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FDA Grants Fast Track Designation to 64Cu-SAR-bisPSMA PET Agent for Prostate Cancer
Currently in phase III trials, the 64Cu-SAR-bisPSMA PET agent reportedly offers a longer half-life and higher tumor uptake than other radiopharmaceuticals for prostate cancer imaging.
The emerging positron emission tomography (PET) agent 64Cu-SAR-bisPSMA has garnered a fast track designation status from the Food and Drug Administration (FDA).
Separate phase I trials have demonstrated the safety and efficacy of 64Cu-SAR-bisPSMA for the imaging of prostate cancer (PCa) prior to radical prostatectomy and in patients with biochemical recurrence of PCa, according to Clarity Pharmaceuticals, the developer of the PET agent.
Recent research suggested that 64Cu-SAR-bisPSMA has a higher detection rate than 68Ga PSMA-11 PET/CT for prostate cancer. Currently in phase III trials, the 64Cu-SAR-bisPSMA PET agent recently garnered fast track designation status from the Food and Drug Administration (FDA). (Images courtesy of the Society of Nuclear Medicine and Molecular Imaging (SNMMI)).
In comparative research presented at the 2023 Society of Nuclear Medicine and Molecular Imaging (SNMMI) conference, researchers found that 64Cu-SAR-bisPSMA had a higher detection rate for PCa and a higher median tumor-to-background ratio (TBR) in comparison to 68Ga PSMA-11 PET/CT. Clarity Pharmaceuticals noted that current phase III trials are ongoing for 64Cu-SAR-bisPSMA.
"We believe that 64Cu-SAR-bisPSMA could be a game changer in prostate cancer diagnosis. Due to its dual targeting structure, bisPSMA, and the longer half-life of copper-64, enabling next-day imaging, this unique product has shown higher tumor uptake and retention and exhibited a capability of detecting much smaller lesions,” noted Alan Taylor, the executive chairperson for Clarity Pharmaceuticals.
Prostate MRI Study Examines Key Predictors of False-Negative and False-Positive Results
February 17th 2025Researchers found that patients with high PSA density have more than double the risk of false-negative findings on prostate MRI and those with low PSA density are significantly less likely to have false-positive results.
Emerging PET/CT Agent Shows Promise in Detecting PCa Recurrence in Patients with Low PSA Levels
February 13th 202518F-DCFPyL facilitated detection of recurrent prostate cancer in 51 percent of patients with PSA levels ranging between 0.2 to 0.5 ng/ml, according to new research presented at the American Society of Clinical Oncology Genitourinary Cancers (ASCO-GU) Symposium.
What a New Meta-Analysis Reveals About PET/CT Radiotracers for csPCa
February 6th 2025The PET/CT agent 18F-PSMA-1007 offered the highest surface under the cumulative ranking curve (SUCRA) out of nine radiotracers at the patient and lesion level for detecting clinically significant prostate cancer (csPCa), according to a meta-analysis.
Can MRI-Based Deep Learning Improve Risk Stratification in PI-RADS 3 Cases?
January 30th 2025In external validation testing, a deep learning model demonstrated an average AUC of 87.6 percent for detecting clinically significant prostate cancer (csPCA) on prostate MRI for patients with PI-RADS 3 assessments.
Emerging PET Agent Garners Second FDA Fast Track Designation for Prostate Cancer Imaging
January 24th 2025In addition to an August FDA fast track designation for PSMA PET imaging in patients with suspected metastasis, the radiopharmaceutical 64Cu-SAR-bisPSMA has earned another fast track designation for imaging of biochemical recurrence.
