Great update: 67Cu-SAR-bisPSMA gets fast tracked by FDA

[Maxone73]

And it looks like it is way more reliable than 177Lu...

The FDA has granted Fast Track Designation to 67Cu-SAR-bisPSMA, a novel radiopharmaceutical therapy for metastatic castration-resistant prostate cancer (mCRPC). Preliminary data from the SECuRE trial show promising results, with 73% of patients experiencing PSA reductions and 45% seeing drops greater than 50%. Notably, a patient who received two doses of 8 GBq 67Cu-SAR-bisPSMA achieved complete remission, with undetectable PSA levels for 13 months.

Final trial results are expected in September 2026, and continued remission in early responders could signal a breakthrough for advanced prostate cancer treatment.

prostatewarriors.com/2025/0...

[GardenReno]

sounds very promising

[DrawingSnowmen]

That's very exciting. If you were going to do a trial would you do Cu-67 or Ac-225?

[Maxone73 in reply to DrawingSnowmen]

I would try this first, then Ac because it seems to work well with micro mets 😀

[DrawingSnowmen in reply to Maxone73]

I don't think they'd let you do both currently. What they're reporting out so far seems similar in terms of percentages of any response and PSA50. Cu-67 seems like maybe fewer side effects?

[Graham49]

Thanks Maxone. I hope it is cheap enough for us to get it in the UK!

[Maxone73 in reply to Graham49]

Me too! I am worried about access now, I think we already have some great tools in the world.

[dhccpa]

PSA drops are always nice, but how about the Mets? Did they die or disappear?

[Maxone73 in reply to dhccpa]

Who knows? I know that today my psa went from 0.01 to 0.02 and I was almost freaking out!!! But then the nurse interviewed me and she said that not drinking anything for 10 hours before having my blood drawn is not a brilliant idea if i want reliable results! (I was in a hurry so like 5 minutes after waking up I was already in the car!)

[dhccpa in reply to Maxone73]

A waterless fast? Extreme discipline!

[Maxone73 in reply to dhccpa]

Nah, just a stupid thing to do, but between the cold weather and the early hour, I really didn't even think about drinking some water

[Maxone73 in reply to dhccpa]

Seriously, I will check, but when they talk about complete remission it usually means that it's not visible on the scans. If I remember correctly they have published also the guy's scan to show the response.

[dhccpa in reply to Maxone73]

Ok thanks!