Whole gland TULSA-PRO outcomes: Is it... - Prostate Cancer N...

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Whole gland TULSA-PRO outcomes: Is it time to give up on thermal ablation for prostate cancer?

Tall_Allen
Tall_Allen

Full-gland TULSA-PRO seems to treat PSA without eradicating the cancer. In about a third of favorable-risk patients, the cancer remained viable in spite of the thermal ablation. We see that compared to whole-gland SBRT, it is less curative, Severe (requiring intervention) acute urinary toxicity is higher with TULSA-PRO, although late-term Grade 2 urinary toxicity is lower (not severe for either therapy). Rectal toxicity is not an issue for either therapy. Potency preservation is good and about equal for both.

It is hard to see why anyone would choose TULSA-PRO over SBRT. While focal ablation may incur less toxicity, the local recurrence rate will be higher. This trial suggests that TULSA-PRO is inferior, although only a direct randomized comparison could prove that.

prostatecancer.news/2021/03...

36 Replies

Thank you for your contribution. I have to admit this is disappointing news.

I was hopeful that Tulsa could be used as a treatment that could preserve QOL, kill all of the PC and avoid the harmful effects of radiation.

I know this question is off topic but when I was getting treated at Mayo with Proton Therapy (pencil beam) I asked the resident Oncologist what percentage of patients get a secondary cancer from radiation treatment to the prostrate.

He told me about 1 and 20,000. I was wondering if there was any research papers that talk about that.

It seems to be very small, and is incredibly difficult to know. Here is what I've seen:

prostatecancer.news/2016/08...

Thank you.

In the chart in your article, I do not understand the second line. Shouldn't the biochemical recurrernce free survival rate of TULSA-PRO be 65 percent, instead of zero?

TULSA-PRO "treated PSA," so the bRFS was zero. However, biopsy showed that 35% had live cancer cells in the burnt-out husks of their prostates. Those cancer cells did not leak much PSA out into the serum in the year of follow-up. They would have to re-grow their own blood supply to do that (which is what cancer cells all do). So a treated patient may think he's in the clear if he relies on PSA to tell him if his cancer is cured.

So, BRFS is only determined by PSA level? I had assumed that biopsy (for non-RP) or PET imaging could also determine the existence of post-treatment cancer. That confuses me further.

The "B" stands for "biochemical" (i.e., PSA). Mp MRI and Biopsy can detect a clinical recurrence, not a biochemical recurrence. Usually, a biochemical recurrence is a first signal that a clinical recurrence is suspected. But that is not what happened here - they detected a clinical recurrence (because those diagnostics were built into the trial protocol) even though there was no biochemical recurrence

Got it. Thank you.

I certainly found this out after doing Tulsa Pro. I followed Tulsa Pro with a PSMA PET scan at three months. Involvement in the seminal vesicle lead me to proceed with ViewRay 5 day SBRT which was a) much easier and did not require a catheter, and b) covered by Medicare.

tdnh
tdnh in reply to mperloe

Hello, Do you mind sharing where you had the TULSA performed and your diagnosis prior to treatment? I was about to drop $30K on the procedure to do a focal treatment. Thanks!

mperloe
mperloe in reply to tdnh

Spent $30k with Dr. Scionti. I had PSA 3.99, GL 4+3 in one core. I think any GL 7 needs PET first.

Disappointed to read these results.

Focal laser has reasonably good results, at least so far, without the side effects.

Tall_Allen
Tall_Allen in reply to Daveofnj

Unfortunately, FLA does not have reasonably good results. Results are similar to HIFU, cryo, and all other kinds of thermal ablation:

"Focal Laser Ablation (FLA): (Update 5/2019) Chao et al found that 8/32 (25%) had an mpMRI suspicious for cancer in the ablation zone within 2 years after FLA (Median time to positive mpMRI in the ablation zone was 6 months). All were confirmed by biopsy. Only one of those patients had low volume GS 6. 24/32 (75%) had an unsuspicious mpMRI, but biopsy at 2 years after FLA was nevertheless positive in 9 of the 14 men (64%) who had a biopsy. So 17/22 men (77%) had a positive biopsy in the ablation zone after 2 years. Change in PSA did not predict a positive or negative mpMRI or a positive or negative biopsy.

In this study, MRI-detected cancer was found in 10/27 patients after 12 months, with cancer found in the ablation zone via biopsy in 3 patients. Cancer was found in the ablation zone in 2/9 patients (22%) in this study, 7/10 (70%) patients in this study that used a targeted biopsy, and 4/12 (33%) in this study. In one study, 2/13 (15%) had residual cancer within the ablation zone, but only 13 of 23 patients had a targeted biopsy. Knull et al. compared the pre-operative mpMRI images with MRIs obtained immediately after FLA in 23 lesions. They found that FLA did not completely overlap the intended ablation zone in about half of the lesions, and those tumors extended a median of 0.9 mm past the edge of the ablation zone."

prostatecancer.news/2016/12...

