AMA Spokesman: 50% of PC Treatments Unnecessary

Contentious discussion...

One reason I didn't have annual screening for four (possibly critical) years was a combination of having early (age 45) high PSAs with 3 negative biopsies, and a lot of noise in the last few years saying PSA screening isn't useful and people just get over treated as a result. Easy for me to put off testing.

So.... in April based on a high PSA again, I suddenly get diagnosed with high risk, G9, PNI, 80% involved, ECE+ indicated. What the hey? The *only* reason this was detected was a PSA test. I have no symptoms otherwise. With this mess, it's rather clear that without treatment my horizon may not be that far away. The bigger question I guess is even with the best treatment plan, how much will we push back that horizon? I know the array of SEs I'm facing are rather unpleasant, and I'm hoping most don't materialize. Sudden existence failure is also a bad SE of PCa.

My urologist, prominent in AUA by the way, said, "You're the kind of guy we're hoping to find by PSA screening, though a year earlier would have been better." So, I'm a little puzzled about the whole proposal to reduce or eliminate screening.

I still think PSA screening is valuable. The key is better interpretation, risk assessment, and serious consideration of who needs to be treated. We need a better freakin' test....

Ziggy - I suppose you're talking about the G6 folks. They were probably told by their urologists that they needed treatment or that treatment was an option. They all have individual circumstances such as age, other health issues, family history etc. Also, many might have had the option of AS and simply didn't liek the option. I don't think it's a black and white picture. Each has to be taken individually.

The new guidelines are no doubt harsh on young guys. That's why a lot of prominent urologists are coming out and expressing their concerns vis-a-vis recommendations for that particular group.

I think most people who have treated PCa don't regret their medical decisions. I know that if I had a G6 at 40 I still would have treated. Not an issue in my case since I was a G7, but sitting on low grade cancer and monitoring it actively is not for everyone.

Tall Allen,
Two questions about the numbers from the PIVOT study:
1) The difference in mortality between the treated and untreated cohorts you state as 2.6% of the total. But couldn't the data also be interpreted as showing a 50% increase in untreated mortality over treated mortality? (31 untreated died vs. 21 treated died out of approximately the same number of patients.)
2) Did it really show that only 17% of men presenting with PC symptoms (pre-PSA era) died from it over the next 30 years? Even for an older cohort, that seems like a very low mortality for these far advanced cases. And do we know if these men had any treatments?
Thanks.

Allen,
I also await for the ProtecT study to shed some clarity on the issue. Your math is correct, but mine is also correct and that was the point of the previous post. Dr. Wilt has been present on the prostate cancer research world since I can remember after my own diagnosis and he chose to report the absolute difference in mortality rather than the actual difference in deaths.

After years and years of recruiting for the PIVOT trial they finally went ahead with a very minimal cohort. These men were older and supposed to have at least 10 years of life expectancy but, as many as 48% died within the first 10 years of the study. Now, I understand that after years and years of recruiting Dr. Wilt was limited with the cohort available to him to randomize. If that is the case why is the PIVOT the best study we have? It might be the best because it is the ONLY we have. That doesn't help men these days to make decisions.

If the Department of Transportation is testing the safety of buses and two designs are being tested for structural integrity in a frontal head-on accident what would be the most accurate report that be useful to future passengers?

Both buses have a capacity of 100 passengers. In a head-on accident the results are as follows:
Bus # 1: 21 dummies representing adult humans would have died of severe head trauma.
Bus # 2: 31 dummies representing adult humans would have died of severe head trauma.

Results*:
21/100 = 2.1% for bus #1
31/100 = 3.1% for bus #2
Percentage absolute difference: 3.1 - 2.1 = 1.1%
Percentage death difference: 31 - 21 = 10/31 = 32.3%

Now if you have to make a decision as a passenger, which bus would you use if given this information? The minimal 1.1% absolute difference or the other more realistic number? The point is that Dr.Wilt did not provide a choice in his reporting...

Now to the Johanssen study. You mentioned that that study is the best “to show that PC has a very long natural history and only a small percentage of men who get it are likely to ever die from it. “ OK. But the cohort of men represented in that study had a medium age of 72 years. Is that a good representative study to show the natural history of a disease that has a slow progression character? An interested fact of this study is also the authors conclusions (which BTW you forgot to mention):
“CONCLUSIONS: Although localized PCa most often has an indolent course, local progression and distant metastasis can develop over the long term, even among patients considered low risk at diagnosis.”

If these are the best studies we have to make treatment/no treatment decisions we are in bad shape...and we are!

RalphV
* Many more buses would have to be tested for structural integrity to obtain a more accurate number.

