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.
Multinational Study Reaffirms Value of Adjunctive AI for Prostate MRI
June 16th 2025The use of adjunctive AI in biparametric prostate MRI exams led to 3.3 percent and 3.4 percent increases in the AUC and specificity, respectively, for clinically significant prostate cancer (csPCa) in a 360-person cohort drawn from 53 facilities.
New PSMA PET Prep Product Now Available in the U.S.
June 11th 2025Offering an extended shelf life, the FDA-approved Gozellix, a preparation kit for gallium-68 (68Ga) gozetotide injection, is indicated for use in PSMA PET imaging of prostate cancer patients with suspected recurrence or metastasis.
Study: AI-Generated ADC Maps from MRI More Than Double Specificity in Prostate Cancer Detection
June 5th 2025Emerging research showed that AI-generated ADC mapping from MRI led to significant increases in accuracy, PPV and specificity in comparison to conventional ADC mapping while achieving a 93 percent sensitivity for PCa.
ASCO: Study Reveals Significant Racial/Ethnic Disparities with PSMA PET Use for Patients with mPCa
May 30th 2025Latinx patients with metastatic prostate cancer were 63 percent less likely than non-Hispanic White patients to have PSMA PET scans, according to a study of 550 patients presented at the American Society of Clinical Oncology (ASCO) conference.
What a New PSMA PET/CT Study Reveals About Local PCa Treatment and High-Risk Recurrence
May 16th 2025For patients at high-risk for biochemical recurrence of prostate cancer, PSMA PET/CT findings revealed that 77 percent had one or more prostate lesions after undergoing local radiation therapy or radical prostatectomy, according to a recent study.
