The Cleveland Clinic Sucks: About... - Advanced Prostate...

Advanced Prostate Cancer

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The Cleveland Clinic Sucks

gusgold profile image

About 2 years ago I tried to get into the ProstVac Trial at the NIH. At the time my PSA was .2 and one of the study researchers said that was to low and the minimum PSA had to be 2. About 3 day later she called me back and said they would lower the requirement to .8....she said the trial was still open and to call back when my PSA got to .8...but get was OK that I was not Castrate Resistant. She also told me she was impressed by an Onco at The Cleveland Clinic..I am on Xtandi Monotherapy and wanted to try Provenge. I called and made an appt. with the Onco at The Cleveland Clinic. I refer to as Dr. Smuck. When Dr. Smuck walks into the office he jumps all over me for being on Xtandi Monotherapy. He said I don't know how you got Xtandi because you are supposed to be on Lupron until it fails, and you are castrate resistant, at which point you add Zytiga or Xtandi. I also told him about Dr. Myers and he said Dr. Myers was a quack. As far as Provenge goes he wants me to drop Xtandi and go back on Lupron until it fails and I am castrate resistant. When my PSA reaches 2 call him back and they will do a scan and then prescribe Provenge. I asked him wouldn't Provenge work better if I was not castrate resistant, he agreed but said they can not deviate from their protocols. Dr. Smuck stated The Cleveland Clinic is the top PCa hospital in the U.S.....but check this out, they do not offer the PSMA Scan and that is why I need a PSA of 2. Anyone know of a way to obtain Provenge without being Castrate Resistant outside of paying $100,000


22 Replies

This sounds more like the older approach. What did you do?


I go to Cleveland Clinic...drop a name (or give a description), please...concerned as I am a newbie, and like the guy I have so far. I participated in a clinical trial with apalutamide there with him and it went well.. Doubt it was my guy, since he put me on Zytiga and Lupron (bone met) when I was found to be stage 4......actually, MD Anderson is supposed to be #1 I believe... Thanks for posting....


Provenge is a Procedure, that uses materials that are drugs at some point in the process.

You can try the Right To Try, Law---but you are not close enough to death. No Gators yet, One Bull Shark, and One Stingray.


I understand your perspective. I would very much like to get my hands on Provenge. it makes total sense that Provenge would be more effective early on rather than late on. I recall at the LA prostate conference last year that there was some data that strongly supported this intuition. I read that Provenge is opening up in China. It might be an affordable option relative to the 90 k or so currently out there. I believe a round trip ticket to Shanghai these days can be had for a grand or so.


Looked around at trials....all say castrate resistant...try calling the company--maybe they have something in Europe or Canada in trials...

From the info on website, if PSA <22, increased median survival time by an additional 13 months...with your low PSA, who knows...Good luck...


It sounds reasonable to me. Provenge is only approved for mCRPC.

Schwah profile image
Schwah in reply to Tall_Allen

What sounds reasonable. Using Provence early or waiting to be castrates reaistant ?


whatsinaname profile image
whatsinaname in reply to Schwah

For sure, using Provenge early before one becomes "castrate resistant" is the way to go.

Provided, Provenge does not cause any great harm to one when one is "castrate sensitive" and takes the treatment.

No reason, it seems to me, why Provenge should be administered ONLY when the odds of survival are lowered. Of course, that is what current STANDARD OF CARE (SOC) prescribes. And, which is why one is soooo skeptical of SOC :-)

Absolutely, agree... decreasing tumor burden, circulating cells, etc... earlier in the process makes sense and some MD's are becoming proponents of that stance...Hit it while it is weak makes sense to me....if you can get some radiation first, it may work even better. They are trialing that concept.

Tall_Allen profile image
Tall_Allen in reply to Schwah

It sounds reasonable to take Lupron with Xtandi until we know if it can function just as long as a monotherapy (there's a clinical trial of that I think). Xtandi with Lupron is not approved for mHSPC but is the subject of one of the STAMPEDE trials (meanwhile Lupron+Zytiga is approved). So far, Provenge was not effective for HSPC:


As we learned from CHAARTED about docetaxel, earlier isn't always better (although it often is). Sometimes you got to fish when the fish are biting.

From your study:

Results: Median time to BF was 18.0 months for sipuleucel-T and 15.4 months for control (HR = 0.936, P = 0.737). Sipuleucel-T patients had a 48% increase in PSADT following testosterone recovery (155 vs. 105 days, P = 0.038). With only 16% of patients having developed distant failure, the treatment effect favored sipuleucel-T (HR = 0.728, P = 0.421).


