GU Cancers 2024 | Learnings from the SPOTLIGHT study of 18F-rhPSMA-7.3 in prostate cancer
Benjamin Lowentritt, MD, Chesapeake Urology Research Associates, Baltimore, MD, discusses learnings from the Phase III SPOTLIGHT study (NCT04186845) of the PET radiopharmaceutical 18F-flotufolastat (18F-rhPSMA-7.3) in patients with recurrent prostate cancer. Due to the absence of the gold standard histopathology for recurrent prostate cancer, conventional imaging commonly serves as the standard of truth (SoT), though potentially less sensitive than the investigational agent. Findings from the trial highlights how SoT methods significantly influence key endpoints. This interview took place at the ASCO GU Cancers Symposium 2024 in San Francisco, CA.
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Transcript (edited for clarity)
So the SPOTLIGHT trial was the trial of the radio hybrid PSMA PET scan agent. That’s an F-18 agent that was looking specifically at the cohort of patients that have biochemical recurrence, so trying to find patients that are showing PSA increases after primary therapy with unknown site of ongoing disease. So what we’re presenting here at the at the meeting is about a couple of different things...
So the SPOTLIGHT trial was the trial of the radio hybrid PSMA PET scan agent. That’s an F-18 agent that was looking specifically at the cohort of patients that have biochemical recurrence, so trying to find patients that are showing PSA increases after primary therapy with unknown site of ongoing disease. So what we’re presenting here at the at the meeting is about a couple of different things. First is on the impact on patient decision making. So I think there was a big concern when you have these PET imaging is are we having an impact on what the patient and the physician are deciding to do after the fact? And what we would hope to see is what we saw, which is that in where we were able to track this, we saw that about 80 to 90% of patients had a change in overall planned strategy for what to do for that. And that included mostly probably 88% of those. So of those patients that changed, it was a change based on a positive scan. So changing either from a systemic therapy to a targeted therapy, or maybe from an observation to some sort of systemic and or targeted therapy. But there are also patients that had negative scans that then decided to go more for, um, either observation or potentially for salvage therapy to the prior prostatectomy site, for instance, but not necessarily undergo more widespread systemic or long term therapy with hormonal therapy. So we definitely saw things go both ways, and that’s really impactful and what you would want to see, because overall, 89% of patients did change their plan based on what the scan showed.
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