1. That's not really a counter-argument, is it? If they have PSMA-positive pelvic lymph nodes, they were excluded. This is the exact patient population that, without PSMA-PET, would have been included on this trial.... and the exact patient population that would have shown zero benefit to addition of ENI (precisely for the reasons you mention). I guess I'm failing to see how this countermands my "PSMA-PET is the reason the bPFS is 90%"
2. Sure, identifying cN1 vs cM1 disease doesn't make any difference to my argument.
Both counter-arguments are groups of patients, that, historically, would have been included in these high-risk trials (given issues with bone scan/CT scan for staging). By removing these groups of patients (that most would agree, ENI would have zero benefit), they have found an enriched population that does benefit from ENI.
Not all of these patients have microscopic nodal disease.... but the answer may be somewhere around the range of 95 - 81 at 8-year bPFS, or about 14%. They enrolled people with a >20% risk of LN involvement by Roach Formula (which we all know overestimates LN risk). Is the risk ~14%? Maybe.
Did this entire cohort do better than expected? Yes - even 81% bPFS for high-risk is pretty good. Was that because some proportion of patients were spared local therapy when they had small volume cM1 disease (caught on PSMA-PET that would not have been caught on bone scan/CT C/A/P?).
What would be interesting is, of all the patients they screened, how many had a PSMA-PET that made them ineligible to treatment?
View attachment 324141
Above are the curves from 9413, with a 8-year bPFS of ~30-40%. Even PORT alone looks twice(!) as good as the 'winner' in this trial. Maybe it's the RT dose difference (70.2 conventional vs 68 in hypofx). Maybe it's the PSMA-PET. Maybe it's Maybelline.