This is a randomized, open-label, pilot study assessing the impact of a short course of bicalutamide on PSMA expression in patients with prostate cancer belonging to the intermediate unfavorable or high risk group, who have low levels of PSA. Adult patients with biochemically recurrent prostate cancer (BCR PCa) who have a PSA of less than 1.0 ng/mL and who have undergone complete prostatectomy and/or will be undergoing radiotherapy, in combination with standard of care bicalutamide, will be recruited to this study. Patients will be randomized in a 1:1 ratio into Group A (baseline PSMA PET/CT only with bicalutamide standard of care) or Group B (baseline PSMA PET/CT and an additional PSMA PET/CT after 2 weeks of bicalutamide).

Start Date31 Oct 2026

Sponsor / Collaborator

Washington University School of Medicine

[+1]

NCT06881823

/ WithdrawnPhase 1/2

NeoPSMA: A Phase I/II, Open-label, Multi-center Study of Neoadjuvant Treatment With [177Lu]Lu-PSMA-R2 (AAA602) and [225Ac]Ac-PSMA-R2 (AAA802) in Adults With Prostate-specific Membrane Antigen (PSMA) Positive High-risk Localized Prostate Cancer (HRLPC) Prior to Radical Prostatectomy and Pelvic Lymph Node Dissection

The purpose of this trial is to learn more about the effects of AAA602 and AAA802 in men with prostate-specific membrane antigen (PSMA) positive high-risk localized prostate cancer (HRLPC) before surgery to remove the prostate and lymph nodes present in the pelvis area. Lymph nodes are small structures near the prostate that help fight infections. These lymph nodes are removed during surgery because they are a site the disease can spread to.

Start Date29 Jun 2026

Sponsor / Collaborator

Novartis Pharmaceuticals Canada, Inc.

NCT07285057

/ RecruitingPhase 2IIT

Diagnostic Utility of rhPSMA-7.3 (18F) PET /CT Imaging in Patients With Prostate Cancer on Active Surveillance

This investigator-initiated, prospective study evaluates the diagnostic utility of rhPSMA-7.3 (¹⁸F) PET/CT (flotufolastat F18, marketed as POSLUMA®) in men with biopsy-proven, low-risk or favorable intermediate-risk prostate cancer managed with active surveillance. The study aims to determine whether the addition of PSMA-based PET/CT to standard multiparametric MRI (mpMRI) improves detection of clinically significant prostate cancer compared to MRI alone. Eligible participants will undergo rhPSMA-7.3 (¹⁸F) PET/CT and mpMRI prior to confirmatory prostate biopsy. Biopsies will target areas identified on MRI, PET/CT, or both, and histopathologic outcomes will serve as the reference standard. The study will assess lesion-level concordance between PET/CT, MRI, and pathology, and evaluate the predictive value of PET/CT for disease upgrading. Approximately 120 participants will be enrolled at Mount Sinai Hospital over 12 months. Study participation will involve one imaging visit, one confirmatory biopsy, and follow-up through review of clinical results. There is minimal risk to participants beyond standard diagnostic procedures. The study is funded jointly by the Icahn School of Medicine at Mount Sinai and Blue Earth Diagnostics, which provides the imaging agent flotufolastat F18 and technical support.

Start Date10 Feb 2026

Sponsor / Collaborator

Icahn School of Medicine at Mount Sinai

[+1]

100 Clinical Results associated with Flotufolastat F-18

100 Translational Medicine associated with Flotufolastat F-18

100 Patents (Medical) associated with Flotufolastat F-18

Literatures (Medical) associated with Flotufolastat F-18

01 May 2026·European Journal of Nuclear Medicine and Molecular Imaging

An intra-patient contemporaneous comparison of 18F-piflufolastat and 18F-flotufolastat urinary radioactivity and pelvic region detection rates in men with low PSA biochemical recurrence of prostate cancer after radical prostatectomy

Article

Author: Purysko, Andrei S ; Sykes, James ; Pathak, Ram A ; Shore, Neal ; Andrews, Jack R ; Josephson, David ; Gartrell, Benjamin A ; Penny, Ross ; Saltzstein, Daniel R ; Kuo, Phillip H ; Nordquist, Luke T ; Davis, Phillip ; Helfand, Brian T

