I was diagnosed in Oct. 2017 with Gleason score of 6 and PSA 5.8. PSA was gradually going up and up. Had blood work done June 6th 2023 for a shoulder surgery and PSA was 15.3 had a PSA test done on July 24th 2023 for fusion biopsy on July 31st 2023 and it went up to 18.3 (1 month jumped 3 points). I take 2 tamsulosin both at night before bed. My biopsy came back with 1 tumor being aggressive and Gleason score went up 4+3 .. Doctor said since there is only 1 tumor and its not close to the wall of the prostate he is suggesting HIFU.
I would greatly love advice, suggestions.
Thank you!
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jbsnv
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HIFU doesn't work. I think urologists who recommend it to patients outside of clinical trials should lose their licenses and face prosecution. There was a reason the FDA denied it for prostate cancer.
They are claiming that HIFU is a prostate cancer treatment. The FDA specifically rejected that claim. Then the manufacturers asked the FDA to approve HIFU for removal of prostate tissue (like a TURP) rather than as a treatment for prostate cancer.
This makes them criminally liable, according to this:
The false claims act is a civil, not a criminal, statute. Plus, from what I can find, hifu has been fda approved for ablation of prostate tissue. It doesn’t say only benign tissue. See the ucla website offering hifu for prostate cancer.
You may be right that it's civil- I am not a lawyer. But the claim HIFU pushers are making is that it is a treatment for prostate cancer. The FDA specifically rejected that claim.
Some hospitals are doing it as part of a clinical trial, and that's as it should be (although they should be running comparative clinical trials to such SOC PCa treatments as hypofractionated radiation).
If you are interested, here is a good history:
Here's a good history:
"Current FDA Approval Controversy and Guidelines
Prior to the 2015 FDA approval for prostate tissue ablation, devices failed to win approval for localized prostate cancer treatment due to lack of substantial clinical efficacy. The first application by EDAP TMS (July 2014) failed to win approval for Ablatherm Integrated Imaging HIFU System due to lack of clinical benefit. A nonrandomized controlled trial compared efficacy of their device to cryotherapy for low-risk PCa. The trial, which began in 2006, was terminated in 2010 due to inability to enroll enough patients, particularly in the cryotherapy arm. EDAP then conducted a meta-analysis of HIFU and cryotherapy results in the literature, plus a review of comparisons of a European HIFU registry with surgery in U.S. VA study PIVOT. FDA did not approve the device due to deficiencies and potential safety concerns including a 28% cumulative positive biopsy rate 2 years after HIFU treatment among individuals in the nonrandomized trial. SonaCare Medical tried to win FDA approval for the Sonablate 450 HIFU System based on an interim analysis on a multicenter, single-arm trial from the first 100 patients (200 planned) with recurrent PCa following EBRT who underwent whole-gland HIFU ablation compared with surgery or cryotherapy in the same postradiation setting. Assessment was made of BFS and NBR after 12 months and showed similar safety profile to surgery but was deemed too early to demonstrate any clinical advantage and the FDA committee advised the company to wait for trial completion.
Then in 2015, FDA approved Sonablate under a de novo pathway for tissue ablation, without specification of an indication for PCa. The de novo pathway was introduced in 1997 with the FDA Modernization Act and is an alternative to a lengthy and costly premarket approval process that requires stringent clinical data (that were lacking during the two prior applications for a specific prostate cancer indication). De novo clearance is predicated on three conditions: (1) a novel device or new intended use of an existing device; (2) a low- or moderate-risk profile; (3) no predicate (i.e., legally marketed device). Subsequently, Ablatherm then obtained 510K FDA clearance. FDA commented, “Clinicians, in consultation with their patients, should decide how best to use this tool.”
Despite some encouraging data, current European guidelines set forth by EAU-ESTRO-SIOG suggest HIFU use in nonmetastatic PCa as part of a clinical trial only. The American Urological Association (AUA) guidelines from 2007 (updated in 2011) made no suggestion of HIFU treatment for localized PCA due to the minimal amount of data available. Until longer-term follow-up studies occur or randomized control trials directly testing standard treatments to high-intensity ultrasound approaches, guidelines are unlikely to change. "
I read the cited article. As I said, the FDA has approved hifu for prostate tissue ablation. I didn’t see that approval forbidding use for PCa. Also, I thought doctors are allowed to use FDA approved drugs and medical devices “off label,” if using hifu to ablate a malignant prostate lesion is even considered off label. You may not like hifu, but that doesn’t mean it is illegal or even malpractice for a doctor to use it. If I recall correctly, weren’t some doctors using avodart and metformin “off label” to either prevent or treat recurrence? I could be wrong about that.
But proponents are promoting it publicly to patients as a treatment for prostate cancer. It's intentionally deceiving patients that is wrong (whether civil or criminally). They are telling patients it treats prostate cancer. Many have websites that lure patients like this:
I get it. It is being advertised as a treatment for PCa. You have not cited anything in the FDA approval that forbids using hifu to treat PCa or overrides off label use, if it is actually off label. Do you think that the Mayo Clinic or MD Anderson are engaging in improper conduct by offering hifu as PCa treatment for certain patients?
