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More Evidence Supporting AS for Low Risk PCa

Kongo's picture
Kongo
Posts: 1167
Joined: Mar 2010

This paper was published in Urology Today at www.urotoday.com. As other recent posts have suggested, it offers strong support of active surviellance as a viable treatment course for low risk prostate cancer in men. I found it interesting that 30 percent of the men in this study had urinary issues and that nearly 50% reported some degree of sexual dysfunction.

This is interesting to me because we frequently find ourselves quoting statistics about incontinence and ED associated with various treatment options. What none of these statistics seem to take in account is that there is a fairly high percentage of men in the age ranges where prostate cancer is prevelant who have incontinence and ED issues even BEFORE treatment.

This study also suggests that there is little danger in waiting to treat the disease and that in most cases there is never any progression that warrants treatment.

===========================================
Wednesday, 15 September 2010
Department of Urology, Miller School of Medicine, University of Miami, Miami, Florida, USA.

With the advent of prostate-specific antigen (PSA) screening and the increase in the number of transrectal ultrasound-guided biopsy cores, there has been a dramatic rise in the incidence of low-risk prostate cancer (LRPC). Because > 97% of men with LRPC are likely to die of something other than prostate cancer, it is critical that patients give thought to whether early curative treatment is the only option at diagnosis.

To identify a group of men with LRPC who may not require initial treatment and monitor them on our active surveillance (AS) protocol, to determine the percentage treated and the outcome and to analyze the quality-of-life data.

We defined patients eligible for AS as Gleason < /=6, PSA < /=10, and two or fewer biopsy cores with < /=20% tumor in each core.

Kaplan Meier analysis was used to predict the 5-year treatment free survival. Logistic regression determined the predictors of treatment. Data on sexual function, continence, and outcome were obtained and analyzed.

The AS cohort consisted of 230 patients with a mean age of 63.4 yr; 86% remained on AS for a mean follow-up of 44 mo. Thirty-two of the 230 patients (14%) were treated for a mean follow-up of 33 mo. Twelve had a total prostatectomy (TP). The pathologic stage of these patients was similar to initially treated TP patients with LRPC. Fourteen underwent radiation therapy, and six underwent androgen-deprivation therapy. Fifty percent of patients had no tumor on the first rebiopsy, and only 5% of these patients were subsequently treated. PSA doubling time and clinical stage were not predictors of treatment. No patient progressed after treatment. Among the AS patients, 30% had incontinence, yet < 15% were bothered by it. As measured by the Sexual Health Inventory for Men, 49% of patients had, at a minimum, moderate (< /=16) erectile dysfunction.

If guidelines for AS are narrowly defined to include only patients with Gleason 6, tumor volume < /=20% in one or two biopsy cores, and PSA levels < /=10, few patients are likely to require treatment. Progression-free survival of those treated is likely to be equivalent to patients with similar clinical findings treated at diagnosis.

Written by:
Soloway MS, Soloway CT, Eldefrawy A, Acosta K, Kava B, Manoharan M.
Reference: Eur Urol. 2010 Aug 20. Epub ahead of print.
doi: 10.1016/j.eururo.2010.08.027

PubMed Abstract
PMID: 20800964

hopeful and opt...
Posts: 2226
Joined: Apr 2009

This study pretty much targets my situation, low risk prostate cancer enrolled in an active surveillance program........I especially like the part that reads,

"If guidelines for AS are narrowly defined to include only patients with Gleason 6, tumor volume < /=20% in one or two biopsy cores, and PSA levels < /=10, few patients are likely to require treatment. Progression-free survival of those treated is likely to be equivalent to patients with similar clinical findings treated at diagnosis"

I've made a copy of this information.

Ira

steckley
Posts: 100
Joined: Aug 2009

Kongo,

I have few problems with these numbers...but I'll only wax on three.

The first problem I have is with the statements.... " > 97% of men with LRPC are likely to die of something other than prostate cancer". This tends to imply that PC is not a problem ... only 3% of those diagnosed will die of the disease.

However, if you divide the number of US men who will die of PC in 2010 (32,000) by the number who will be diagnosed with PC (218,000) you come to a much different conclusion .... that about 15% of the men diagnosed with PCa will die of PCa.