Abstract:

Purpose:

This prospective, multicentre, intra-patient comparator study assessed urinary radioactivity, and patient-level and region-level detection rates (DR) with PSMA-PET radiopharmaceuticals, 18 F-piflufolastat ( 18 F-DCFPyL) and 18 F-flotufolastat ( 18 F-rhPSMA-7.3) in patients with biochemical recurrence (BCR) of prostate cancer to evaluate the hypothesis that lower urinary radioactivity is observed with 18 F-flotufolastat.

Methods:

Patients with low PSA (≤0.5 ng/mL) BCR ≥6 months post-prostatectomy with undetectable PSA post-surgery, scheduled for standard-of-care 18 F-piflufolastat PSMA-PET were enrolled. Patients underwent PET/CT 60 minutes post- 18 F-piflufolastat (9 mCi) administration, and a second PET/CT on the same scanner 1–10 days later, 60 minutes post- 18 F-flotufolastat (8 mCi) administration. The primary endpoint was the difference in urinary radioactivity (SUV mean ) between the radiopharmaceuticals. Secondary endpoints included patient-level and region-level DR for each radiopharmaceutical, assessed by two blinded readers (a third resolved disagreements, allowing majority reads).

Results:

Fifty-five evaluable patients (mean PSA, 0.28 ng/mL) were enrolled. Median bladder SUV mean was significantly higher with 18 F-piflufolastat (29.0; interquartile range, 18.9–40.8) than 18 F-flotufolastat (10.9; interquartile range, 6.0–18.5; p < 0.001 [Wilcoxon signed-rank test]). Majority read patient-level DR were 27.3% (15/55) for 18 F-piflufolastat and 45.5% (25/55) for 18 F-flotufolastat. Region-level DR for 18 F-piflufolastat and 18 F-flotufolastat, were 10.9% (6/55) and 18.2% (10/55) in the prostate bed, 14.5% (8/55) and 16.4% (9/55) in pelvic lymph nodes, and 7.3% (4/55) and 21.8% (12/55) in extra-pelvic sites. Among patients with PSA ≤0.2 ng/mL, 38.1% (8/21) and 52.4% (11/21) had positive 18 F-piflufolastat and 18 F-flotufolastat scans, respectively.

Conclusions:

This intra-patient comparator shows 18 F-flotufolastat has significantly lower urinary radioactivity than 18 F-piflufolastat, which may help to optimise image assessment in regions close to the urinary tract.

Clinical trial registration:

Trial registration, clinicaltrials.gov: NCT06604442. Registered September 2024.

01 May 2026·Urology Practice

Utility of ¹⁸ F-Flotufolastat Positron Emission Tomography/Computed Tomography Imaging in High-Risk Prostate Cancer in a Real-World Setting

Article

Author: Zinar, Cheryl ; Stollman, Nachum ; Meyer, Kayla ; Belkoff, Laurence ; Zeltser, Ilia ; Taylor, Zachariah

INTRODUCTION:

This investigator-initiated, prospective, low-intervention, phase 3 study evaluated the clinical utility of prostate-specific membrane antigen (PSMA) positron emission tomography (PET)/CT imaging with ¹⁸F-flotufolastat (formerly ¹⁸F-rhPSMA-7.3) in men with newly diagnosed high-risk prostate cancer (PCa) and negative conventional imaging. The primary end point was the rate of clinical upstaging and its effect on subsequent management.

METHODS:

A total of 113 treatment-naïve men meeting National Comprehensive Cancer Network high-risk criteria were enrolled; 110 underwent PSMA PET/CT with ¹⁸F-flotufolastat. Before imaging, all patients had negative conventional staging, as determined by bone scan and CT or MRI. Imaging was performed 50 to 70 minutes post injection of 8 mCi ± 20% ¹⁸F-flotufolastat. The results were interpreted by board-certified nuclear medicine physicians trained in PSMA imaging.

