Copper-64 SAR-bisPSMA
An experimental PET tracer for prostate cancer that binds the same target as approved PSMA scans (PSMA) but, because its radioactive tag lasts longer, can be re-imaged a day later to catch small deposits the first picture missed. It is not yet approved for sale.
Overview
64Cu-SAR-bisPSMA is Clarity Pharmaceuticals' diagnostic partner to its therapeutic 67Cu-SAR-bisPSMA, developed as a Targeted Copper Theranostic pair. In the phase 1 PROPELLER trial (NCT04839367, 30 men with intermediate-to-high-risk untreated prostate cancer), the optimal 200 MBq dose detected primary prostate cancer in 100% and 85.7% of patients by two independent readers, versus 77.8% and 83.3% for same-patient 68Ga-PSMA-11, with significantly higher SUVmax and tumour-to-background ratio (p<0.001 for both readers). In the Co-PSMA trial (NCT06907641, 50 men with biochemical recurrence after prostatectomy), 24-hour 64Cu-SAR-bisPSMA imaging found more than double the per-patient lesion count of same-day 68Ga-PSMA-11 (mean 1.26 vs 0.48 lesions, p<0.0001) and changed management in 44% of patients, published in European Urology in 2026.
The US FDA granted 64Cu-SAR-bisPSMA fast-track designation in August 2024 for PET imaging of PSMA-positive prostate cancer with suspected metastasis in patients eligible for initial definitive therapy. A registrational phase 3 trial, CLARIFY (NCT06056830), is evaluating same-day and next-day imaging ahead of radical prostatectomy. The therapeutic isotope pairing, 67Cu-SAR-bisPSMA, is being tested in the SECuRE trial (NCT04868604) for PSMA-expressing metastatic castration-resistant prostate cancer; both 64Cu- and 67Cu-SAR-bisPSMA remain unregistered products not yet assessed for approval by FDA or Australia's TGA, per the company's own disclosures.
- Detector ring
- PSMA ligand
- 511 keV photon pair
1.Copper-64 SAR-bisPSMA slips into a pocket on PSMA.
Trials
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Landmark trials
Latest papers
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Similar pages
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