8 Participants Needed

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

Recruiting at 1 trial location
MK
RA
Overseen ByRehab AbdAllah, MB BCH
Age: 18+
Sex: Male
Trial Phase: Phase 1
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Will I have to stop taking my current medications?

The trial requires that at least 2 weeks have passed since your last anti-cancer treatment before the imaging day. It doesn't specify about other medications, so it's best to discuss with the study team.

What data supports the effectiveness of the drug [18F]FLOR (FC303) Injection for prostate cancer?

The research on a similar imaging agent, 18F-DCFPyL PET/CT, shows it can improve the detection of prostate cancer and influence treatment decisions, suggesting that [18F]FLOR (FC303) Injection might also be effective in identifying prostate cancer and guiding treatment.12345

Is [18F]FLOR PET/CT Imaging for Prostate Cancer safe for humans?

Flotufolastat F 18, a similar imaging agent, was approved in the USA in May 2023 for prostate cancer imaging, indicating it has been evaluated for safety in humans. While specific safety data for [18F]FLOR is not detailed, the approval of similar agents suggests a level of safety in human use.678910

How is [18F]FLOR PET/CT Imaging different from other treatments for prostate cancer?

[18F]FLOR PET/CT Imaging is unique because it uses a specific radiotracer for PET/CT scans to detect prostate cancer, potentially offering more precise imaging compared to traditional methods. This can help in identifying the cancer's location and extent more accurately, which is crucial for planning effective treatment.358911

Research Team

SR

Steven Rowe, M.D., Ph.D.

Principal Investigator

Johns Hopkins University

Eligibility Criteria

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.

Inclusion Criteria

Males ≥18 years of age
Histologically confirmed adenocarcinoma of the prostate
Screening clinical laboratory values within normal limits or judged not clinically significant by the investigator
See 3 more

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

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Imaging

Participants undergo [18F]FLOR (FC303) PET/CT imaging to assess the presence of metastatic prostate cancer

1 day
1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after imaging

10 days

Treatment Details

Interventions

  • [18F]FLOR (FC303) Injection
Trial Overview[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.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: [18F]FLOR (FC303)Experimental Treatment1 Intervention
\[18F\]FLOR (FC303) PET/CT imaging.

Find a Clinic Near You

Who Is Running the Clinical Trial?

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Lead Sponsor

Trials
578
Recruited
33,600+

FutureChem

Industry Sponsor

Trials
6
Recruited
620+

Findings from Research

The novel PSMA-targeted PET radiotracer [(18)F]DCFPyL detected 139 sites of metastatic prostate cancer in patients, significantly outperforming conventional imaging modalities (CIM), which only identified 45 lesions.
This study suggests that [(18)F]DCFPyL PET imaging is more effective in identifying metastatic disease, especially in cases where CIM results were negative or equivocal, highlighting its potential as a superior diagnostic tool for prostate cancer.
PSMA-Based [(18)F]DCFPyL PET/CT Is Superior to Conventional Imaging for Lesion Detection in Patients with Metastatic Prostate Cancer.Rowe, SP., Macura, KJ., Mena, E., et al.[2022]
In a study of 253 patients with biochemically recurrent hormone-sensitive prostate cancer, 40.7% had a change in treatment management after undergoing 18F-DCFPyL PET/CT imaging, highlighting its significant impact on clinical decision-making.
Positive findings from the 18F-DCFPyL PET/CT scan and positive pathological lymph node status were strong predictors for changing treatment plans, while a positive surgical margin was associated with a lower likelihood of management change.
Management impact of 18F-DCFPyL PET/CT in hormone-sensitive prostate cancer patients with biochemical recurrence after definitive treatment: a multicenter retrospective study.Meijer, D., van Leeuwen, PJ., Oosterholt, PMJ., et al.[2021]
Flotufolastat F 18 (POSLUMA®) is a newly approved imaging agent specifically designed for detecting prostate cancer lesions using PET scans, particularly in men with suspected metastasis or recurrence.
The approval in May 2023 marks a significant milestone in prostate cancer diagnostics, allowing for better identification of PSMA positive lesions in patients who are candidates for definitive therapy.
Flotufolastat F 18: Diagnostic First Approval.Heo, YA.[2023]

References

The Impact of 18F-DCFPyL PET-CT Imaging on Initial Staging, Radiation, and Systemic Therapy Treatment Recommendations for Veterans With Aggressive Prostate Cancer. [2022]
PSMA-Based [(18)F]DCFPyL PET/CT Is Superior to Conventional Imaging for Lesion Detection in Patients with Metastatic Prostate Cancer. [2022]
Detection of recurrent prostate cancer with 18F-fluorocholine PET/CT in relation to PSA level at the time of imaging. [2021]
PSMA-based 18F-DCFPyL PET: a better choice than multiparametric MRI for prostate cancer diagnosis? [2023]
Management impact of 18F-DCFPyL PET/CT in hormone-sensitive prostate cancer patients with biochemical recurrence after definitive treatment: a multicenter retrospective study. [2021]
The Performance of FDA-Approved PET Imaging Agents in the Detection of Prostate Cancer. [2022]
Flotufolastat F 18: Diagnostic First Approval. [2023]
BAY 1075553 PET-CT for Staging and Restaging Prostate Cancer Patients: Comparison with [18F] Fluorocholine PET-CT (Phase I Study). [2021]
Recent updates and developments in PET imaging of prostate cancer. [2021]
Role of 18F-DCFPyL PET/CT in patients with suspected prostate cancer. [2022]
Combined 18F-fluorocholine and 18F-fluoride positron emission tomography/computed tomography imaging for staging of high-risk prostate cancer. [2022]