BOSTON, Sept. 22, 2026 /PRNewswire/ — Blue Earth Diagnostics, part of the Bracco Group and recognized leader in the development and commercialization of innovative positron emission tomography (PET) radiopharmaceuticals, today announced new research examining how precision molecular imaging may provide clinically meaningful insights in cancer care when conventional measures or imaging alone may leave uncertainty about the location or extent of disease. The data, spanning recurrent prostate cancer and brain metastases, will be presented at the upcoming American Society for Radiation Oncology (ASTRO) 2026 Annual Meeting, September 26–30, in Boston, MA.

The presentations highlight two distinct clinical settings in which clinicians may face uncertainty. In recurrent prostate cancer, rising prostate-specific antigen (PSA) levels may indicate cancer has returned without showing where it is located. The first presentation showcases an analysis from the first intra-patient, head-to-head comparator study of POSLUMA^® (flotufolastat F 18) and piflufolastat F 18, examining detection rates in men with biochemical recurrence. For patients with brain metastases, the second study evaluated fluciclovine F 18 PET/CT alongside magnetic resonance imaging (MRI) following surgery, when post-operative changes can make it difficult to distinguish treatment-related changes from tumor necrosis or pseudoprogression.

Previously presented results from the head-to-head study, including data shared at the Society of Nuclear Medicine and Molecular Imaging (SNMMI) 2026 Annual Meeting, showed significantly lower urinary radioactivity with POSLUMA compared with piflufolastat F 18. Lower urinary activity may mean less interference when looking for recurrent disease, particularly at very low PSA levels.

At ASTRO 2026, the new analysis explores how clinical factors may influence detection with POSLUMA and piflufolastat F 18 in men with biochemical recurrence and low PSA levels (≤0.5 ng/mL) following radical prostatectomy. Factors include baseline PSA level, time since radical prostatectomy, initial disease stage and International Society of Urological Pathology (ISUP) Grade Group.

“Biochemical recurrence after radical prostatectomy presents an important clinical challenge because a rising PSA level can signal recurrent disease without identifying where it is located,” said Jack R. Andrews, M.D., Urologic Oncologist and Assistant Professor of Urology, Mayo Clinic. “This first head-to-head PSMA PET trial allows us to compare two PSMA PET imaging agents in the same patients and better understand how clinical factors may affect detection rates, particularly at low PSA levels. These insights can help inform how molecular imaging is used in the evaluation of patients with biochemically recurrent prostate cancer.”

The brain metastases presentation draws from a prospective, single-institution trial evaluating fluciclovine F 18 PET/CT in adults undergoing resection followed by post-operative fractionated stereotactic radiosurgery. The study examined whether PET imaging alongside MRI can provide additional information to assess the extent of resection, refine target volume delineation – defining the area to be treated with radiation – and monitor for signs of recurrence over time.

“In multidisciplinary cancer care, connecting the right imaging insights with the treatment decisions that follow is critical,” said Marco Campione, President and CEO of Blue Earth Diagnostics. “Our presence at ASTRO 2026 reflects our continued commitment to advancing the field of precision molecular imaging through focused science and clinical research. From identifying suspected recurrent prostate cancer when PSA levels are low to exploring how PET imaging may help better define and monitor brain metastases following surgery, this research builds on our experience in molecular imaging while helping expand what these technologies can reveal to inform patient care.”

Blue Earth Diagnostics also invites ASTRO attendees to the Satellite Symposium, “Precision in PSMA: Why Agent Selection Matters More Than Ever,” on Sunday, September 27, from 12:00 to 1:00 p.m. ET, in Theater 2 on the ASTRO Exhibit Floor. This program will examine the evolving role of PSMA radiopharmaceutical imaging agents and their potential impact on patient care. Experts in nuclear medicine and urology, including Sean Collins, MD, PhD, Professor of Radiation Oncology at the University of South Florida, will review emerging clinical evidence, including recent head-to-head study data, and discuss implications for precision oncology. Attendees can also visit Blue Earth Diagnostics at Booth #2147.

For complete details on the sessions and a list of scientific presentations, please refer to the ASTRO 2026 Annual Meeting online program.

POSLUMA^® (flotufolastat F 18)
Date: Tuesday, September 29, 2026
Title: Impact of Clinical Factors on ¹⁸F-Piflufolastat and ¹⁸F-Flotufolastat Detection Rates in Patients with Recurrent Prostate Cancer Post-prostatectomy: Results from an Intra-patient Head-to-head Study
Presenter: Alain Chaglassian, MD, MPH, Blue Earth Diagnostics Inc., Needham, MA, USA
Session Type: Poster presentation
Session Time: 2:15 – 3:30 PM ET
Abstract ID: 3320

Date: Wednesday, September 30, 2026
Title: A Prospective Single-Arm Study of POSLUMA PET in Very Low Prostate-Specific Antigen Recurrence Following Prostatectomy
Presenter: Jacob Hogan, MD, Harvard Radiation Oncology Program, Boston, MA, USA
Session Type: Poster presentation
Session Time: 8:30 – 8:35 AM ET 
Abstract ID: 1222

Axumin^® (fluciclovine F 18)
Date: Sunday, September 27, 2026
Title: ¹⁸F Fluciclovine PET in Postoperative Target Delineation and Recurrence Detection in Resected Brain Metastasis: Pre-Planned Analysis of a Prospective Trial
Presenter: Hanan N. Hassan, MD, Department of Radiation Oncology, Miami Cancer Institute, Baptist Health South Florida, Miami, FL, USA
Session Type: Poster presentation
Session Time: 3:00 – 4:00 PM ET
Abstract ID: 2085

About Bracco
Bracco Group, founded in 1927, is a global leader in diagnostic imaging, committed to advancing healthcare and improving people’s lives by shaping the future of prevention and precision medicine.

