How phase 3 trial data led to FDA approval of flotufolastat F 18 (Posluma) in prostate cancer

In this video, Brian F. Chapin, MD, discusses the key phase 3 LIGHTHOUSE and SPOTLIGHT data leading to the FDA approval of flotufolastat F 18 (Posluma) in prostate cancer.Chapin is an associate professor of urology at the University of Texas MD Anderson Cancer Center in Houston.

Video Transcript:

Could you discuss some of the key findings of the phase 3 LIGHTHOUSE and SPOTLIGHT trials that helped lead to this approval?

The approval of rh PSMA [came about] as a result of the phase 3 LIGHTHOUSE study and also the phase 3 SPOTLIGHT study. Both are in currently in publication. Specific to LIGHTHOUSE, we saw that rh PSMA had a high specificity for lymph node disease, and that met the prespecified threshold that was intended by the study. Also in LIGHTHOUSE, we were able to show a verified detection rate of extrapelvic disease in the range of 10% to 14%. Those are important aspects of the trial in basically showing that we can identify patients who perhaps are not staged based on our conventional imaging as a localized prostate cancer, which basically outperforms the conventional imaging that is currently used, whether that be bone scan CT or MRI scan, which is largely what's used in the US. In addition to the findings in LIGHTHOUSE, we had the findings in SPOTLIGHT showing an 83% overall detection rate for those in the biochemically recurrent setting. And that did range based on the PSA at presentation, so as low as 30% for the lower PSA values and as high as 85% for the higher PSA values. Obviously, identifying disease can help us to more accurately stage patients. I think the importance of this is that these are more accurate than our current imaging studies in helping us to better counsel patients on the expected treatment options given their current situation.

This transcript was edited for clarity.