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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.
Study Emphasizes PSMA PET Staging of High-Risk, Hormone Sensitive Prostate Cancer
January 4th 2025In patients with high-risk, hormone sensitive prostate cancer who had no evidence of metastasis on conventional imaging, PSMA PET revealed polymetastatic disease in 24 percent of patients and M1 disease staging in 46 percent of patients.
Can MRI and Micro-Ultrasound Guidance Bolster Focal Laser Ablation Outcomes for Prostate Cancer?
January 3rd 2025For patients with localized prostate cancer and PI-RADS 3 or higher lesions, MRI-guided micro-ultrasound multifiber focal laser ablation had an 18 percent recurrence rate at one year, according to newly published research.
Study Reaffirms Low Risk for csPCa with Biopsy Omission After Negative Prostate MRI
December 19th 2024In a new study involving nearly 600 biopsy-naïve men, researchers found that only 4 percent of those with negative prostate MRI had clinically significant prostate cancer after three years of active monitoring.
Can AI Enhance PET/MRI Assessment for Extraprostatic Tumor Extension in Patients with PCa?
December 17th 2024The use of an adjunctive machine learning model led to 17 and 21 percent improvements in the AUC and sensitivity rate, respectively, for PET/MRI in diagnosing extraprostatic tumor extension in patients with primary prostate cancer.
What SPECT/CT May Reveal About Early Treatment Response for Pluvicto in Patients with mCRPC
November 13th 2024Researchers found that new prostate lesion detection on SPECT/CT at the beginning of a second cycle of 177 Lu-PSMA-617 for mCRPC was associated with an over sevenfold higher mortality risk.
