{"entity":{"id":"cu-64-sar-bispsma","kind":"drug","name":"Copper-64 SAR-bisPSMA","aka":["64Cu-SAR-bisPSMA","64Cu-bisPSMA"],"tldr":"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.","summary":"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.\n\nThe 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.","status":"phase-3","asOf":"2026-09-22","links":[{"label":"Lengyelova, Wong, Lenzo, Parker, Emmett; JCO 2023: 64Cu-SAR-bisPSMA (PROPELLER) PET imaging in confirmed prostate cancer","url":"https://ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.5039"},{"label":"Co-PSMA trial, European Urology 2026: prospective comparison of 64Cu-SAR-bisPSMA vs 68Ga-PSMA-11 for biochemical recurrence","url":"https://pubmed.ncbi.nlm.nih.gov/41904043/"},{"label":"ClinicalTrials.gov NCT04868604 (SECuRE)","url":"https://clinicaltrials.gov/study/NCT04868604"}],"tags":["PSMA","copper-64","theranostic pair","investigational"],"related":["tc-99m-psma-imaging","ga-68","cu-64","cu-67"],"indications":["prostate-high-risk","prostate-bcr","prostate-mcrpc"],"sections":[],"technologies":["psma-pet","pet-ct"],"targets":["psma"],"drugs":[],"companies":["clarity-pharmaceuticals"],"institutions":[],"pathways":[],"terms":[],"trials":["nct04868604"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"modality":"PET tracer","mechanism":"A bivalent small-molecule ligand carrying two PSMA-binding moieties on a single sarcophagine (SAR) chelator backbone, labelled with copper-64. The bivalent design and copper-64's 12.7-hour half-life allow same-day and next-day imaging from a single injection, and Clarity Pharmaceuticals reports two- to three-fold higher tumour uptake (SUVmax) than the standard-of-care 68Ga-PSMA-11 in head-to-head comparisons.","approvals":[],"mechanismSteps":[],"toxicity":[],"access":[],"regulatoryEvents":[]},"route":"/drugs/cu-64-sar-bispsma/","neighbours":{"drug":[{"id":"tc-99m-psma-imaging","kind":"drug","name":"Technetium Tc-99m PSMA agents (PSMA-I&S)","route":"/drugs/tc-99m-psma-imaging/"}],"isotope":[{"id":"cu-64","kind":"isotope","name":"Copper-64","route":"/isotopes/cu-64/"},{"id":"cu-67","kind":"isotope","name":"Copper-67","route":"/isotopes/cu-67/"},{"id":"ga-68","kind":"isotope","name":"Gallium-68","route":"/isotopes/ga-68/"}],"indication":[{"id":"prostate-bcr","kind":"indication","name":"Biochemical recurrence of prostate cancer","route":"/indications/prostate-bcr/"},{"id":"prostate-high-risk","kind":"indication","name":"Localised prostate cancer, high and very high risk","route":"/indications/prostate-high-risk/"},{"id":"prostate-mcrpc","kind":"indication","name":"Metastatic castration-resistant prostate cancer","route":"/indications/prostate-mcrpc/"}],"technology":[{"id":"pet-ct","kind":"technology","name":"PET/CT","route":"/technologies/pet-ct/"},{"id":"psma-pet","kind":"technology","name":"PSMA PET","route":"/technologies/psma-pet/"}],"target":[{"id":"psma","kind":"target","name":"PSMA","route":"/targets/psma/"}],"company":[{"id":"clarity-pharmaceuticals","kind":"company","name":"Clarity Pharmaceuticals","route":"/companies/clarity-pharmaceuticals/"}],"trial":[{"id":"nct04868604","kind":"trial","name":"64Cu-SAR-bisPSMA and 67Cu-SAR-bisPSMA for Identification and Treatment of PSMA-expressing Metastatic Castrate Resistant Prostate Cancer (SECuRE)","route":"/trials/nct04868604/"}]}}