The arguement can be made that the 3% is for LRPC PCa ... which leads to my second problem. Based on what I have read, there are not readily available good methods to screen for LRPC. Biopsies are understated ... Gleeson scores are commonly upgraded after prostates are removed ... remote scanning devices (MRI and Doppler) can not detect small tumors ... etc.

My third problem is that the study only appears to have lasted 44 months and included only 230 patients ... guess I should get the rest of the study and not rely on the abstract, but I feel it is likely that 44 months and 230 patients does not yield a good population to draw any statistically valid long term conclusions.

Oh well ... for other reasons, I think AS may be good for a lot of guys. I just don't think this study makes the case.

hopeful and opt...
Posts: 2226
Joined: Apr 2009

LRPC are the first letters of " low risk prostate cancer", so these leters stand for this sub set of those with prostate cancer, not the entire of population of those stricken with the disease.

>97 percent is based on a different study not listed in this release; there was one where autopsies were performed in a city which showed many men who died with prostate cancer, not because of it....this may or may not be the study where this information came from...if this is in fact the study all the imperfections in methods that you perceive( below in quotes) are accounted for.

"Based on what I have read, there are not readily available good methods to screen for LRPC. Biopsies are understated ... Gleeson scores are commonly upgraded after prostates are removed ... remote scanning devices (MRI and Doppler) can not detect small tumors ... etc."

The longest running study that I know of was done in Canada( 8 years), which is on my "about me" Simply click my name......Of course I would like to see this and other studies that are underway continued for a greater lengths of time so one can make better decisions in the future.

Ira

mrspjd
Posts: 694
Joined: Apr 2010

Do you know if the AS clinical study at UCLA is still recruiting/enrolling new participants? If so, what are the qualification parameters (asking for an acquaintance who is still considering options). Thanks.

got the email, thanks.

steckley
Posts: 100
Joined: Aug 2009

I am not sure how the autopsy study relates to there not being readily available good methods to screen for LRPC. I feel that the ability to diagnose LRPC is currently somewhat questionable. For example, using the numbers in the study being questioned 14% of the men screened and classified as LRPC went on for further treatment ... Were these 32 men miss-diagnosed as LRPC?

As an aside, I've been reading an interesting thread on the Healing Well forum, where a member contacted Bostwick and John Hopkins to ask what their procedures were for performing Gleesons. Seems Bostwick uses an old protocol and John Hopkins uses a new protocol. The old protocol gave (gives) many more 6's than the new protocol (which gives more 7's). This difference would be important to understand if a person is basing their treatment method on having a Gleeson of less than 7.

Kongo's picture
Kongo
Posts: 1167
Joined: Mar 2010

Steckley,

I think our posts my be crossing in the air and may be difficult for someone followng this thread to see who said what when but in response to your post at 10:33 today I would offer the following.

Although the study did show that 15% came off treatment the abstract doesn't address the reasons why. I have read other studies that indicate that some men come off treatment as a result of a rise in PSA or an abnormal DRE or follow-on biopsy, but that most men exit AS not as a result of any physical manifestation, it's just that they decide to pursue treatment. I don't know whether it's a result of ongoing anxiety about waiting for a surprise at the next office visit or that they finally gathered enough information that they felt seeking treatment was a better course for them. I think a patient on AS is probably more informed about PCa and ongoing advances than most others who seek treatment and go on with their lives.

The comments about the Gleason grading systems is interesting. As you raised in your first response to my initial post, many Gleason scores are upgraded following a post RP biopsy. Although I don't buy the argument that an advantage of RP is that you "know for sure" what is in your prostate, I have trouble understanding the true meaning of what that upgraded score really means. Many would say it indicates that initial biopsies do not accurately assess the true state of the cancer but it seems to me that regardless of the stage, as long as it remains contained within the prostate it is not going to kill you. Of course, we all suspect that a higher Gleason grade corresponds to a more aggressive cancer tht will eventually break of the prostate but when you look at the long term survival statistics between AS, RP, and radiation, there just isn't that much difference. Since AS and radiaton patients don't have their prostates removed we don't know for sure, but we would presume that if they did have them removed that their Gleason scores would be upgreaded at roughly the same rate as those who have RP. So what does the frequency of upgraded Gleason scores afer RP really mean? I don't know but I suspect that the Gleason may not be as strong an indicator in determining long term prognosis as many of us think and that it is just one of several factors that have to be taken into consideration.