The company operates in the healthcare sector across more than 100 countries with a workforce of over 4,000 employees and consolidated annual revenues of approximately €2 billion, 88% generated by international markets.

With a strong commitment to innovation – investing around 9% of its reference turnover in Research & Development – Bracco develops and provides a broad portfolio of pharmaceutical products for diagnostic imaging, including contrast agents for X-ray, Computed Tomography (CT), and Magnetic Resonance Imaging (MRI), as well as microbubbles for Contrast Enhanced Ultrasound (CEUS), and Molecular Imaging through radioactive tracers and novel PET imaging agents, alongside AI-based solutions. It is also a global market leader in advanced contrast management technologies for cardiovascular angiography and radiology imaging.

Discover more at www.bracco.com.

About Blue Earth Diagnostics
Blue Earth Diagnostics, a part of the Bracco Group, is a global company advancing precision molecular imaging to support timely decisions and better patient outcomes. Founded in 2014, we work closely with clinicians and collaborators, bringing deep expertise to the development and delivery of positron emission tomography (PET) radiopharmaceuticals. Our growing portfolio helps uncover disease sooner and guide treatment choices across multiple disease states, including oncology and cardiology. Backed by a dedicated team, we deliver clear answers when decisions matter most.

For more information, please visit: www.blueearthdiagnostics.com.

POSLUMA^® and Axumin^® are registered trademarks of Blue Earth Diagnostics.

U.S. Indication and Important Safety Information About POSLUMA

INDICATION

POSLUMA^® (flotufolastat F 18) injection is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer.

• with suspected metastasis who are candidates for initial definitive therapy
• with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level

IMPORTANT SAFETY INFORMATION

• Image interpretation errors can occur with POSLUMA PET. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of POSLUMA for imaging metastatic pelvic lymph nodes in patients prior to initial definitive therapy seems to be affected by serum PSA levels and risk grouping. The performance of POSLUMA for imaging patients with biochemical evidence of recurrence of prostate cancer seems to be affected by serum PSA levels. Flotufolastat F 18 uptake is not specific for prostate cancer and may occur in other types of cancer, in non-malignant processes, and in normal tissues. Clinical correlation, which may include histopathological evaluation, is recommended.
• Risk of Image Misinterpretation in Patients with Suspected Prostate Cancer Recurrence: The interpretation of POSLUMA PET may differ depending on imaging readers, particularly in the prostate/prostate bed region. Because of the associated risk of false positive interpretation, consider multidisciplinary consultation and histopathological confirmation when clinical decision-making hinges on flotufolastat F 18 uptake only in the prostate/prostate bed region or only on uptake interpreted as borderline.
• POSLUMA use contributes to a patient’s overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Advise patients to hydrate before and after administration and to void frequently after administration. Ensure safe handling to minimize radiation exposure to the patient and health care providers.
• The adverse reactions reported in ≥0.4% of patients in clinical studies were diarrhea, blood pressure increase and injection site pain.
• Drug Interactions: androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, may result in changes in uptake of flotufolastat F 18 in prostate cancer. The effect of these therapies on performance of POSLUMA PET has not been established.

To report suspected adverse reactions to POSLUMA, call 1-844-POSLUMA (1-844-767-5862) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Full POSLUMA prescribing information is available at www.posluma.com/prescribing-information.pdf.

U.S. Indication and Important Safety Information About Axumin

INDICATION

Axumin^® (fluciclovine F 18) injection is indicated for positron emission tomography (PET) imaging in men with suspected prostate cancer recurrence based on elevated blood prostate-specific antigen (PSA) levels following prior treatment.

IMPORTANT SAFETY INFORMATION

• Image interpretation errors can occur with Axumin PET imaging. A negative image does not rule out recurrent prostate cancer and a positive image does not confirm its presence. The performance of Axumin seems to be affected by PSA levels. Axumin uptake may occur with other cancers and benign prostatic hypertrophy in primary prostate cancer. Clinical correlation, which may include histopathological evaluation, is recommended.
• Hypersensitivity reactions, including anaphylaxis, may occur in patients who receive Axumin. Emergency resuscitation equipment and personnel should be immediately available.
• Axumin use contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased risk of cancer. Safe handling practices should be used to minimize radiation exposure to the patient and health care providers.
• Adverse reactions were reported in ≤1% of subjects during clinical studies with Axumin. The most common adverse reactions were injection site pain, injection site erythema and dysgeusia.

To report suspected adverse reactions to Axumin, call 1-855-AXUMIN1 (1-855-298-6461) or contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please see Axumin full Prescribing Information.

Contacts: 
For Blue Earth Diagnostics
Monica Planinsek
Corporate Communications Manager
Monica.Planinsek@bracco.com
(M) (207) 838-3863

Media 
Shannon Moore
Shannon.Moore@edelman.com
(M) (714) 348-4838

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