libido, fatigue, and osteoporosis. Chemotherapy, often used for advanced stages, can cause nausea, hair loss, fatigue, and increased risk of infections. Radiotracer-based imaging itself is generally well-tolerated, but may occasionally cause mild allergic reactions or discomfort at the injection site.

What prior FDA approvals exist?

The FDA has approved several radiotracers for PET/CT imaging in prostate cancer. Notably, [18F]-Fluciclovine and [68Ga]-PSMA-11 are used for detecting recurrent disease and staging. [18F]-DCFPyL, another PSMA-targeted radiotracer, has also been approved for similar purposes. These agents help visualize metastatic prostate cancer by binding to specific markers on cancer cells, aiding in precise imaging and treatment planning.

What other types of research exist?

Promising alternatives to [18F]FLOR (FC303) PET/CT imaging for prostate cancer patients include: 1) [18F]-fluoroacetate ([18F]-FAC), which has a longer half-life and is being evaluated for prostate tumor imaging. 2) [18F]-AlF-NOTA-AE105, a PET ligand targeting the urokinase-type plasminogen activator receptor (uPAR), which is overexpressed in prostate cancer and associated with metastatic disease. 3) [18F]-FLT, which has shown potential for monitoring therapeutic responses in prostate cancer, particularly in detecting changes in tumor proliferation.

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[18F]FLOR PET/CT Imaging for Prostate Cancer

Phase 1

Waitlist Available

Led By Steven Rowe, M.D., Ph.D.

Research Sponsored by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 10 days post-study drug dosing

Awards & highlights

Summary

This trial is testing a special scan that uses a radioactive dye to detect cancer spread in patients with metastatic prostate cancer. The dye helps highlight cancer cells during the scan, making it easier for doctors to see where the cancer is located.

Who is the study for?

This trial is for men over 18 with confirmed adenocarcinoma of the prostate who have signs of recurring or spreading cancer. They must not have had cancer treatment in the last 2 weeks and should be able to follow study procedures. Men who've recently received radioisotopes or have conditions that may skew results can't participate.

What is being tested?

[18F]FLOR (FC303) PET/CT imaging is being tested for its safety and ability to detect metastatic prostate cancer. Participants will receive an injection of [18F]FLOR, followed by a PET/CT scan to identify if their cancer has spread.

What are the potential side effects?

While specific side effects are not listed, participants will be monitored for any adverse reactions following the injection of [18F]FLOR (FC303), which could range from mild allergic reactions to more serious complications.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 10 days post-study drug dosing

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 10 days post-study drug dosing

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 10 days post-study drug dosing for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of study drug emergent adverse events

Trial Design

1Treatment groups

Experimental Treatment

Group I: [18F]FLOR (FC303)Experimental Treatment1 Intervention

\[18F\]FLOR (FC303) PET/CT imaging.

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for prostate cancer include androgen deprivation therapy (ADT), chemotherapy, and radiopharmaceuticals. ADT works by reducing androgen levels, which prostate cancer cells rely on for growth. Chemotherapy targets and kills rapidly dividing cancer cells. Radiopharmaceuticals, such as [18F]FLOR used in PET/CT imaging, bind to cancer cells, allowing for precise visualization and targeted radiation therapy. These mechanisms are crucial for tailoring treatment plans to effectively manage and treat prostate cancer, improving patient outcomes by addressing the specific behavior and spread of the cancer.

[18F]DCFPyL PET-MRI/CT for unveiling a molecularly defined oligorecurrent prostate cancer state amenable for curative-intent ablative therapy: study protocol for a phase II trial.Exploratory study of 18F-fluciclovine pet/ct for response assessment to docetaxel in patients with metastatic castration-resistant prostate cancer.Randomized prospective phase III trial of 68Ga-PSMA-11 PET/CT molecular imaging for prostate cancer salvage radiotherapy planning [PSMA-SRT].

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Who is running the clinical trial?

Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLead Sponsor

566 Previous Clinical Trials

33,368 Total Patients Enrolled

58 Trials studying Prostate Cancer

3,428 Patients Enrolled for Prostate Cancer

FutureChemIndustry Sponsor

5 Previous Clinical Trials

563 Total Patients Enrolled

Steven Rowe, M.D., Ph.D.Principal InvestigatorJohns Hopkins University

1 Previous Clinical Trials

23 Total Patients Enrolled

1 Trials studying Prostate Cancer

23 Patients Enrolled for Prostate Cancer

Media Library

[18F]FLOR (FC303) Injection Clinical Trial Eligibility Overview. Trial Name: NCT04528199 — Phase 1

Prostate Cancer Research Study Groups: [18F]FLOR (FC303)

Prostate Cancer Clinical Trial 2023: [18F]FLOR (FC303) Injection Highlights & Side Effects. Trial Name: NCT04528199 — Phase 1

[18F]FLOR (FC303) Injection 2023 Treatment Timeline for Medical Study. Trial Name: NCT04528199 — Phase 1

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