Cryo joins HIFU, FLA, and IRE as substandard focal thermoablation therapies. Aker et al. reported (below) that on biopsy 18 months post-treatment, 35% still had clinically significant prostate cancer (only 46% had no prostate cancer), and that neither MRI nor PSA were good indicators of treatment failure.
Someone in my last support group meeting said they were going to do HIFU because "it only has a 25% recurrence rate" and "you can still do any of the other treatments later if you need to."
That didn't sound right to me, but I didn't say anything because I wasn't familiar enough with the treatment.
It's funny because when he was talking about it you could tell what the marketing pitch was. It's good marketing when you can sell retreatment as an advantage.
It's difficult to generalize from studies like this. Is the group considered a homogenous group or contained subjects who are very different than your situation. When studies simply categorize patients as receiving radiation, we have to ask HDR, LDR, VMAT, ViewRay, Cyberknife or Proton. They are not the same. How where the patient's staged? Was a PET scan done for higher Gleason scores? If not, disease outside the gland may be missed. If surgery was done, how much experience does the surgeon report? Will lymph nodes be removed or treated?
One problem is that we each face a myriad of different variables that can affect the outcome. The single most important factor is finding a physician who you trust to digest the literature, who understands your situation and concerns, and can offer a full range of treatment options.
AI is beginning to appear in studies evaluating whether it is a useful tool to read mpMRIs and biopsies. Perhaps a Prostate Cancer AI Navigator will help us determine the "best" option for each of us.
all we can do is do our best with what we have NOW. If you have a secret for finding a " physician who you trust to degest the literature", let us know. Kaiser experienced urologist and RO will not talk about any numbers re either probability of "successs" for my case nor probabilities of various SEs. I have no idea where I might find someone who is better at that here in this area. A uro at OHSU brushed me off when I mentioned perhaps more cores should be taken from my 80 cc prostate...yes, I had read a bunch of studies on that topic. She also refused to allow administration of propofol light sedation for my biopsy.....and then procedure was stopped when pain was unbearable.....she was supposedly the numero dos PCa urologist at OHSU....mentored by numero uno the dept chair.....he was not available.
I am both terrified of metastatic PCa and also of an immediate loss of QOL from a treatment...now age 74, and 4 years since first referred to uro at 70 for 7.5 PSA.....1 core of <10 % 4+5 found in one of 12 random cores...all 6 cores taken from a PIRADs 5 were benign supposedly. one other core was 3+3, <10%.
So these Docs won't enter into any numbers discussion, so I look at something like PREDICT nomogram used by NHS I believe, and that indicates an increase, but not large, in CSS for those who do initial treatment vs those who decide on WW....whatever that means, perhaps wait until definite signs of metastasis????
Very disillusioned about what passes for "healthcare"....not feeling it!! Perhaps the Docs are simply overworked and insufficient time to be what I think they should be???
Hello Allen. I have been following you (and some other members) because of your high knowledge and understanding on Protate Cancer and especially on BAT. Your knowledge and participation is impressive. I would like to thank you very much indeed on my behalf.
I can only read and try to understand "Results" and "Conclusion" parts of such articles because my English is really not good enough. I am very sorry if I made a mistake but as far as I understood from that article is :
- In 76%, the biopsy revealed no csPCa (clinically significant prostate cancer. I don't even know what it means, but it gives me shivering. Sounds like cancer is still there but not significant enough.)
- In 65%, continued biopsies revealed no csPCa.
So, I think I got it wrong. But it looks like 65% of the patients were successfully treated with Cryotherapy and this percentage looks good to me. Do you mean 65% is too low? Or did I misunderstand something?
Surgery and radiation have a much higher success rate as a single treatment is what he is saying , I believe.
I ave no problem with clinics/hospitals offering such abation treatments...but only when full disclosure is made......in other words, patient should be informed of better success rate for surgery and radiation ,and shown side effect comparison for ablation versus surgery and radiation.....otherwise, patient cannot make "fully informed decision". Sould an insurer pay for such a less successful treatment? That is a different discussion!!
Also it would be great if unproven treatments, ie those not supported by IRB approved peer reviewed reports, be part of a clinical trial. It's great when we get to share what worked for us. That is far from suggesting that a particular approach should be considered by all.
Yes, 65% is too low. And only 46% had no detectable cancer, which is awful. By comparison, for similar patients 2 years from SBRT treatment, 99% were recurrence-free.
