Blue Earth Diagnostics, a leading provider of PET radiopharmaceuticals, is set to present findings on POSLUMA (flotufolastat F 18) injection at the ASTRO 2023 Annual Meeting. POSLUMA aids in PET scans to detect prostate-specific membrane antigen (PSMA) positive lesions in prostate cancer patients. Key presentations include Phase 3 results demonstrating its effectiveness in detecting disease at low PSA levels. Blue Earth Diagnostics will also host an Industry-Expert Theater event. Safety information regarding POSLUMA emphasizes potential image interpretation errors and cumulative radiation exposure. The presentations aim to provide valuable insights into prostate cancer diagnosis and management.
Blue Earth Diagnostics, a subsidiary of Bracco and a renowned leader in the field of PET radiopharmaceuticals has unveiled its plans for presentations at the forthcoming American Society for Therapeutic Radiology and Oncology (ASTRO) 2023 Annual Meeting in San Diego, California, scheduled from October 1 to 4, 2023. The company intends to shed light on POSLUMA (flotufolastat F 18) injection, formerly known as 18F-rhPSMA-7.3, which plays a pivotal role in positron emission tomography (PET) scans for identifying prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer. This applies to individuals undergoing initial definitive therapy or facing suspected metastasis, as well as those with suspected recurrence based on elevated serum prostate-specific antigen (PSA) levels.
David E. Gauden, D.Phil., the Chief Executive Officer of Blue Earth Diagnostics, expressed enthusiasm about sharing vital clinical insights regarding POSLUMA with the radiation oncology community at ASTRO 2023. He highlighted the Phase 3 findings from the SPOTLIGHT trial, showcasing POSLUMA’s exceptional ability to detect recurrent disease even at low PSA levels. Dr. Ashesh Jani will present detailed information on its diagnostic performance at PSA levels below 1 ng/mL during an oral presentation. Additionally, Dr. Phillip Kuo will reveal further results from the Phase 3 LIGHTHOUSE trial, focusing on POSLUMA’s performance in newly diagnosed patients with high/very high-risk prostate cancer who obtained negative results from conventional imaging. Blue Earth Diagnostics will also host an Industry-Expert Theater event titled ‘POSLUMA: Precision PET Imaging that is Truly Revealing.’
Here are the highlights of the scientific presentations by Blue Earth Diagnostics and its collaborators:
Monday, October 2, 2023
– Oral Presentation
– Title: Detection Rate of 18F-rhPSMA-7.3 PET in Patients with Suspected Prostate Cancer Recurrence at PSA Levels <1 ng/mL: Data from the Phase 3 SPOTLIGHT Study
– Presenter: Ashesh B. Jani, MD, FASTRO, Department of Radiation Oncology, Winship Cancer Institute of Emory University, Atlanta, GA, for the SPOTLIGHT Study Group
– Session Type: Oral
– Session Title: SS11 – GU 3 Novel Prognostication Techniques for Prostate Cancer
– Presentation Time: 3:30 – 3:37 PM PT
– Location: Room 6 D/E
– Presentation No.: 160
Tuesday, October 3, 2023
– Poster Presentation
– Title: Diagnostic Performance of 18F-rhPSMA-7.3 PET in Men with Newly Diagnosed High-risk Prostate Cancer and Negative Conventional Imaging
– Presenter: Phillip H. Kuo, MD, Ph.D., Departments of Medical Imaging, Medicine, and Biomedical Engineering, University of Arizona, Tucson, AZ, on behalf of Gary A. Ulaner, MD, Ph.D., Hoag Family Cancer Institute, Irvine, CA, and the University of Southern California, Los Angeles, CA, for the LIGHTHOUSE Study Group
– Session Title: PQ 06 – Poster Q&A 06 – Session 06 – Genitourinary Cancer, Patient Safety, and Nursing
– Presentation Time: 2:30 – 3:45 PM PT
– Location: Hall B1
– Presentation No.: 2972
Blue Earth Diagnostics cordially invites all participants of the 2023 ASTRO Annual Meeting to attend these presentations and visit their exhibit at Booth 2223. Moreover, they will be hosting an Industry-Expert Theater event titled “POSLUMA: Precision PET Imaging that is Truly Revealing,” featuring Dr. Nicholas Zouain, Radiation Oncologist, Medical Director of West Florida Radiation Therapy, US Oncology Network, Clearwater, FL. This event is scheduled for Sunday, October 1, 2023, from 12:00 PM to 1:00 PM PT, taking place in Theater 1 at the San Diego Convention Center. For comprehensive session details and a list of scientific presentations, please refer to the ASTRO online program.
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, either candidate for initial definitive therapy or with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.
IMPORTANT SAFETY INFORMATION
– Image interpretation errors may occur with POSLUMA PET. A negative image does not exclude the presence of prostate cancer, and a positive image does not confirm its presence. POSLUMA’s performance for imaging metastatic pelvic lymph nodes in patients before initial definitive therapy appears influenced by serum PSA levels and risk grouping. Its performance in imaging patients with biochemical evidence of prostate cancer recurrence also appears linked to PSA levels. Flotufolastat F 18 uptake is not exclusive to prostate cancer and may occur in other cancer types, non-malignant conditions, and normal tissues. Therefore, clinical correlation, possibly involving histopathological evaluation, is recommended.
– Regarding patients with suspected prostate cancer recurrence, the interpretation of POSLUMA PET results can vary among different readers, particularly in the prostate/prostate bed region. Due to the potential risk of false positive interpretations, it is advisable to consider multidisciplinary consultation and histopathological confirmation when clinical decision-making hinges solely on flotufolastat F 18 uptake in the prostate/prostate bed region or uptake that is interpreted as borderline.
– The use of POSLUMA contributes to a patient’s overall long-term cumulative radiation exposure, which is associated with an increased cancer risk. Patients should be advised to hydrate before and after administration and to void frequently afterward. Ensuring safe handling is essential to minimize radiation exposure for both patients and healthcare providers.
– Adverse reactions reported in clinical studies in ≥0.4% of patients included diarrhea, blood pressure increase, and injection site pain.
– Drug interactions: The impact of androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, on the uptake of flotufolastat F 18 in prostate cancer has not been established.
To report suspected adverse reactions to POSLUMA, please call 1-844-POSLUMA (1-844-767-5862) or contact the FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.