It could say that hifu is guaranteed to cure PCa or suitable for all patients. No treatment is.
You are certainly free to reject hifu in favor of a different treatment (I did), but saying to offer it is creates either civil or criminal culpability is not correct, IMO, unless practitioners overstate the outcomes or guarantee a cure.
If the FDA had the resources, it would send cease-and-desist letters to doctors who lure patients into such substandard treatments, just as the FDA sends such letters to supplement mfrs who make unfounded claims. A doctor can prescribe an approved device or drug off-label, but cannot promote it as a treatment for a disease that the FDA has specifically rejected.
You asked: "Do you think that the Mayo Clinic or MD Anderson are engaging in improper conduct by offering hifu as PCa treatment for certain patients?" Yes! Definitely! The FDA has specifically rejected it as a treatment for prostate cancer.
The FDA rejected hifu for prostate cancer and then subsequently approved hifu for ablating prostate tissue which absent a specific prohibition would IMO include malignant prostate tissue. You continue to ignore that fact. All of the major hospitals seem to offer hifu to treat certain PCa patients. Since you quoted Harvard (from 2014) here is what Harvard had to say last month.
Yes, they can take out prostate cancer tissue too, but they can't promise it as a treatment for prostate cancer. I don't understand why you are blind to the distinction.
I think we will see class-action suits coming in the next few years, as patients, who have been enticed by unfounded promises ("a treatment for prostate cancer") from unscrupulous doctors and institutions, get together and make some noise. I think greedy institutions are as prone to lying to patients as greedy doctors in private practice are.
Your “distinction” has no difference. In this context, “treatment” is a method of attempting to mitigate a disease. The goal of all cancer treatments is slow down cancer and hopefully to eliminate all cancer cells and cure the disease. You can surgically remove a tumor, try to kill it with radiation or drugs, you can ablate tissue, or some combination of those. To treat a condition does not guarantee the result.
Do you think for one second that someone getting hifu doesn’t sign an informed consent document stating they have been informed of the risks and possibility of failure, just like all treatments? Anyone can sue anyone, but that doesn’t mean they will win.
And I don’t know what it means to say they “promise” it’s a treatment. It is a treatment, that may or may not result in a cure or remission. Whether or not you or I would choose this method doesn’t mean others would or wouldn’t.
I never mentioned curative treatment - you did, setting up a strawman argument. When people resort to strawman arguments, I take it that they have nothing useful to say on the subject.
You cited the FDA’s initial rejection numerous times. That rejection was based upon, among other things, the failure to demonstrate an acceptable cure rate. IMO, your argument incorporates that by repeated reference.
That said, I see nothing to be gained by continuing this. You clearly have more knowledge about PCa than I do. But you have not convinced me that hifu has no place in the discussion of PCa treatments.
You should look at several whole gland radiation treatments, and you do have time. I was diagnosed with 4+3 (and yes, would not consider HIFU per Tall_Allen), and considered SBRT among several options. I decided on LDR brachytherapy because it was one and done. But could have gone any of several routes. All have equal outcomes, just depends on your preference and your particular situation (i.e. you may not be a candidate for a particular treatment, like LDR). Read my posts and you can see more about it.
A matter of interest......did the urologist order an MRI, and see only one prostate lesion? Otherwise, how would he know there is only one tumor???????
That would perhaps explain his mention of focal therapy....sadly, studies show a greater probability of failure with such focal treatments. Some men still proceed, hoping to land in the success group, and feeling that they can always have surgery or radiation later ?
Hi Lizzo, I was expecting him to say seeds but when he said HIFU, I forgot all about that procedure and said that makes sense but when I posted the question here, it's a BIG NO WAY .. and I am so happy that Ibelong to this group!!! They probably saved my life!!!Thank You Everyone!!!
Here is a good website to compare odds of cure for the major treatment paths. You have to determine your stage, low risk, intermediate, or high risk (risk of recurrence). So if you are intermediate, pull up the intermediate chart and you can see the odds of 10-20 yr survival, etc. based on the treatment you pick.
It is best viewed on computer or just print it on paper. Not so viewable on phone.
To make the graphs easier to read, i drew a dot on the endpoints of the elipses, and then drew a line through the dots. This turns the elipses into lines.
Also be aware the the graphs don’t show any salvage radiation benefit. This would boost the surgery odds up a bit.
Also beware, this is a very dysfunctional industry from my view. Loads of bad info mixed in with the good info. Same with the docs. Some of them are more dangerous than the cancer.
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2nd Opinion Recommendation for North Carolinia/Virginia/DC
Uro and Surgeon Recommending Focal Cryoablation
Diagnosed 4+3
ADT duration for high risk with Cribriform
Here we go.......