RESULTS:

¹⁸F-flotufolastat identified extraprostatic disease in 36 of 110 patients (32.7%). Among them, 15 of 36 (41.7%) had isolated regional lymph node (N1) involvement, while 21 of 36 (58.3%) demonstrated distant metastatic (M1) disease. Of the patients who were upstaged, 34 of 36 patients (94.4%) had a change in their treatment plan. The most common treatment intensification included the addition of an androgen receptor inhibitor and expanded radiotherapy fields (50.0%). Furthermore, 34.3% received up-front chemotherapy alongside an androgen receptor inhibitor and radiation. A minority (8.6%) proceeded with radical prostatectomy as a first step of a multimodality approach.

CONCLUSIONS:

PSMA PET/CT with ¹⁸F-flotufolastat led to clinical upstaging in nearly one-third of men with high-risk PCa and negative conventional imaging, resulting in significant treatment change in most patients. These findings support the integration of PSMA-targeted imaging into initial staging pathways for men with high-risk PCa.

01 Dec 2025·Journal of Nuclear Medicine Technology

Prostate Cancer Imaging with ¹⁸ F-Flotufolastat

Review

Author: Tempesta, Daniel ; Gilmore, David

Medical imaging is often used to determine the staging of the cancer and if it is localized or if it has spread. Metastatic prostate cancer is the concern and the lower survival rate, if not detected. Nuclear medicine has played a pivotal role in prostate metastasis detection and treatment for many decades. The emergence of prostate-specific membrane antigen (PSMA)-targeted PET radiopharmaceuticals has significantly advanced the imaging of prostate cancer. Among these, ¹⁸F-flotufolastat, commercially known as Posluma, represents a pivotal development in the detection and management of PSMA-positive lesions. Its favorable pharmacokinetics-including low urinary excretion and minimal bladder activity-enhance lesion detectability in the pelvic region, a common challenge in prostate imaging. Clinical trials such as LIGHTHOUSE and SPOTLIGHT demonstrated ¹⁸F-flotufolastat's high specificity, diagnostic accuracy, and safety profile across diverse patient populations. With a cyclotron-produced ¹⁸F isotope and a 110-min half-life, ¹⁸F-flotufolastat offers logistical advantages for imaging centers and flexibility in scan timing. As a PSMA-based agent, ¹⁸F-flotufolastat enables precise visualization of prostate cancer cells and metastatic sites, positioning it as a valuable tool in the evolving landscape of nuclear medicine and prostate cancer care.

News (Medical) associated with Flotufolastat F-18

22 Sep 2026

·www.prnewswire.com

Blue Earth Diagnostics to Present New Research Advancing Precision Molecular Imaging at ASTRO 2026

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 Eve r," 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 18 F-Piflufolastat and 18 F-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 . 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: . 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 . Full POSLUMA prescribing information is available at . 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 . Please see Axumin full Prescribing Information . Contacts: For Blue Earth Diagnostics Monica Planinsek Corporate Communications Manager [email protected] (M) (207) 838-3863 Media Shannon Moore [email protected] (M) (714) 348-4838 SOURCE Blue Earth Diagnostics 21% more press release views with Request a Demo

Radiation TherapyClinical Study

13 Jul 2026

·www.prnewswire.com

Blue Earth Therapeutics announces first participant dosed in Phase 1 clinical trial investigating Actinium (²²⁵Ac) rhPSMA-10.1 Injection in metastatic castration-resistant prostate cancer