143 men with unilateral csPCa were enrolled in a prospective, observational trial of outpatient PGA-cryotherapy. *Treatment was a 2-cycle freeze* of the affected prostate part. Participants were evaluated with MRI-guided biopsy (MRGB) at baseline and at 6 months and 18 months after treatment. Absence of csPCa upon MRGB was the primary endpoint; quality-of-life at baseline and at 6 months after treatment was assessed by EPIC-CP questionnaires in the domains of urinary and sexual function. ......... "
Dr. Gary Onik performed a 3-cycle freeze with PASSIVE THAWING between cycles thus providing a longer time for procedure killing my GL10 PCa located in the right half of my prostate. He also used enough probes to Cryo an entire prostate allowing for a slower and more accurate freeze ball boundary to develop and hold.
" ....... 1 INTRODUCTION
Cryotherapy, the focal application of ultra-cold temperature, is the original modality for partial gland ablation of prostate cancer (PCa). Onik and colleagues described the freezing of unilateral PCa using argon gas in 2002.1 Subsequently, these authors introduced the term “male lumpectomy”,2 referring to the localized ablation of a tumor in the prostate, analogous to Fisher's lumpectomy for breast cancer.3 Interest in focal therapy of PCa, that is, partial gland ablation (PGA), may be dated from that time and is now increasing rapidly.4 However, randomized trials of PGA-cryotherapy (or any other form of PGA) are not currently available.5 ....... "
Now let’s assume you do indeed have an index tumor, and you were able to accurately delineate it somehow, the next question becomes: Can focal therapy be used to completely ablate the tumor? So far, the answer seems to be – not completely. In some studies, treated patients had MRI-guided biopsies of the ablation zone within 6 months of treatment. Cancer was found in the ablation zone: ...... "
Dr. Gary Onik did not employ a MRI- guided biopsy for my GL10 biopsy but instead performed his Saturation Transperineal 3Dimension Prostate MAPPING Biopsy that does INDEED provide for delineation.
That is sample size of one The article doesn't say it never works. Just that it has a significant probability of not working. Ultimately, we are all playing a cosmic statistical game, and choose paths where there is best probability of success. I know someone with 3+4 that chose no treatment and has been alive for 20+ years. Probably a very low probability event, but he played that game.
actually, if you search out the studies, his result is the norm for 3+4 !!!!!!!!!!!! But Docs won't tell you that, IMHO. GOOGLE 2017 prostatectomy observation.
most of these look so good on paper, but then most things do until the fact checkers come into play. It’s the world today 💵
I had excellent results with full gland HIFU in 2016. No ED, no incontinence. No disease progression. No problems. I guess I must be a hell of an outlier. And yeah maybe FOCAL ablation isn't such a swell idea. Only leaves the job half done. A half-fast treatment option if you asked me. Real surgeons like mine insist on and do full gland ablation which does require prior TURP surgery.
I can provide my own data point. 5 1/2 years post full gland HIFU. Five years free from ADT after the initial 6 month injection. It is thermal ablation. Prostate tissue gets roasted and ablated. Why would there be adverse long term effects when done properly by an experienced practitioner? The ablation is accurate, focused, and with position and temperature feedback during the process, affecting only prostate tissue unlike external beam ionizing radiation that has to pass through and affect/burn tissue outside the prostate in order to get to the prostate. This 'long term effects' issue just seems to me to be an argument against any new treatment that practitioners without the skills or investment in the apparatus raise. Of course, when we are dealing with prostate cancer, there is always the possibility that as yet undetected metastasis may have already have occurred. The 'cat' may have already escaped the bag. That's not on HIFU or any other treatment that targets the malignancy within the prostate like radiation or radical prostatectomy. No such treatment is guaranteed in that sense. That's how/why recurrences happen. For intact prostates that received only focal ablation, the un-ablated, non-cancerous tissue can always subsequently turn cancerous or maybe the biopsy missed the cancer in that presumed non-cancerous region. That's why I recommend full gland HIFU, not focal. A real evaluation of HIFU should be based on full gland ablation, in my opinion.
Congrats on your good results! I agree, but would do only with proof of its probability of one and done long-term success. AN n=1 is insufficent of course. also need SE profile for full gland. Did you have TULSA PRO HIFU? What did your Doc provide inthe way of data for full gland ?
I imagine focal is done because lowers probability of serious SEs compared to full gland...but yes, also lower success rate. I have read horror stories about men who had HIFU......nothing is risk-free we all know!!! any treatment can have varying results dur to practitioner skill level variability. some things hapeen even with the best!!!!
