According to a media release issued by a Canadian company called Profound Medical on August 16, the US Food and Drug Administration (FDA) has approved the use of a system called TULSA-PRO for the “ablation of prostate tissue”. There appears to be no relevant information on the FDA web site — as yet.
Some of the claims made in the above-mentioned media release may not sit too well with the FDA, and we would point out that the approval of this technology for “ablation of prostate tissue” does not necessarily indicate that this new technique can be used to safely and effectively treat men with prostate cancer. Indeed, it seems likely that neither Medicare nor other payers will be willing to cover the costs associated with the use of this technique for treatment of prostate cancer until there are a lot more data available.
Profound Medical states that the FDA’s approval of TULSA-PRO is based on data from the TACT trial, which enrolled just 115 patients into a non-randomized, open label, clinical study. So while it is clear from the data in that trial that the technique is able to “ablate” (i.e., kill off a percentage of) prostate tissue, there appear to be no data beyond 12 months to suggest that the technique can actually reduce risk for progression of prostate cancer over time, and the normal follow-up period considered acceptable for proof that any treatment is effective and safe in the treatment of prostate cancer is at least 5 years and preferably 10 years (not just 12 months).
Because Profound Medical is based in Canada, it can make claims on its Canadian web site about the efficacy and safety of the TULSA-PPO system compared to other forms of treatment that would never be allowed by the FDA here in the US — and it appears to be doing this. It is very possible that the FDA will tell the company in no uncertain terms that much of the information on the Canadian web site cannot be used to market this system in the US because there are actually no head-to-head data that would support any of these claims.
There is no doubt that this technique could be used by “U.S. surgeons to perform prostate tissue ablation procedures indiscriminate of tissue type, including malignant and benign,” as stated in the media release issued by Profound Medical. However, that is very different from being able to claim that it can effectively and safely treat prostate cancer. We would warn men with prostate cancer (anywhere, not just in the US) that as far as we are aware there are no data as yet to support any suggestion that this technique can be used effectively and safely to treat prostate cancer.
The TRUS-PRO system is basically a procedure in which a combination of real-time MRI imaging and transurethral insertion of a robotically-driven directional thermal ultrasound delivery system (with closed-loop temperature feedback control software) to deliver predictable levels of thermal energy that can be administered to the entire prostate gland or or to a specific segment of the prostate gland, thereby “ablating” the targeted prostate tissue. However, …
There are several other ways in which this can already be done.
It is also important to appreciate the following:
- The TACT trial on which the approval of the TULSA-PRO system is based enrolled 115 men with prostate cancer who all received whole-gland ablation of the prostate. None of these 115 men receive partial ablation of the prostate.
- The 115 men enrolled into the TACT trial appear to have included
- 77 men with intermediate-risk prostate cancer
- 38 men with either low-risk or very low-risk prostate cancer
The implication of this is that many of these men (and particularly the ones with low-risk forms of prostate cancer) may well not have needed any treatment for their prostate cancer at all. It is also not entirely clear (yet) exactly how many of the men with intermediate-risk disease fell into the “favorable” intermediate-risk as opposed to the “unfavorable” intermediate-risk category.
What we appear to have here, therefore, is a technique that could be used to treat several different types of prostate condition in which ablation of some or all of the prostate tissue would be advisable (e.g., benign prostatic hyperplasia as well as other conditions). As far as The “New” Prostate Cancer InfoLink is concerned, however, it has yet to be demonstrated that this technique can be used safely and effectively for the treatment of prostate cancer. Furthermore, since we have no accurate, head-to-head, comparative data showing the relative efficacy and safety of this technique to other new techniques (HIFU specifically included), it is unknown whether this technique is actually any better that such other techniques — although we do not deny this possibility.
Filed under: Diagnosis, Living with Prostate Cancer, Management, Risk, Treatment | Tagged: ablation, energy, Profound, thermal, transurethral, TULSA-PRO, ultrasound |
THE "NEW" PROSTATE CANCER INFOLINK 
Fair and reasonable warning!
The sitemaster is to be complimented on voicing his reservations on these localized prostate cancer treatments. For those following posts on UroToday.com, which regularly reports comparison studies of pre-op prostate MRI findings with post-op whole-mount surgical pathology in which prostate MRI is shown to underestimate cancer volume by 2/3 , one wonders why anyone would anyone would opt for this kind of localized treatment or even offer it, since the treatment is based on what is seen on MRI.
Thank you again for reporting on this subject.
While the above information may be something worth knowing about, it may have downplayed the potential benefit of HIFU because it does appear that some experienced HIFU treatment centers are reporting good success. This may be due to any number of factors, including careful selection of patients, treating areas 1 cm beyond what is seen on MRI where possible, carefully monitoring patients post-treatment, etc. This subject is somewhat controversial so a prospective patient needs to do their homework.
Please keep in mind that this “Tulsa Pro” can also be used to treat whole glands, so issues regarding margins around individual lesions in these cases are not relevant. I compare this to radical prostatectomy with benefits that side effects are significantly lower (based on trial results)
Dear Mr. McKenney:
It is important to distinguish with great care between what any specific technique can or could be used to do and whether we have data suggesting that it is either appropriate or more appropriate than other, similar techniques that can be used to ablate prostate tissue.
We would again point out that the TACT trial discussed above followed the patients for just 12 months, so the long-term effectiveness of this technique — as far as I am aware — remains open to question.
I had Tulsa-Pro this year on intermediate- to high-risk 4 + 3 cancer. So far so good. Seems to be more exacting than the other treatments.
As far as using ultrasound to kill a cancer, I’m not all that sure whether the medium used to kill a prostate really matters that much. The important part is how exact it is in killing only the cancer and sparing what else can be spared. It appears to have been used in Europe since 2016. There are a number of roll outs this year in the United States, in California and New York, although only one doctor is doing it in Sarasota, and I believe one in Atlanta just started. As you can imagine, given the ease of the procedure (there is no surgery and it is over in one day), it’s pretty popular. Of course, proof is in the pudding, and only years of data will demonstrate its effectiveness.
Profound is starting a randomized trial of TULSA vs radical prostatectomy. It may be something for the site master to look in to and comment on.
Martin Cohen, MD:
I guess the TULSA-PRO manufacturer is desperate. After the Klotz trial showed 35% had biopsy-proven residual cancer in the prostate 1 year after whole gland TULSA-PRO treatment, you’d think they’d give up. Tellingly, they aren’t comparing it to SBRT, which had 1% residual cancer (in a high-risk patient) in the prostate 2 years after treatment, while maintaining very comparable toxicity and potency preservation.
The longest-running HIFU study is 21 years. The 15yr PC-specific survival compared to nomogram RP is 95% vs 99% for low-risk, 89% vs 98% for intermediate-risk, and 65% vs 85% for high-risk patients. Compared to 12-yr follow-up on SBRT, the % who do not require salvage therapy was 77% vs 97% for low-risk, 52% vs 92% for intermediate-risk, and 28% vs 88% for high-risk patients.
I think it’s time to give up on thermal ablation for prostate cancer – it has now been proven to be inferior to alternatives.