Regarding your comment about differing methodologies between Bostwick and Johns Hopkins, my first reaction is like, WTF???!!! You would think these two prestigious centers could agree on a protocol that allows us to compare apples to apples and prostates to prostates without wondering what procedure they're following.

steckley
Posts: 100
Joined: Aug 2009

Sorry about the crossing posts; I'm getting online for work and other stuff in between honey-does ...

Thanks to you and Ira for all of your input; however, I am still left with the question of whether readily available screening can adequately diagnose LRPC. Based on what I've seen Gleeson's alone can not ... and the resolution of scanning devices (MRI and color doppler) are not fine enough to detect small tumors. Ira has explained to me that there are other methods being developed, and my guess is that in the future there will be good screening techniques available for LRPC.

hopeful and opt...
Posts: 2226
Joined: Apr 2009

In 2005 the results of an 8 year study about LRPC was published in Canada...the tools available then were less than now since the study was designed and started 14 years ago, howver, this study posted below show how effective the diagnosis was at that time. Now with better tools available, diagnosis and monitoring of LRPC will be enhanced.......Ira

Here are some results of Lawernce Klotz,MD, well respected

active sureilance expert

protocol:

PSA and DRE every 3 months
Prostate ultrasound every 12 months
Repeat biopsy at month 12 and 36

After 8 years:

- 55% remain untreated with stable disease

- 36% decided to have treatment(eventhough they did not have progression)

- 9% treated with surgery or radiation for increase in psa or gleason score

- none have metastatic disease
< 1% men died of prostate cancer

---------------------------------------------------
Analysis of Bill Axelson by Lawernce Klotz, MD
Journal of clinical Onchology 2005

. lower gleason
. less than 1/3 cores and none >50%
. PSA < 10 and not rising
. PSA density < 0.15
. no palpable diesease
. early treatment for any progression

FOR LOW RISK, 100 SURGERIES WILL SAVE 1 LIFE 10 YEARS IN THE FUTURE

Kongo's picture
Kongo
Posts: 1167
Joined: Mar 2010

Steckley,

Your raise many excellent points which I believe underscore the urgent need for more definitive research in this area. While there are other studies that report similar statistics with larger cohorts over extended periods of time (I believe Ira referenced one) we still cannot say with assured certainty whether or not AS is the best course of treatment for men with low risk prostate cancer, although the evidence suggests that following this course with frequent follow-ups and close observation is unlikely to cause harm or negatively impact later treatment options should they become necessary.

An underlying agenda to this study and others that suggest a high degree of overtreatment of prostate cancer in the United States is the soaring cost of health care. I recently read that last year we spent $3B in the United States on PSA testing alone. If you look at the costs of all the other treatments performed each year, the combined cost of treating just this single disease is truly staggering. Of course, I realize it is easy to say we have to lower health care costs before it bankrupts us, but when cancer happens to us as individuals we all want the best possible treatment and the best facility and we don’t care about cost. I want my sons and grandsons to have access to the same level and quality of care I have received and if AS can help us to safely move in that direction by helping to reduce costs, I’m all for it. I do agree that we need more research to enable us to better predict which men can safely pursue AS as a primary treatment course. This study suggests that grouping PSA, Gleason, and biopsy results is one way to identify potential AS candidates but I am sure we can develop a more definitive method to hone this analysis.

One aspect of the study that did give me pause, and I noted it in my original post, was the rather surprising (at least to me) amount of men in this study who had pre-existing incontinence and ED issues at a median age of 63.4 years. It made me reconsider earlier positions I have taken about side effects of certain treatments, such as RP for example, which generally pose higher risk of incontinence and ED than newer forms of radiation. Few of the treatments that boast long term incontinence and ED statistics seem to take into account pre-existing conditions or look at the roles body mass, age, overall health, diet, lifestyle, and so forth have on long term quality of life after treatment. It seems to me that if you have issues passing urine or maintaining potency before any treatment for whatever reason, you are going to have issues following treatment.