Had conventional probe up the kiester HIFU. I researched HIFU and had a long conversation with the HIFU surgeon before I signed on. I understood the process. I didn't need data from the surgeon, I just wanted to know about his experience with the procedure and he had plenty, having practiced outside the US before it was approved here. The procedure causes temporary swelling which necessitates the use of a supra-pubic cathether. TURP (roto-rooter) surgery is also recommended and I already had that years prior to being diagnosed with prostate cancer. As far as HIFU choice? I wasn't a candidate for RP after TURP and I didn't want something so invasive with so many quality of life ruining risks. I was steered toward external beam radiation but I had seen too many radiation horror stories to want to go down that road. Besides, after BPH for years my bladder was in sad shape and I anticipated much difficulty in the requirement to have a very full bladder in order to receive, count em, 45 eff'ing radiation treatments. Drink the quart of water before every radiation treatment. I just couldn't do it. One and done with HIFU vs 45 trips to the radiation facility. In my mind HIFU was the safest path in terms of treating the disease with minimal quality of life risks. I am very happy with the results. As far as your concerns about the risks of HIFU you should know that over 20,000 men have had this procedure world-wide. It is not experimental.
I appreciate and respect your decison...of course. You did your own research.....would I easily find some conclusive/convincing studies by using Google or pubmed.com ? what do you advise in terms of search words? Of course we'd all be very appreciative if you could provide some link to a conclusive study on whole gland treatment. Yes, surgery and RT have pros/cons...what doesn't???
There is a HIFU provider here in Portland who also practiced previously in another country. Maybe I'll find some data on his website? I don't think they will do HIFU for high risk patients?
Having extensive experience with real-time MR thermometry, cell death is at best guess an estimate. Uterine fibroids treated with focal therapy come back in 6-18 months. While thermometry suggests we killed all the cells, biopsy could show otherwise.
I don't think you can ignore misdiagnosed external disease as a cause for failure. Sensitivity of PET is 50-60% sensitive to detect LN involvement meaning you will miss a lot of lymph node that actually have disease. Increasingly new tissue genomics or liquid biopsies will help us better pinpoint those at risk.
While I can't rule out of hand the possibility that HIFU may work better in one surgeon's hands than another, it stands to reason that a therapy with such a poor success rate should NOT be considered the standard of care, and that bad results should NOT be compared with others receiving the same therapy, but with others receiving the standard of care. I am likewise not familiar with what exactly the purview of the FDA is with regard to this particular medical device. But if regulators are not on top of this, perhaps negligence lawyers should be.
The FDA rejected HIFU for the treatment of prostate cancer. Then the HIFU mfrs asked the FDA to approve HIFU for the removal of prostate tissue (like a TURP). It does that, so the FDA approved it for that purpose. But once it was approved for that purpose, unscrupulous doctors began using it claiming to cure prostate cancer. I agree with you that any doctor that doesn't obtain informed consent from his patients should be sued. I suspect that they rarely do that.
Oh and I've been taking metformin and all the good prostate cancer inhibiting supplements that you consider useless. I just got my PSA result back: 1.6. It was 1.8 six months ago so situation very stable. I am 5 1/2 years post full gland HIFU surgery.
BTW, my HIFU surgeon never claimed it was a cure and cautioned that he couldn't guarantee 100% success. I imagine all radiation oncologists would say the same.
The FDA, dropping the ball again. I suppose off-label use is permitted for pharmaceuticals, so the same would apply for devices. But it stands to reason that if you're using it for a non-approved purpose, you'd best have the evidence behind you. Somehow my grandfather's Yiddish opinion "courva n' goniff" (prostitutes and thieves) comes to mind.
The FDA is constrained by the law, although they could go after the unfounded advertised claims. Insurance generally won't approve it, but unscrupulous doctors insist on cash (about $25,000 for the first treatment, and it sometimes requires multiple treatments). I met one guy where his doctor treated him with HIFU for BPH (which was covered by insurance), and then took him for $20,000 cash for a PCa treatment. Double-dipping. The guy was offended when I told him to find a new urologist - con schemes work best when the mark is convinced of it.
Just asking this even though not at the point of needing further treatments: IF after radiation followed by 2 sessions of HDR pca pops up with no Mets would any of these treatments be a viable choice? Of just an RP?
You could consider them. I've heard that Dr. Aharon Feldman at Henry Ford in Detroit has used MRI Linac to treat recurrent lesions confined to the prostate that turn up after IMRT
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The article doesn't say it never works. Just that it has a significant probability of not working. Ultimately, we are all playing a cosmic statistical game, and choose paths where there is best probability of success. I know someone with 3+4 that chose no treatment and has been alive for 20+ years. Probably a very low probability event, but he played that game. 
Biopsy Question: Suspicious for focal intraductal carcinoma
Salvage focal HD brachytherapy 
Prostate Cancer Will Recur in 40%-50% of Patients After Initial Treatment
Focal Therapy
PATH REVIEW FROM MSK REREAD IDENTIFIES FOCAL\" EPE\" EXTRAPROSTATIC EXTENSION.