RalphV,

I know it doesn't help younger guys who are diagnosed with PC at all, but the fact is that both incidence and virulence does increase with age at diagnosis. If surgery were a great treatment for PC, it would significantly reduce cause-related deaths in that group. Out to 12 years, it didn't.

It sounds like the statistic that you and Phenom would like to see is the Relative Risk (RR) or Odds Ratio(OR), which is the ratio of probabilities or odds, respectively. That's fine. I like to look at both the absolute risk reduction and the relative risk. You can see the importance of absolute risk when the numbers are small (as they are here). As a hypothetical, if I have a 1% risk of a heart attack if I watch TV, but a 2% risk if I go for a run, it's true that I have doubled my risk of a heart attack by running, but it is really only 1 in a hundred more, and I won't make my decision based on that "doubled" risk. Conversely (using some real numbers), if I have high risk PC, my 5-year probability of a biochemical recurrence is 45% if I have a prostatectomy at Johns Hopkins, but 22% if I have SBRT treatment. Looking at the Relative Risk in this case may be decision-altering to me because I cut my risk in half by having SBRT.

I agree with you that we always want better research on which to base our decisions.

It's underpowered for subgroups, but not in total. We'll have to see if it will continue to be as time goes on.

Actuarily expected survival of a normal population can't be used as a critique of the sample because all the men in PIVOT had PC. From the Swedish study we see that the median survival of men diagnosed with PC was about 10 years, so survival length in the PIVOT study seems about right. Men should not be screened out because of other conditions if we want the sample to be representative of the population of men with PC.

RalphV said:
"Yeah, we do need better designed trials but, while we wait, the AUA and USPSTF are using the PLCO, PIVOT and ERSPC trials to create screening/treatment guidelines as means to avoid overdiagnosis/overtreatment..."

This has been a very educational discussion for me. But I think it's unfortunate to lump the AUA and the USPSTF together like this in this discussion as the AUA has traditionally been on the side of screening and their new guidelines do to defer from that, and the USPSTF is NOT for any form of screening ever in a mans life. These are drastically differing positions.

I think it will be very important moving forward for the advocacy's to clearly identify that difference. The AUA is taking heat today not because they eliminated screening. But rather because the took a bold step to try to balance the scales of saving that "1 in 1000" versus rampant overdiagnosis and overtreatment that has led to the USPSTF defining that it isn't possible.

I just don't think the AUA should be thrown in front of that proverbial USPSTF bus. Education will be the key to continuing screening with the PSA test. And I think that if that education does not include the emphasis on what overdiagnosis is, and what overtreatment is, and how prevalent it is, then we will again miss the mark.

Tony

davidg said...
Ziggy - I suppose you're talking about the G6 folks. They were probably told by their urologists that they needed treatment or that treatment was an option. They all have individual circumstances such as age, other health issues, family history etc. Also, many might have had the option of AS and simply didn't liek the option. I don't think it's a black and white picture. Each has to be taken individually.

The new guidelines are no doubt harsh on young guys. That's why a lot of prominent urologists are coming out and expressing their concerns vis-a-vis recommendations for that particular group.

I think most people who have treated PCa don't regret their medical decisions. I know that if I had a G6 at 40 I still would have treated. Not an issue in my case since I was a G7, but sitting on low grade cancer and monitoring it actively is not for everyone.

I've been on record for awhile now without any clear opinions for those dx in their 40s. I don't say for sure it's the automatic death sentence in the long run that you do, yes even those with g-7. That grade is a mixed bag even for those in their 50s on up. More study is needed for your age group I'll agree. But numerically it's only a small percentage of the PCa population. It's maybe over represented here because many older coots are computer and internet incompetent. I may be an old fart but my job in the army 40+ years ago was running computers. The Univacs and NCR 500s--- old dinosaurs.

I would say many of those who have radical treatments do have moments of doubt but it's human nature not to regret such past decisions and try not to believe you underwent it and the side effects for nothing. Yes dry orgasms are a side effect that effects all who've had radical surgery even though in comparison to permanent incontinence it pales. It's still an effect.

