Axumin PET/CT Scans in Men with Suspected Recurrent Prostate Cancer May Change Treatment Plans

Axumin PET/CT Scans in Men with Suspected Recurrent Prostate Cancer May Change Treatment Plans

More than six out of 10 men whose doctors suspected their prostate cancer had returned due to rising prostate specific antigen (PSA) levels saw their treatment plans revised after being submitted to PET/CT imaging with Axumin (18F-fluciclovine).

That’s according to the Phase 3 FALCON trial (NCT02578940), whose findings were recently presented at the 2017 American Society for Radiology Oncology (ASTRO) Annual Meeting in San Diego.

The oral presentation, “Impact of 18F-fluciclovine PET/CT on clinical management of patients with recurrent prostate cancer: results from the Phase III FALCON trial,” reported that early and accurate localization of metastasis facilitates treatment, as the tumors are smaller in size and respond better to localized therapy.

Axumin, a 18F-fluciclovine injection, is a molecular agent used in positron emission tomography (PET) imaging in men with suspected recurrent prostate cancer. The suspicion is supported by high levels of PSA in the blood, following prior treatment. The U.S. Food and Drug Administration (FDA) has approved this injection for use in PET imaging, but not for treatment planning in men with biochemically recurrent prostate cancer.

With this in mind, researchers aimed to assess the impact of PET/CT imaging with Axumin on clinical management choices for men with recurrent prostate cancer.

The FALCON trial, sponsored by Blue Earth Diagnostics, was a British-based, prospective, multi center and open-label study testing the addition of Axumin PET/CT imaging to standard diagnostic techniques.

Researchers recruited men with recurrent prostate cancer being considered for curative intent salvage therapy. The team then compared their intended management plans, before and after Axumin PET/CT scan.

In a pre-planned analysis of the first 85 patients, researchers found that 52 men, or 61.2 percent, had their clinical management changed after the Axumin PET/CT imaging results were added to the diagnostic work-up.

Among those 52 men, 13 (or 25 percent) changed from salvage treatment to watchful waiting, 18 (or 34.6 percent) had their salvage treatment revised to systemic therapy, and 21 (or 40.4 percent) had their previously planned radiotherapy field modified.

Thanks to its successful results, Blue Earth Diagnostics has announced a halt to patient recruitment.

“In line with our mission to develop and commercialize innovative PET imaging agents for cancer, the FALCON study was designed to assess the utility of a fluciclovine (18F) PET/CT scan in providing meaningful information for physicians, with the hope that it may benefit men with recurrent prostate cancer,” Jonathan Allis, CEO of Blue Earth, said in a press release. “We look forward to announcing full results of the FALCON study in a future peer-reviewed publication.”

Added Abhishek Solanki, assistant professor of radiation oncology at Chicago’s Loyola University: “Currently approved anatomical imaging procedures have limitations in identifying the sites of recurrence of prostate cancer after definitive treatment, which can make decision-making difficult when assessing patients with biochemical recurrence. Newer imaging techniques, such as fluciclovine (18F) PET/CT, may provide actionable information for physicians in guiding appropriate patient management.”


  1. Lawrence Glickman says:

    More “Watchful Waiting”?? This is a nice advancement in technology but I just wonder how many of these patients have a recurrence because they were led into “Watchful Waiting” to begin with and lost the opportunity for an early complete cure.

  2. Stephen B. Strum, MD, FACP says:

    Advances in imaging of cancer are critical to avoid both under- and over-treatments. However, it is imperative that not only do we confirm that an imaging “advance” leads to changes in “choices” but that the choices made are the correct ones by focusing on the follow-up of “outcomes”. As a student of prostate cancer and keenly interested in imaging of this disease, I have found that the advances in PET/CT are often not evaluated in head-to-head studies with other staging modalities such as MRI; or with other PET/CT studies employing different isotopes. So as a clinician I am left wondering, is NaF PET/CT better, equal or worse than Axumin PET-CT and is 68Ga-PSMA PET/CT better, equal or worse than another PET isotope. Is Axumin PET-CT as goos as multi-parametric MRI (mp-MRI) in assessing the prostate gland? Physicians and their centers are NOT answering these questions, and when rarely they are answered (e.g., NaF PET/CT is far more accurate than Tc99 bone scanning) the results do not translate into the care of the patient as seen by what is being done even in the so-called “academic” centers who still use imaging that is poorly sensitive such as Tc99 and CT scanning of the abdomen and pelvis. The cost to the system and the patient amounts to billions of dollars of healthcare dollars annually (i.e., the cost of inferior testing and the effects of suboptimal outcomes of treatment on millions of lives).
    We simply just are not doing our due diligence.

    • Daniel Gordon says:

      We have a large experience with MRI and utilizing PIRADS 2 guidelines have significantly influenced management in our are of NC

  3. This is true that any kind of cancer is hard to diagnose, its patients usually leave hopes. But what I believe is, hard to diagnose does not mean impossible, various types of scans are available these days to sort out the exact cause from the roots such as MRI. And when we have roots, then we can also cut them.

  4. John Norris M D says:

    If a patient is receiving Eliguard, completed prostate radiation 15 months ago, has a Gleason score of 9, has a PSA of <.02% and has 1 suspected met at L1 is an Axunim PET scan of value

  5. Tom Trivento says:

    I had a prostectomy on July 10, 2018 due to a Gleason Score of 8+. The surgeon indicated during surgery he noticed the cancer had gone outside the prostate gland. (6) weeks after surgery my PSA came back at 2.5 and an Axumin test was taken from skull to thigh. The results showed ”nothing lit up” on the test, but we are still going ahead with hormone shots and radiation. What happened to my cancer? Your opinion would be greatly valued. Tom

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