The University College London (UCL) sponsored study evaluates safety, tolerability and radiation dosimetry of an investigational alpha‑emitting PSMA‑targeted radiopharmaceutical therapy, building on Blue Earth Therapeutics' radiohybrid platform. For Media and Investors only OXFORD, England, July 9, 2026 /PRNewswire/ -- Blue Earth Therapeutics, a clinical-stage radiopharmaceutical company and University College London (UCL) today announced initiation of a Phase 1 clinical trial (NCT07414940) evaluating Actinium (225Ac) rhPSMA-10.1 Injection, an investigational alpha‑emitting PSMA‑targeted radiopharmaceutical for the treatment of patients within clinical trials in metastatic castrate‑resistant prostate cancer (mCRPC). The study is sponsored by UCL and is being conducted at UCL Hospital, London. Blue Earth Therapeutics is providing funding and supply of investigational drug product. This Phase 1 study is designed to evaluate the safety and anti-tumour activity of Actinium (225Ac) rhPSMA-10.1 Injection in participants with PSMA‑positive mCRPC whose disease has progressed following prior therapy. Results from the study are expected to characterise the side effects of Actinium (225Ac) rhPSMA-10.1 Injection and to inform dose selection for subsequent research. Alpha-emitting radionuclides such as actinium-225 (225Ac) deliver a high amount of energy over a short distance in tissue, causing irreparable DNA damage to targeted cancer cells whilst aiming to limit exposure to surrounding healthy tissue. When incorporated into a PSMA-targeting molecule such as rhPSMA-10.1, this approach is designed to deliver localised radiation directly to prostate cancer lesions, potentially offering a targeted treatment strategy for patients with advanced cancer. Actinium (225Ac) rhPSMA-10.1 Injection is the second clinical candidate in Blue Earth Therapeutics' oncology pipeline, building on the company's ongoing Lutetium (¹⁷⁷Lu) rhPSMA‑10.1 Injection clinical programme, which is currently in a Phase 2 clinical trial. Together, these programmes reflect the company's work across both alpha‑ and beta‑emitting radiopharmaceutical therapies using its radiohybrid PSMA platform. UCL Cancer Institute director Professor Gert Attard said: "This study is an important step in advancing more precise treatment options for men with metastatic castrate-resistant prostate cancer. The combination of a highly targeted PSMA approach with the potent, short-range effects of an alpha-emitting radionuclide offers a promising strategy to deliver meaningful anti-tumour activity while limiting toxicity. Early-phase trials such as this are essential for determining safety, refining dose and guiding how these therapies can be integrated into personalised treatment pathways to improve outcomes for patients." "Initiation of this collaborative Phase 1 study represents an important milestone for Blue Earth Therapeutics and our investigational radiopharmaceutical therapy pipeline," said Dr David Gauden, Chief Executive Officer of Blue Earth Therapeutics. "Building on our clinical experience in both alpha‑ and beta‑emitting radiopharmaceutical therapies, we are combining the targeting precision of rhPSMA with the alpha‑emitting properties of actinium‑225 to explore a potential treatment approach for patients with advanced prostate cancer. We are very grateful to the team at UCL and to their patients for undertaking this study." About metastatic prostate cancer It has been forecast that in 2025 there would be 50,055 new cases of metastatic prostate cancer in the United States (de novo diagnoses plus recurrence from earlier stage diagnoses).1 Five-year survival for newly diagnosed metastatic prostate cancer is low, 40.1%.2 While death rates from prostate cancer have declined over the past three decades2, there is still considerable room to improve patient outcomes. About Radiohybrid Prostate‐Specific Membrane Antigen (rhPSMA) rhPSMA compounds are referred to as radiohybrid ("rh"), as each molecule possesses four distinct domains. The first consists of a Prostate‐Specific Membrane Antigen‐targeted receptor ligand. It is attached to two labelling moieties which may be radiolabelled with diagnostic isotopes such as 18F or 68Ga for PET imaging, or with therapeutic isotopes such as 177Lu or 225Ac for radioligand therapy, all of which are joined together by a modifiable linker which can be used to modulate important pharmacokinetic characteristics. Radiohybrid PSMA offers the potential for targeted treatment for men with prostate cancer and originated at the Technical University of Munich, Germany. Blue Earth Diagnostics acquired exclusive worldwide rights to rhPSMA diagnostic imaging technology from Scintomics GmbH in 2018, and therapeutic rights in 2020, and has sublicensed the therapeutic application to its sister company Blue Earth Therapeutics. About Blue Earth Therapeutics Blue Earth Therapeutics is a clinical stage company dedicated to advancing next-generation targeted radiotherapeutics to treat patients who have cancer and has been incubated within the Bracco family of companies. Other investors joined with Bracco in a Series A financing round in 2024. With proven management expertise across the spectrum of radiopharmaceutical and oncology drug development, as well as biotechnology start‐up experience, the Company aims to innovate and improve upon current technologies and rapidly advance new targeted therapies for serious diseases. Blue Earth Therapeutics has an emerging pipeline initially focused on prostate cancer. For more information, please visit: . 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 Actinium (225Ac) rhPSMA-10.1 Injection has not received a marketing authorisation in any country or region. Lutetium (177Lu) rhPSMA-10.1 Injection has not received a marketing authorisation in any country or region. References: Gallichio L et al, JNCI J Natl Cancer Inst (2022) 114(11): djac158 SEER 22 database, , last accessed July 2026 Contact: For Blue Earth Therapeutics Harriet Cheshire, Associate Director, Corporate Development and Communications [email protected] UKBET-rh-2600006 | July 2026 SOURCE Blue Earth Therapeutics 21% more press release views with Request a Demo