Personally I don't see the big distinction between monitoring on AS to checking PSA after radical treatments. How is one more dreaded than the other? How is AS not better than undergoing radical treatments and their after effects? If nothing else men can sometimes add additional years of normal life if they have to be treated later, and in many cases not treated at all. And if they do as John T has shown there's no difference as to their PCa outcome in the vast majority of cases. Nothing about PCa is risk free or guaranteed. Also the longer one waits the newer treatments and drugs appear on the scene. As one of the few here with an actual 21st century treatment I can attest to it being far superior as to all the old fashioned last century treatments most have undergone. It's only for lower risk Pca but up to g8 have tried it I know. If i was diagnosed today I 'd do AS without a moments hesitation. Back in 2007 that was considered suicidal here, many here even thought brachytherapy was risky instead of that old 1990s gold standard of radical surgery. I agree that PCa is a number of different cancers a few very aggressive but most not or in the intermediate range. BTW I know of two G7 cases who were successfully treated by TFT too like I have. My treatment was over 5 years ago now, I have no big regrets being it was so minimally invasive and the fact I helped bring along a much better PCa treatment in clinical trial. My only side effect is maybe a 60% loss of ejaculant. And yes I notice it and yes it is less messy but it's still a side effect and yes I miss the 60%. But compared to what others have to put up with post treatment I shouldn't even mention it other that to say even my advanced TFT has an effect. It possibly screwed up my putting today too for it sucked!!! Nah that was just me.

I am, indeed, thinking these days that I may have made some serious mistakes, but to be fair it's taken a year and a half of constant exposure to all the information on HW to begin to realize that. I didn't ask for a PSA test--it was part of my introductory physical for Kaiser when I joined their Medicare plan. With what I know now, I would question the doc about whether that was really necessary or even advisable, and who knows if I would have ever known I had PC, but instead could have just lived my life out normally? Then, when diagnosed, all the emphasis was on surgery. The way all the uros talked about it, the other treatments were, though acceptable, not the "Gold Standard," as they actually called it. I looked into all of them, was ruled ineligible for brachy, liked the surgeon I met with, didn't like the radiologist or her facility, and figured that surgery was the quick and mechanical way to go--no nuclear zapping, no 40 trips for treatment, and especially no two years of Lupron (that really swayed me when I looked into that stuff.) A day in the hospital, several more recovering at home, and that would be it, I would be "cured." As for side effects, the information on those was all over the map and it seemed very individual as to how each man came through. Like most men, I figured I'd deal with whatever they were. Now, two years after diagnosis, I'm questioning all of it. And with a possible recurrence under way, radiation could be in the cards anyway. As Ziggy says, why not just do that to begin with--what was all that about a "second shot at a cure" after surgery but not after radiation, anyway? It's beginning to get pretty depressing, all in all. I feel like my experience took place in the dark ages, so to speak, and the enlightenment is just beginning. At least that is something to celebrate.

Tony,
Both organizations did the research of the medical literature and reviewed those studies. The USPSTF recommendations are an extreme. Their recommendation is for the GP gatekeepers who are regularly the first ones to Rx(or not) a PSA test. I was not linking those two organizations just that they used the same literature to come up with their guidelines. Now the AUA is trying to fix their image. Bad, greedy urologists treating all those men unnecessarily. Have you asked yourself why so many localized therapies fail? It is not only surgeries that fail...

Please do not tell me that the AUA is saving that “1 in a 1000" with their guidelines to balance the scales. Show me a real-life study in which the overdiagnosis and overtreatment is anyway near what the computer models calculate. It is all based on lead-time estimates. Some 50% of the population at risk has never had a PSA test in their lives and now these guidelines are going after the 50% that does (somehow irregularly and with much confusion). Why aren’t we more preoccupied about those 30,000 men that continue to die from PCa every year? What is going on with those? Surely they were not overdiagnosed or overtreated...

True, men fail to understand they need to be educated about their health. They need to have more self-interest in their health care to prevent being snowed under.

One big fallacy of the guidelines is that men should talk to their doctors about the pros and cons of the PSA test. That is called informed consent and I have not seen an unbiased form or protocol that can be called informative for men to decide either way...go ahead and depend on your doctor’s opinion to decide for you...

RalphV

davidg said...
my wife is a HUGE fan of dry orgasms. I don't mind them. No regrets here.

I see a huge distinctions between proper responsible AS protocols and mere PSA test post treatment. I mean a huge difference from my personal perspective. 7.15 PM and still in the office so I won't get into it now.

I didn't say you should mind dry orgasms, but you should acknowledge you aren't effect free as you keep posting. Just to keep it real for the new guys. All treatments have effects. Most minor, a few tragically life altering.

Honestly I see after surgery testing to be much scarier than AS testing. I'm sure others can attest to the fear you kept posting looking forward to your test I remember it well. Even after being treated by super doc you were understandably scared I understand why for if it fails you go to SRT with only a 30% success rate, because it's likely systemic. Now compare that to someone on AS who only has to possibly choose his first initial treatment at worse. Face it once we have been DX with PCa we all have a life time of tests ahead of us. Although after 5 years my doctor has told me last February whatever I die of it won't be PCa. But still I'll go in for annual testing.