The primary endpoint, while reasonably selected, was also arbitrary. There are no data to suggest that reaching a PSA concentration of 3.0 ng/mL following a brief course of androgen suppression therapy is or is not predictive of subsequent development of metastases or cancer-related death. At the time this study was designed, relatively little was known about appropriate endpoints in the setting of PSA-only relapse after radical prostatectomy. Regrettably, relatively little progress has been made in this area and the field continues to struggle with the design of studies in this patient population. One area of marked progress is the increased understanding of the prognostic importance of PSA kinetics in general and PSADT specifically. PSADT has been shown to be the single strongest predictor of prostate cancer related mortality in this patient population (21–26).

Again: PSADT has been shown to be the single strongest predictor of prostate cancer related mortality in this patient population (21–26).

There are several issues with using this study. Individuals were given ADT prior to study. I do not believe they were given during study. It was also a small cohort. Please see the conclusion as well:

Conclusions: No significant difference in time to BF could be shown. The finding of increased PSADT in the sipuleucel-T arm is consistent with its biologic activity in ADPC. Long-term follow-up will be necessary to determine if clinically important events, such as distant failure, are affected by therapy

They defined BF as a PSA>3, and if you look at the Figure 3--the PSADT was clearly superior for Provenge. Now, how would it work with ADT combination. I am unaware of studies that did both and looked at time to castrate resistance. Also, there were individuals who took much longer to get to PSADT in the Provenge group. Consequently, the question remains as to whether there is a subgroup that has a much greater response to Provenge than others. Once again, small cohort to draw conclusion on an arbitrary checkpoint.

To say the fish aren't biting and generalize it to all fisherman would, in a word, be to say all fisherman are equal in talent. This is not true.

When one needs a fish (ie: extend life/ cure) , then one will likely look at a variety of possibilities. Some are fortunate not to need a fish, or already got their fish..... Most of us here are forced to fish like maniacs---we don't get to choose when we fish---finding the fish is the key. We will look at what other fisherman do and if successful, adopt that tactic.

All the best,


You don't seem to understand what those "p"s mean. Any p above 0.05 means that the difference is attributable to chance and is NOT statistically significant. You can't make a silk purse out of a sow's ear. Now this was in 117 men taking Provenge (and 59 controls) - it is possible that a larger study might detect a significant difference, but the difference is likely to be small if any.

I agree that overall survival would be a better endpoint, but for post-prostatectomy patients, it may take 15 years until there is usable data. Actually, biochemical progression-free survival has been accepted as a reasonable endpoint.

You also don't seem to understand the trial design. All men were on iADT, so progression only occurred during the vacation. PSADT was NOT statistically significantly different during the vacation among those taking Provenge.

You lost me in your fish metaphor.

Exactly, you don't fish, nor do you need to fish. So, why make a fish comment to begin with in replying to me?? I understand the p< .05 is statistically significant. I did understand they had ADT prior to the trial, and that was my point also---What would happen if Provenge were given while on ADT say, or plus Zytiga or Xtandi ? Will this help delay reaching castrate resistance? No one knows, and so, should someone not attempt to get a fish (ie: extend life/ or cure), by doing this and getting Provenge. As regards the PSADT, there were some that were delayed (statistical significance be damned) using Provenge which means there could be a group that benefits.

If there is clear data that is negative, then list it. Otherwise, the trial you listed did nothing more than cloud the water. It does not help the fishing. If I need a fish, I will use the best knowledge I have regarding fishing, but sometimes, you pull out a lure that has some success, and use it.

I know, you are now, truly lost....

What I wrote was: "Sometimes you got to fish when the fish are biting." Perhaps you are not American. In America, it is an aphorism that means that the best time to go after something is when the thing you are going after is available. it was not meant as a personal affront.

It seems that you're saying that even this trial was not early enough, that if ONLY they had gotten the Provenge 3-4 months earlier, before they even started ADT, that it could have been helpful? Really? 3-4 months? I can't disprove that, but there's no reason to suppose that's true.

It is possible there is a subgroup that could benefit, but they remain unidentified so far.

If you choose to ignore statistical significance, you are in no-man's-land. That, and the fact that you disliked the study, should also alert you to your confirmation bias.

I am an American, and comprehend English. Here was my point (see where the following is in my last post: (and that was my point also---)

What would happen if Provenge were given while on ADT say, or plus Zytiga or Xtandi ? Will this help delay reaching castrate resistance? No one knows, and so, should someone not attempt to get a fish (ie: extend life/ or cure), by doing this and getting Provenge.