Phase 1Phase 2Radiation Therapy

28 Feb 2026

·www.prnewswire.com

Blue Earth Diagnostics Announces Positive Results from Head-to-Head Comparator Study of POSLUMA® (Flotufolastat F 18) and Piflufolastat F 18 Urinary Bladder Radioactivity in Men with Biochemical Recurrence of Prostate Cancer

Feb. 27, 2026 -- Blue Earth Diagnostics, a Bracco company and recognized leader in the development and commercialization of innovative positron emission tomography (PET) radiopharmaceuticals, today announced results from the first head-to-head study comparing urinary bladder radioactivity between two prostate-specific membrane antigen (PSMA)-targeted PET radiopharmaceuticals. This prospective, multicenter, intra-patient comparison evaluated urinary radioactivity and lesion detection rates of POSLUMA® (flotufolastat F 18) and piflufolastat F 18 in men with low prostate-specific antigen (PSA) biochemical recurrence (BCR) of prostate cancer following radical prostatectomy. The study met its primary endpoint, demonstrating statistically significant lower urinary bladder radioactivity with POSLUMA compared with piflufolastat F 18, as measured by mean standardized uptake value (SUVmean). Across 55 evaluable patients, median bladder SUVmean was 10.9 for POSLUMA and 29.0 for piflufolastat F 18, with a median difference of 15.1 (interquartile range, 8.5–27.0; p1. "For men who have already undergone surgery for prostate cancer, a rising PSA can be deeply concerning, especially when conventional imaging cannot clearly show whether or where the disease has returned," said Dr. Eugene Teoh, Chief Medical Officer of Blue Earth Diagnostics. "This head-to-head study provides important clinical evidence from a rigorous intra-patient comparison, demonstrating that POSLUMA exhibits significantly lower urinary radioactivity while maintaining meaningful detection capability in men with early biochemical recurrence. Urinary activity can impact image interpretation, which is of particular consideration at very low PSA levels, where precise localization is critical. These results reinforce the role of POSLUMA as a PSMA-PET imaging agent intelligently designed to support confident image assessment in anatomically challenging regions and reflect our continued commitment to advancing molecular imaging through high-quality clinical evidence." "This rigorous head-to-head study provides high quality evidence that POSLUMA has significantly lower urinary bladder radioactivity compared to piflufolastat F 18, confirming prior studies," said Phillip Kuo, Kuo Radiology LLC. "POSLUMA also exhibited higher detection rates for recurrence compared to piflufolastat F 18, which highlights its potential to improve patient management." Results from Blue Earth Diagnostics' head-to-head study have been published in the European Journal of Nuclear Medicine and Molecular Imaging and were just presented at the 2026 ASCO Genitourinary Cancers Symposium (ASCO GU), on February 26, 2026, in San Francisco, California. A prospective, multicenter, intra-patient head-to-head comparator study evaluating the urinary bladder radioactivity and lesion detection rates of POSLUMA® (flotufolastat F 18) and piflufolastat F 18 in men with low prostate-specific antigen (PSA) biochemical recurrence (BCR) of prostate cancer following radical prostatectomy. A total of 55 patients were evaluated with BCR and PSA levels ≤0.5 ng/mL. The study's primary endpoint was a calculated difference in bladder SUVmean as determined by quantification software. Secondary endpoints were detection rate analyses including patient level and subgroups, PSA level, prostate bed and related subregions, and pelvic lymph nodes. Blue Earth Diagnostics, an indirect subsidiary of Bracco Imaging S.p.A., is a growing international molecular imaging company focused on delivering innovative, well-differentiated diagnostic solutions that inform patient care. Formed in 2014, the Company's success is driven by its management expertise and supported by a demonstrated track record of rapid development and commercialization of positron emission tomography (PET) radiopharmaceuticals. Blue Earth Diagnostics' expanding portfolio encompasses a variety of disease states, including oncology. Blue Earth Diagnostics is committed to the timely development and commercialization of precision radiopharmaceuticals for potential use in diagnostic imaging. For more information, please visit: www.blueearthdiagnostics.com. Bracco Group was founded in 1927, operates in the healthcare sector across more than 100 countries and is a recognized global leader in diagnostic imaging. With a workforce of over 3,800 employees and consolidated annual revenues of approximately €2 billion—88% generated from international markets—Bracco demonstrates a strong commitment to innovation by investing around 9% of its reference turnover in Research & Development. These investments are primarily focused on imaging diagnostics and medical devices. The Group holds more than 2,000 active patents worldwide. Reference 1 Nordquist, L.T., Andrews, J.R., Kuo, P.H. et al. An intra-patient contemporaneous comparison of 18F-piflufolastat and 18F-flotufolastat urinary radioactivity and pelvic region detection rates in men with low PSA biochemical recurrence of prostate cancer after radical prostatectomy. Eur J Nucl Med Mol Imaging (2026). Online ahead of print. DOI: 10.1007/s00259-025-07732-y The content above comes from the network. if any infringement, please contact us to modify.