In my own case, my initial diagnosis put me squarely in the center of what the study defined as low risk prostate cancer. I looked at AS very closely at the time of my diagnosis and now, with the benefit of hindsight and even more understanding of PCa, I think I would have done fine following that course. For a number of reasons I chose treatment and although I frequently second guess myself, I have no regrets.

===================================
Age at Dx: 59. PSA at Dx: 4.3 which later dropped to 2.8 after eliminating dairy. Gleason 3+3=6. 1 of 12 biopsy cores positive with 15% involvement. DRE normal. No physical symptoms or history of PCa in family. Stage T1c.

Treatment: SBRT via CyberKnife in June 2010. Side effects: None to date.

steckley
Posts: 100
Joined: Aug 2009

I hear you on the second guessing ... the longer I am away from my treatment, and the more I study, the more I second guess. It seems that I was so much wiser then (pre-op) ... I'm dumber than that now.

Swingshiftworker
Posts: 1013
Joined: Mar 2010

I briefly considered AS when I was researching the available treatment alternatives.

My decision "matrix" put AS high on the list when compared only w/surgery given the extreme risks associated w/the surgical removal of the prostate. However, given less draconian treatments, like BT, CK and PBT, AS seemed a less necessary option. FWIW, I would have chosen surgery ONLY if I had a later stage or more aggressive PCa, where no other option was available.

The common justification for going w/AS is that the 5 yr survival rate with or w/o treatment in early stage PCa patients is about the same, but IMHO some treatment is better than none, AS LONG AS the consequences of the treatment are not significantly worse than simply doing nothing.

In this case, CK and PBT trumped BT, which has a record of greater potential urinary and associated tissue damage than CK and PBT and also requires the placement of radioactive metal seeds in your prostate which stay radioactive for about a year (which presents some risk for babies, young children and pregnant women) and (except for those seeds that wander and get peed out) stay in your body forever and require you to get a special ID to board airplanes.

So, the only remaining choice for me was either CK or PBT. CK won because I could get it at UCSF in SF where I live (instead of having to move to Loma Linda in Socal for 2 months to get PBT); it was paid for by Blue Shield CA (never got any verification that insurance was available for PBT); and required 4 treatments (instead of 40-45 treatments for PBT).

Obviously, everyone's choices are determined by their individual circumstances and means. This was just what led me to the choices that I made. Here's wishing each of you the BEST outcome, based on the choices you make!

steckley
Posts: 100
Joined: Aug 2009

Kongo

I was reading a post on another forum which made me think of your 50% ED question on this thread. Not that I have an answer to why 50% of the men in this study had some form of ED going into the study, but ....

Anyhow, the post I am refering to cited a surgeons claim of 64% of his RP patients not having ED after the RP. If I combine this surgeons statisticts with the your studies 50% of men having ED going into the study I conclude that the surgeon is actually curing some guys of ED when he performs RP .... I feel the need for a grain of salt. Back to work.

Kongo's picture
Kongo
Posts: 1167
Joined: Mar 2010

Steckley,

I too was pretty gobsmacked by the 50% (actually 49%) ED statistic cited in the study and although the abstract lumped even mild forms of ED together under this category, it still seemed high to me. But like politics, all sex is personal, so who knows for sure? I think the source of confusion arises from how ED is defined and there are a couple of different surveys that are in use which give significantly different data depending upon how questions are posed and who asks.

Plus, as men, we all know that we are likely to understate (or outright lie) about this condition. I have read a couple of studies that asked both men and their spouses about ED and they came up with significantly different statistics. Not surprisingly, the survey commpleted by spouses indicated a higher degree of dysfunction (in all forms) than what the men said. What a newsflash! LOL

Many doctors use the loosest definition of potency when quoting post procedure statistics which is something like the ability to achieve an erection sufficient enough to achieve penetration at least once a month. To me, that definition is like, huh, you have to be kidding.

In any event, we will never know the real numbers as nobody is going to follow us around in the bedroom taking notes and making observations.

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