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

No longer recruiting at 1 trial location

Overseen By Rehab AbdAllah, MB BCH

Age: 18+

Sex: Male

Trial Phase: Phase 1

Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Disqualifiers: Radioisotope use, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new imaging method to determine if it can safely and accurately detect metastatic prostate cancer, which spreads from the prostate to other body parts. The study uses a special PET/CT scan with an injection called [18F]FLOR (FC303) to identify cancer cells. Men diagnosed with prostate cancer who show signs of recurrence or spread may qualify for this trial. Participants should not have received any recent radiation treatments to ensure accurate results. As a Phase 1 trial, this research focuses on understanding how this new imaging method works in people, offering participants the chance to be among the first to benefit from this innovative approach.

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 prior data suggests that [18F]FLOR (FC303) PET/CT imaging is safe for prostate cancer patients?

Research has shown that [18F]FLOR (FC303) is generally safe and well-tolerated by patients. In earlier studies, patients with advanced prostate cancer used this imaging agent without major problems. The process involves a PET/CT scan, which helps doctors see the cancer more clearly.

Notably, a similar imaging agent, Flotufolastat F 18, has received approval in the USA for prostate cancer imaging. This approval suggests that similar agents have undergone safety checks. While [18F]FLOR (FC303) is still in early trials, current evidence indicates it is safe for imaging prostate cancer. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the [18F]FLOR (FC303) PET/CT imaging for prostate cancer because it offers a new way to visualize cancer that could be more precise than traditional imaging techniques like MRI or CT scans. This treatment involves an innovative radioactive tracer, [18F]FLOR, which specifically targets prostate cancer cells, potentially providing clearer images and better insights into the extent of the disease. This could lead to more accurate staging and treatment planning, allowing doctors to tailor therapies more effectively to individual patients.

What evidence suggests that [18F]FLOR (FC303) PET/CT imaging is effective for diagnosing metastatic prostate cancer?

Research has shown that a new imaging method called \[18F\]FLOR (FC303) PET/CT, which participants in this trial will receive, could help detect prostate cancer. This technique uses a special radioactive substance to highlight cancerous areas in the body. Studies have found that similar imaging methods effectively detect prostate cancer, especially when it has spread. The \[18F\]-labeled PET radioligands target specific markers related to prostate cancer, aiding in the identification of cancerous tissues. While more research is needed to confirm the effectiveness of \[18F\]FLOR (FC303), early signs suggest it could be a useful tool for diagnosing advanced prostate cancer. ^{1 2 5 6 7}

Who Is on the Research Team?

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

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

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

Histologically confirmed adenocarcinoma of the prostate

Screening clinical laboratory values within normal limits or judged not clinically significant by the investigator

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

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: [18F]FLOR (FC303) Experimental Treatment 1 Intervention

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

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+

Published Research Related to This Trial

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Flotufolastat F 18: Diagnostic First Approval. Heo, YA.[2023]

In a study of 56 patients with suspected prostate cancer, the novel radiotracer 18F-DCFPyL demonstrated high sensitivity (90%) and specificity (100%) for detecting prostate cancer, making it a reliable diagnostic tool.

The imaging results showed a strong correlation between the radiotracer uptake (measured by SUVmax and SULmax) and serum PSA levels, indicating that 18F-DCFPyL PET/CT is effective for initial diagnosis and lymph node staging in suspected prostate cancer.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of 18F-DCFPyL PET/CT in patients with suspected prostate cancer. Zhang, T., Yang, S., Lin, L., et al.[2022]

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04528199

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

2. cancer.gov cancer.gov/clinicaltrials/NCI-2021-01720

[18F]FLOR (FC303) PET/CT Scan for the Detection of ... This phase I trial is to find out the best dose and side effects of [18F]FLOR (FC303) in detecting prostate cancer tissue when used with positron emission ...

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8165728/

Diagnostic performance of 18F-fluciclovine PET/CT in ... The overall detection rate of 18F-Fluciclovine PET/CT was 7 of 28 studies (25%). PSAPET > 0.2 ng/mL was associated with higher detection rates in all (33.3 vs ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0969805121005345

Recent advancements in 18F-labeled PSMA targeting PET ... In this review, we will give an overview of these recent advancements of 18 F-labeled PSMA PET radioligands.

5. bmccancer.biomedcentral.com bmccancer.biomedcentral.com/articles/10.1186/s12885-025-14301-x

Synthesizing [18F]PSMA-1007 PET bone images from CT ... [18F]FDG PET/CT scan combined with [18F]PSMA-1007 PET/CT scan is commonly conducted for detecting bone metastases in prostate cancer (PCa).

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10166155/

PSMA-Targeted Radiopharmaceuticals in Prostate Cancer This review summarizes the current and future role of radiopharmaceutical therapies in the management of patients with advanced prostate cancer.

7. withpower.com withpower.com/trial/phase-1-prostatic-neoplasms-1-2021-0cc50

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