(you can read the studies in the links in the article. HealthUnlocked does not allow hyperlinks.)

Daveofnj
Daveofnj in reply to Tall_Allen

FLA doctors say that surgical technique has improved with experience. They acknowledge that in the first few years of practice the margins ablated around lesions were too small, leaving microscopic residual disease in many cases. I'd like to see the results of procedures done in the U.S. since 2017, when surgeons started to take much wider margins.

On inspire.com there's a discussion forum on which many thousands of men who've had FLA discuss their results. The vast majority report good outcomes. Yes, there are some who've had recurrences and some who've have had a second FLA.

Tall_Allen
Tall_Allen in reply to Daveofnj

It is silly to point to anecdotes on a patient forum (a self-selecting sample) as evidence.

Several of those studies in the article were done in the last few years. Look at them. You seem to be suffering from confirmation bias, screening out results you don't want to hear. Only real evidence matters, not wishful thinking.

Daveofnj
Daveofnj in reply to Tall_Allen

The most recent information on patient outcomes seems to confirm my bias and lends additional credence to patient anecdotes on the web.

The latest publication provides 10-year follow-up results from a Phase 2 trial. These results were published April 2020 in the Journal of Urology. The authors conclude -

"At ten years, the metastasis free survival rate is 99%, the prostate cancer specific survival rate is 100%, and the overall survival rate is 98%. Ten year outcomes data indicate that outpatient, trans-rectally delivered MRI-guided laser focal therapy for prostate cancer has similar oncologic control as whole-gland therapy without theassociated morbidity. In 94% of the treatment naive patients, whole gland therapy was safely avoided. Focal treatment of prostate cancer may be an attractive option in a subset of men appropriately risk stratified. "

"Inclusion criteria were aged ≥45 years; clinical stage T1c or T2a; Gleason score of 7 (3+4 or 4+3) or less; ≤3 biopsy cores with prostate cancer; and a PSA density of ≤0.375."

Tall_Allen
Tall_Allen in reply to Daveofnj

Great. Do you have a link?

The part you left out says:

"Of the 122 men that underwent 6 mo. biopsy of the treatment site, 32/122 (26%) of men were positive and clinically significant, while 71/122 (59%) of men were negative. The remaining 18 men (15%) were positive but clinically insignificant. In addition, while most of the positive results were of marginal recurrence, 6 men (5%) had clinically significant incidence cancers. "

auajournals.org/doi/pdf/10....

Who in his right mind would pay for a therapy that only cures 59% of the low and intermediate risk treated men. You have further proved that any kind of thermal ablation sucks.

Beware of being blinded by confirmation bias.

Maybe HIFU is usable for these two patient groups: (1) men recommended to AS but the patients want treatment(2) men who have been treated with radiation and have had a relapse

Tall_Allen
Tall_Allen in reply to Gemlin_

Perhaps. But is there any advantage over SBRT for AS vs focal ablation for AS?

prostatecancer.news/2017/01...

And salvage focal ablation has given inferior results to salvage brachytherapy or SBRT:

prostatecancer.news/2017/09...

Some of the doctors have lately been using Tulsa-Pro primarily for hemiablations or partial ablations, which tells me they believe that ablating the whole prostate may be a bit much for the machinery. I think the trials REQUIRED whole ablations. The thing about whole ablations is there is a lot of prostate to get rid of and if you leave any, it might be the part that has some cancer in it. Which is what Scionti suspects caused my Tulsa-Pro to fail. Of course, the 4+3 or the cribriform morphology or intraductal might have had a hand also. So for people like me, I suspect the failure rate is more like 1 in 2. or more. One of my well known urologists told me he considers these "pretreatments". HOWEVER, I feel Tulsa-Pro has been and will be useful for many people that have the extra cash around to avoid radiation or surgery and buy some time and for some it likely provides a permanent cure. Of the 3+4 recipients, 2 out of 3 feel pretty good about their treatment. and these numbers just include the recipients of "whole" ablation. I personally know some that have had it, both whole and partial, and are very satisfied with it. I wouldn't throw the baby out with the bathwater with Tulsa-Pro just yet.

Tall_Allen
Tall_Allen in reply to Anomalous

If it worked so poorly when the whole gland was ablated, it would work even less well for hemiablation or focal ablation.

They didn't leave any prostate - the prostate volume was just 2.8 cc after ablation (vs 40 cc before)- it was just a burnt-out husk.

The people who are "satisfied" with it - compared to what? Doctors do a great sales job on it, and a lot of patients are drinking the kool-aid. .Look at your own experience! making excuses for it (conveniently provided by your doctor)even after it failed you miserably. After reading the article - what is there to recommend it? Time to get rid of it and move on.

Anomalous
Anomalous in reply to Tall_Allen

my prostate was still 22cc, down from 38cc, according to the MRI I had done at Mayo, almost 10 months after the procedure, which doesn't sound right to me. and indicates to me that the ablative mechanism was not functioning properly with me. But yeah, i get my first ADT shot tomorrow, so i definitely am going to radiation. That's the big thing, or draw, so to speak; people don't want to do that ADT.

