Well it took a while...but it looks like the trial has now been posted to the clinical trials website: https://clinicaltrials.gov/study/NCT06907641
The data on the magnitude of clinical management change will be the most interesting...probably together with the PSA response following salvage radiotherapy....
Imagine this...you have a rising PSA and are negative on the current SoC...you have a 64Cu scan...lesions are identified...you undergo salvage radiotherapy...your PSA then drops...you have a further 64Cu scan which shows that the lesions are either gone or smaller...and all this occurs within the 6 month period where the current SoC still can't locate the lesions which require treatment...
Much has been made about clinicians' willingness to switch products etc. I see it slightly differently (based on my profession). It will be the easiest litigation I will ever be involved in if a clinician doesn't recommend a patient undergo a 64Cu scan in circumstances where they have a rising PSA following radical prostatectomy and it transpires that they had lesions which could have been detected and treated...but weren't because the Cu64 scan wasn't recommended...
I wouldn't want to be the professional indemnity insurer of the clinicans who don't recommend and/or offer a 64Cu scan.
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Ann: Head-to-head IIT with SAR-bisPSMA, page-164
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