https://clinicaltrials.gov/study/NCT05249127?term=Cobra%20clarity&rank=1
This is the trial design. Primary end point is PPV, safety and tolerability. A phase 1/2 was determining efficacy ie specificity and ultimately safety. Determining how specific Cu64 was based off numerous conventional methodologies ie histo and conventional imaging and PSA reduction if treated.
it was noted that they couldn't ethically biopsy every lesion, and they didn't expect there would be such a variance from day 0 to day 1. This was their first trial with a day 1.
this was never a comparison trial, it was an efficacy trial, which confirmed their specificity was on par.
i suspect the coPSMA trial will be a formal trial, that was investigator initiated by the way, that will determine how much variance there is between the two, and whether the histo agrees with either Cu64 or Ga68.
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