I asked you to do the following:

If there is clear data that is negative, then list it. Otherwise, the trial you listed did nothing more than cloud the water. It does not help the fishing. If I need a fish, I will use the best knowledge I have regarding fishing, but sometimes, you pull out a lure that has some success, and use it.

The metaphor of a fish(extending life/or a cure) is lost on you...or of fishing ( searching/trying to extend your life/get a cure) is lost on you as well....The lure would be Provenge. Do you need a fish, Allen? As I understand, you got your fish--great for you....

This is simple....if you have knowledge of a trial where Gusgold can get Provenge and continue his Xtandi, then great. Please provide it. If you know where he can get assistance on this issue then great. Please provide it.The fact that there is not enough data to prove it will work magnificently is not important to a starving man that needs a fish. He is attempting to find a way to extend his life...The fact that there is no negative data should suffice. After all, it is his hand to play, not ours. We are here to help each other. Should we not respect his request unless there is clear negative data?

Should we all wait for the data, and only do those things that we know are clearly positive, safe, and beneficial? If so, then how does one justify participation in clinical trials? I have participated in 1 clinical trial and looking at others. I would rather be in the game, than wait on the sidelines. When one participates in clinical trials, the knowledge benefits many, and possibly yourself also. Perhaps, Gusgold has the same feeling and would rather fight, than wait...If so, respect his decision/ courage and assist him. I have looked and can't provide help. You have him, and if you can help him, then you will have my thanks as well as his....


Fantastic reply, Fish. Very well put indeed. Even though I am an Indian [not red, just brown :-) ] I can understand you perfectly. Touche !!!

This has got to be one of the best posts that I have EVER read (and, I frankly admit, I have not read all) on this board, imho.

Thank you very much, Fish.

Yes, we should all wait for the data, and only do those things that we know are clearly positive, safe, and beneficial, or join a clinical trial where we are carefully observed. People die in clinical trials, so people (like me) who do them are carefully informed of the risks they are taking to benefit others. And because Phase 3 trials are randomized there is no assurance of getting the treatment.

"Cloud the water" apparently means the results do not conform to your preconceived notions. "The fact that there is no negative data should suffice." - So, for example, because there is no data that disproves that cyanide in small amounts kills cancers, that everyone is well-advised to run out and take it? There are lethal risks (autoimmune cascade) associated with Provenge and the cost is $150,000 for 3 doses, so everyone should look for clear data proving safety and efficacy before taking it. The fact is, we have data that shows: no benefit for men with HSPC - why would anyone risk it? This is moot because there is no way that insurance will pay for it until he is detectably metastatic and castration resistant.

Why on earth would Provenge have any effect on castration resistance? The immune system has no effect on castration resistance that I know of - but perhaps you know of some study that suggests that? You can't just make up biology and pretend that it's true. Certainly, we know that it did not reverse castration resistance in men taking ADT.

I do think that Provenge might be particularly useful when used with chemo or radiation.

You compare cyanide to Provenge in prostate cancer? Preconceived notions indeed...That seems like comparing apples and point was whether Provenge with ADT and Xtandi might....see the word...delay castration resistance. Did I say reverse? Asked you to provide negative data if you had it...nothing from you... I asked if you had knowledge of where Gus might get Provenge since he has an interest to be treated and there is no negative data. (None that you can provide).Clearly, you have no interest in helping out.

But hey, you got your fish....go look at some data...

I forgot to mention the Doc said average overall survival was 15 years with no treatment and 15 years with treatment...the reason being treatment eventually makes the cancer more aggressive so no survival example Xtandi and the other AR blockers can cause neuro-endocrine PCa…...of course the DOC could be FOS (full of shit). Also said my PCa is indolent and will take 15 years to kill me with no treatment...69 + 15 = 84 years old...I just threw away my Xtandi...looks like when the PCa gets me Trump will just be leaving office and it will be 13 years since Nalakrats was killed by a Gator

NPfisherman profile image
NPfisherman in reply to gusgold

Glad to hear that timeline for you, Gus....I am betting Nalakrats succeeds....please post the youtube video of you doing the phlebotomy on the gator for the blood....perhaps, you should ask him for a smaller of luck to you....


I posted over a year ago warning people about the Cleveland Clinic and Dr Smuck. He is an arrogant fool who hates any out of the box thinking. Please, please, please, do not go to the Cleveland Clinic.

Weird... Dr. Smuck must have relatives....I've met a few of them.

BTW I never liked Cleveland since they stole my Corvette from the May company parking lot. Thank goodness I got it back the next day, only to be stolen in New York City and never to be seen again....

Good Luck, Good Health and Good Humor.

j-o-h-n Wednesday 01/09/2019 5:26 PM EST

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