Hi, just read a post from 2 years ago. The person who posted said, "I’m taking 20mg of viagra every day and 100mg one or two times a week." Could this be?? I had a RP 9 months ago, I'm 59. My urologist does not recommend this high dosage every day. But I am curious if it is okay taking 20mg every day? And the 100mg every now and then, is that safe? Curious if anyone else has insight. Thanks.Wanted to ask you directly Allen, but could not figure out how to send a direct message. Had to resort to answer a random post like this one. Sorry.

Yes, nightly 20 mg and "as needed" 100 mg is pretty much par for the course. To send a PM, click on the "chat" button above.

After my RP, my surgeon recommended 20 mg sildenafil daily 6 days/week, and 100 mg on the seventh day. Either way I got headaches.

I get headaches from Viagra, but not from Levitra. I think everyone reacts differently.

Thanks for the tip!

As usual, you have provided us more up to date analysis of what treatment options are promising and what the side effects are. Thank you!

Thanks all of you!

Thank you for the information. Having been recently diagnosed, this was the treatment that seemed most appealing to me. Based on this data, I am now seriously questioning if it is even an option. I do not want to pursue something with low efficacy where the consequences are so significant. Even more so when it will cost $30k out of pocket.

I confess that this information has burst the bubble of hope I did have to somehow maintain QOL. I am beyond depressed.

The problem I have is that in addition to the cancer, I have had BPH for many years due to my 97 cc prostate. The BPH has been successfully managed with medication to date. However, as one's prostate does continue to grow, some other treatment could well be needed in the future.

My hope for Tulsa (or FLA) was that it would simultaneously take care of the cancer and the BPH issues. I may be incorrect but, I believe therapies like SBRT, Brachy, Proton, etc. are effective for PC but do not address BPH.

Thus, it seems like I am really screwed here. RP was the one therapy I wanted to avoid at all costs. I understand that the risks of RP are further compounded by BPH and the likelihood of a trifecta significantly decreases.

As a patient with BOTH PC and BPH, do I even have other options at this point?

Tall_Allen
Tall_Allen in reply to PCInPA

97 cc is far from the biggest I've seen. Both SBRT and HDR brachy monotherapy can be used on prostates that large.

ncbi.nlm.nih.gov/pmc/articl...

ncbi.nlm.nih.gov/pmc/articl...

LDR brachytherapy (seeds) is not often used on prostates over 50 cc, although there are reports of good results.

brachyjournal.com/article/S...

The American Brachytherapy Society guidelines on LDR brachy state: "Larger prostates, up to 100 cc or more, are technically challenging, but toxicity and cancer control outcomes are acceptable."

If there is a lot of urinary retention before treatment, the temporary inflammation caused by radiation may make it worse for a month or two. Sometimes the inflammation is so bad that a trip to the ER for catheterization may be required. After that, the prostate shrinks and urine flow is usually better than baseline. Sometimes to avert such acute problems, ADT is given for several months before radiation to shrink the prostate.

But RP will give instant relief from your BPH symptoms. Intraoperative blood loss can be a problem.

Liproca (an experimental antiandrogen) can be injected into a large prostate, shrinking it without incurring the side effects of ADT used systemically:

eu-focus.europeanurology.co...

I think FT is further along in testing, and an NDA has been submitted:

prostatecancer.news/2020/04...

I was strongly considering Tulsa but opted for surgery. One missing ingredient seems to be the unknown REAL Gleason score. My 60% 4 Gleason 7 found with in bore biopsy was upgraded to a 9 after RP. How many are getting Tulsa on suspected favorable that was misdiagnosed and therefore more aggressive?

I'd have no problem with thermal "ablation," even for high Gleason scores, if it actually destroyed the cancer - but we have convincing proof that it doesn't. I put "ablation" in quotes, because it is an attempt at thermal ablation rather than an actual destruction of the cells. I know Gary Onik is trying combining thermal ablation with immunotherapy. That makes sense to me - the attempted ablation released many cancer antigens. If the rest can be cleaned up with immunotherapy, that might have better results.

Tall_Allen wrote >>> " ... I know Gary Onik is trying combining thermal ablation with immunotherapy. That makes sense to me - the attempted ablation released many cancer antigens. If the rest can be cleaned up with immunotherapy, that might have better results... "

As mentioned numerous times, I AM one of Dr. Onik's EARLY cryoablation/immuno injection GLEASON 10 patients; HOWEVER, I BEGAN TREATMENT WITH SURGICAL CASTRATION and have been receiving Cypionate injections beginning 1 month after the immuno injection. ONLY TIME will tell if I chose well or not but as of *TODAY* and being 6 years this week from initial biopsy, I am doing well.

BTW, I prefer to refer to my "thermal ablation" as "MY SUMMITTING OF MT. EVEREST" since cryoablation is freezing to death instead of the use of heat/radiation or going to hell.

I agree

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