7.5.2: A region that is 64Cu-SAR-bisPSMA PET-positive (i.e., includes at least one unequivocal PET-positive lesion) and is Reference Standard negative based on at least 1 evaluable timepoint, will be assigned as false positive (FP) for the region-level status.
If so - I think it should be read together with the earlier sections where the Reference Standard itself is constructed. It's hiearhachial, with Histopathology at level 1 (hence, the emphasis elsewhere about biopsies whenever possible).
In the COBRA data presented at ASCO GU 2025, they do present the results of 9 patients that had biopsies done. Perhaps this was the source of arguments with the FDA or whoever: they had proof that the test they were using as the benchmark is not accurate. Histopathology is!
---- Some relevant extracts form the COBRA protocol are given below.
While on this - I just want to point out a statement that sounds like a Clarity flex (Page 47):
A positive 64Cu-SAR-bisPSMA PET/CT within the target study population may indicate that this new imaging agent is more sensitive in detecting early recurrence than other available modalities. The 90- and 180-day follow-up timelines have been selected to allow for further development of the disease so the positive 64Cu-SAR-bisPSMA PET/CT findings can be validated using conventional, potentially less sensitive reference modalities. The selected follow-up timelines therefore enable evaluation of the diagnostic efficacy endpoints that relate to positive findings, but do not allow for a reliable assessment of false negative results.
They inserted a clause in the protocol, where they planned to wait for some time to give the cancer time to grow, so that the other imaging can finally see it!
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