FYI TULSA-PRO FDA Approvals - There have been several FDA approvals...including recent enhancements to the TULSA procedure. You may not have been referencing TULSA regarding your FDA mention. I have read very positive things about nano-knife and may have considered that if my disease had not been so widespread in my prostate. Prior to my treatment, my prostate was enlarged. It is now slightly smaller than a normal prostate. TULSA resolved the enlarged prostate problem/nighttime trips to the bathroom and appears to have taken care of my cancer too. Maybe NanoKnife might be a good option for the younger man who is exploring his options. His very low Decipher score is a real positive for him.

If the ongoing TULSA head to head trial has similar results to the very large 30 month HIFU trial (see link to the study below) released in 2024 or better results as it should due to the active MRI thermal imaging. It might be a game changer as to how localized prostate cancer is treated. Perhaps, they will look at today's methods as being barbaric. The 30 month results indicated that HIFU was not inferior to prostate surgery. In some ways it was superior to surgery...this was for localized cancer and Gleason 7's. This study looked at the rate of cancer returning after either surgery or HIFU...and it compared side effects. This study had over 3,000 patients.

I am a living example of a person who had low grade, intermediate grade and high grade prostate cancer who had TULSA PRO. At this point, my results are perfect. The statistics with Gleason 8 indicate that even with surgery my odds of having the cancer return were high. They may come back with TULSA too....time will tell. But, at least my quality of life has not changed. If needed, I can be treated again with that method or others. If I had surgery, I still would have had undergone PSA tests every 3 months or so and I am guessing that I would have been scanned from time to time. They may have suggested hormone treatment too due to the two Gleason 8's.

A urologist at a famous teaching hospital has a video on youtube discussing his experience using TULSA on 11 patients. He mentioned that "politics" that may come into play as these new approaches might impact treatment methods. Impacting one's revenue source might cause some to push against newer and less invasive methods. With the advantage of PSMA PET scans that are much more accurate than previous scans, it is now possible to determine who has "spreading" disease and who does not. This doctor mentioned that TULSA is capable of killing high grade cancer and Dr. Scholls stated the same thing at the Prostate Cancer Research Institute.

I would encourage you to watch those videos such as this one where Dr. Scholls discusses TULSA. If you have not viewed this video, I hope you find it helpful and informative.

By the way, Dr. Scholls provides an independent opinion. He is a medical oncologist without skin in the game for the procedure.

This is the study comparing HIFU to surgery -
https://www.urologytimes.com/view/study-shows-hifu-noninferior-to-prostatectomy-for-localized-prostate-cancer
These are some of the FDA approvals for TULSA -
510k Clearance for TULSA-PRO | Profound Medical
Yes, the TULSA-PRO device is FDA approved. In August 2019, the U.S. Food and Drug Administration (FDA) granted the TULSA-PRO 510(k) clearance

Profound Medical Receives U.S. FDA 510(k) Clearance for TULSA-PRO® Thermal Boost The first of the TULSA AI modules, Thermal Boost enables predictable, customized ablation at the prostate capsule
https://www.biospace.com/profound-medical-receives-u-s-fda-510-k-clearance-for-tulsa-pro-thermal-boostthe-first-of-the-tulsa-ai-modules-thermal-boost-enables-predictable-customized-ablation-at-the-prostate-capsule
Focused Ultrasound Foundation
https://www.fusfoundation.org › Blog
Aug 29, 2019 — TULSA-PRO is the first transurethral ultrasound device to earn FDA approval. It uses real-time MRI guidance ...

September 20, 2023 Profound Medical, Inc. Imen Ferchichi ...
accessdata.fda.gov
https://www.accessdata.fda.gov › cdrh_docs › pdf23
PDF
Sep 20, 2023 — The original TULSA-PRO® System was cleared under K191200. Subsequent changes to the original system were cleared under K202286 and K211858.