142 Participants NeededMy employer runs this trial

Fluciclovine PET for Prostate Cancer

Recruiting at 5 trial locations
BS
LD
Overseen ByLauren Dean
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a fluciclovine (18F) PET scan can aid in managing prostate cancer that has returned after previous treatments were insufficient. It focuses on men with prostate cancer and rising PSA levels (a protein marker in the blood) following surgery or radiation, who received unclear results from another type of PET scan. The trial includes a single PET scan using fluciclovine (18F) to gain a clearer understanding of the cancer's status. Men with a negative or unclear recent PSMA PET scan, facing recurrent prostate cancer, might be suitable candidates. As a Phase 4 trial, this research involves an FDA-approved treatment and aims to determine its benefits for a broader patient population.

Do I have to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, you should not start any new cancer treatments or supplements between the PSMA PET and fluciclovine PET/CT scans.

What is the safety track record for fluciclovine (18F)?

Previous studies have shown that fluciclovine (18F), also known as Axumin, is safe for patients with prostate cancer. The FDA has approved it for detecting recurrent prostate cancer. Research indicates that side effects are usually mild, such as pain or redness at the injection site. These reactions are common and typically resolve quickly. While Axumin does increase radiation exposure over time, this is standard with PET scans. Overall, past data supports its safety for imaging prostate cancer.12345

Why are researchers enthusiastic about this study treatment?

Fluciclovine (18F) is unique because it enhances imaging for prostate cancer by using a radioactive tracer that targets amino acid transporters, which are often more active in cancer cells. Traditional imaging techniques for prostate cancer, like bone scans or CT, often miss small or hidden tumors. Fluciclovine (18F) PET scans offer more precise and earlier detection, potentially leading to better treatment planning and outcomes. Researchers are excited about this because it could significantly improve how prostate cancer is monitored and managed, especially in cases where the cancer is hard to locate with standard imaging methods.

What evidence suggests that fluciclovine (18F) PET is effective for prostate cancer?

Research has shown that 18F-fluciclovine PET scans can significantly aid in managing prostate cancer. Studies have found that this imaging method altered treatment plans for 62% of patients with recurrent prostate cancer. It also detected cancer recurrence in 37.9% of patients, outperforming some other imaging methods. In another study, these scans improved event-free survival rates, helping patients stay healthy longer. This trial will involve a single intravenous administration of fluciclovine (18F) for a PET scan, indicating that 18F-fluciclovine PET is a powerful tool for detecting and managing prostate cancer.25678

Who Is on the Research Team?

NM

Nadine Mallak, MD

Principal Investigator

Oregon Health and Science University

Are You a Good Fit for This Trial?

This trial is for men aged 18 or older who have had prostate cancer treated with the intent to cure, but now show signs of recurrence based on rising PSA levels. They must have recently had a negative or unclear PSMA PET scan and be able to follow study procedures.

Inclusion Criteria

I am a male and at least 18 years old.
6. Ability of the participants to comply with planned study procedures
5. Participants must provide written informed consent before any study-specific procedures or interventions are performed.
See 3 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging

Participants receive a single intravenous administration of fluciclovine (18F) for PET Scan

1 day
1 visit (in-person)

Follow-up

Participants are monitored for changes in management following the imaging procedure

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • Fluciclovine (18F)

Trial Overview

The study is testing whether using fluciclovine (18F) PET scans can help guide treatment decisions in men whose prostate cancer may have returned after previous treatment and who had inconclusive results from a prior PSMA PET scan.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: Patients Single intravenous administration of fluciclovine (18F) for PET ScanExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Blue Earth Diagnostics

Lead Sponsor

Trials
43
Recruited
3,100+

Citations

Update on 18F-Fluciclovine PET for Prostate Cancer Imaging

In another analysis from this trial, use of 18F-fluciclovine PET changed the planning volumes for 83% of lesions without a change in toxicity ( ...

Real-World data show utility of 18F-fluciclovine PET/CT in ...

Use of 18 F-fluciclovine (Axumin) PET/CT changed clinical management in 62% of patients with biochemically recurrent prostate cancer, according to real-world ...

18 F-Fluciclovine PET/CT performance in biochemical ...

Outcome data from the study reported the 3-year failure-free survival (FFS) of those undergoing 18F-fluciclovine PET/CT to be 75.5% compared ...

Implications on Radiation Treatment Planning of 18F ...

The results revealed that 18F-fluciclovine was positive in 57.1% of patients, identifying local recurrence in 50%, regional metastases in 18%, and distant ...

Axumin® (fluciclovine F 18) PET Imaging in men with ...

The randomized, prospective study showed that Axumin-guided post-prostatectomy radiation therapy increased biochemical event-free survival rates ...

AXUMIN (fluciclovine F 18) injection, for intravenous use

The safety and efficacy of Axumin were evaluated in two studies (Study 1 and Study 2) in men with suspected recurrence of prostate cancer based on rising PSA ...

7.

axumin.com

axumin.com/

Official Axumin® (fluciclovine F 18) injection Website | For ...

Axumin use contributes to a patient's overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling ...

18F-Fluciclovine [Axumin®] PET/CT Scan

In prostate cancer cells, the need for amino acids is elevated. Therefore, the uptake of 18F-Fluciclovine will be high in prostate cancer cells and low in ...