Clinical ResultRadiation Therapy

100 Deals associated with Flotufolastat F-18

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Prostatic Cancer	United States	Blue Earth Diagnostics Ltd.	25 May 2023

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Adenocarcinoma of prostate	Phase 3	United States	Blue Earth Diagnostics Ltd.	02 Mar 2020
Adenocarcinoma of prostate	Phase 3	Finland	Blue Earth Diagnostics Ltd.	02 Mar 2020
Adenocarcinoma of prostate	Phase 3	Germany	Blue Earth Diagnostics Ltd.	02 Mar 2020
Adenocarcinoma of prostate	Phase 3	Netherlands	Blue Earth Diagnostics Ltd.	02 Mar 2020
Non-metastatic prostate cancer	Phase 2	United States	Blue Earth Diagnostics Ltd.	27 Apr 2023
Recurrent Prostate Carcinoma	Phase 2	United States	Blue Earth Diagnostics Ltd.	27 Apr 2023
Metastatic castration-resistant prostate cancer	Phase 2	United States	Blue Earth Therapeutics Ltd.	20 Jul 2022
Metastatic castration-resistant prostate cancer	Phase 2	Belgium	Blue Earth Therapeutics Ltd.	20 Jul 2022
Metastatic castration-resistant prostate cancer	Phase 2	Germany	Blue Earth Therapeutics Ltd.	20 Jul 2022
Metastatic castration-resistant prostate cancer	Phase 2	Netherlands	Blue Earth Therapeutics Ltd.	20 Jul 2022

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06604442 (CTgov)	Phase 4	Recurrent Prostate Carcinoma	62	Piflufolastat (18F) (Piflufolastat (18F) PET)	bzfofcdbgu(yeursiotne) = laoiddcdpb bepygitkyy (feomhajkev, keuokfbock - uxkwolpmkr) View more	-	12 May 2026
NCT06604442 (CTgov)	Phase 4	Recurrent Prostate Carcinoma	62	Flotufolastat (18F) (Flotufolastat (18F) PET)	bzfofcdbgu(yeursiotne) = jslljuzwrx bepygitkyy (feomhajkev, bscaxnjszu - pdqxmjhhqo) View more	-	12 May 2026
NCT04186845 (SPOTLIGHT, ASCO_GU2026)	Phase 3	Prostatic Cancer Prostate-specific antigen (PSA)	121	18 F-flotufolastat (PSA level <0.5 ng/mL + Prostate Cancer with Biochemical Recurrence)	thixkjqvlf(kbjmdlnztd) = osbzegurwm iswqkyqkza (zgclvxxnzv ) View more	Positive	26 Feb 2026
NCT03995888 (CTgov)	Phase 1	Prostatic Cancer \| Adenocarcinoma of prostate	24	rhPSMA-7.3 (18F) Injection	rxryujoeju = whkemzabwf jtnxldgzbl (hwzmdlpsdw, wwqgeiosox - vqyyqrukjq) View more	-	12 Feb 2026
NCT05779943 (CTgov)	Phase 2	Recurrent Prostate Carcinoma \| Non-metastatic prostate cancer \| Adenocarcinoma of prostate	20	Computed Tomography+F18-rhPSMA-7.3+furosemide	vsxztyatog(kwbbhkvznt) = xuakjqtpre aaofotfatu (navauqpxjb, 3.71) View more	-	27 Oct 2025
NCT05779943 (Pubmed \| J Nucl Med)	Phase 2	Prostatic Cancer	20	18F-flotufolastat (rhPSMA-7.3)furosemideat (rhPSMA-7.3) (With-furosemide PET/CT studies)	xpdqhjgazj(awftguebsy) = gxkvwieloq esefqoagkf (hugqoqyyfz, 1.70 - 19.80) View more	Positive	01 Feb 2025
NCT05779943 (Pubmed \| J Nucl Med)	Phase 2	Prostatic Cancer	20	18F-flotufolastat (rhPSMA-7.3)furosemide(rhPSMA-7.3) (Without-furosemide PET/CT studies)	xpdqhjgazj(awftguebsy) = ocrcymfkpw esefqoagkf (hugqoqyyfz, 3.90 - 165.4) View more	Positive	01 Feb 2025
NCT04186845 (SPOTLIGHT, Biospace) Manual	Phase 3	Recurrent Prostate Carcinoma Prostate specific antigen	119	POSLUMA (PSA < 1 ng/mL)	irkbaafgdd(kxeaoyaaxp) = iuimoxyzha fgmmobgoqc (lidiitiktu )	Positive	01 Oct 2024
NCT04186845 (SPOTLIGHT, Biospace) Manual	Phase 3	Recurrent Prostate Carcinoma Prostate specific antigen	119	POSLUMA (PSA< 0.5 ng/mL)	irkbaafgdd(kxeaoyaaxp) = eyuyyhxgrn fgmmobgoqc (lidiitiktu )	Positive	01 Oct 2024
ASTRO2024	Not Applicable	Prostatic Cancer	-	18F-flotufolastat	cignslrzlt(hywbfsfodu) = bdserbwrdo pjmebdzswm (vrdcrsvufc )	-	01 Oct 2024
ASTRO2024	Not Applicable	Prostatic Cancer	-	F-Flotufolastat (Radical Prostatectomy)	cignslrzlt(hywbfsfodu) = fyalfpnnqp pjmebdzswm (vrdcrsvufc )	-	01 Oct 2024
ASTRO2024	Not Applicable	Non-metastatic prostate cancer	-	F-18 rhPSMA 7.3 PET/MRI	jjpvvbmsms(iowvpesthn) = nojumegdgm khfaicmwmk (ioneghtfsv ) View more	-	01 Oct 2024
NCT04186819 \| NCT04186845 (SPOTLIGHT, Literature) Manual	Phase 3	Prostatic Cancer	712	POSLUMA	qupzvuvukw(icwjzxmcrc) = pifjmfpqmv vgtrdxgrln (zvzjdwvjbr ) View more	Positive	06 Nov 2023
NCT04186819 (LIGHTHOUSE, ASTRO2023)	Phase 3	Prostatic Cancer PSMA	197	18F-rhPSMA-7.3 PET	cvvmorbpph(ubwuopmznf) = ztkimgztsg hxkgusbvxk (axanlxlmnf ) View more	Positive	01 Oct 2023

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