New research on pre-treatment PSAV

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proscapt
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   Posted 12/15/2010 8:00 PM (GMT -6)   
Some of us can relax a bit, others not so much...

free pdf available at www.springerlink.com/content/15t0rv0q0643862w/fulltext.pdf

World J Urol. 2010 Dec 14. [Epub ahead of print]
Significance of preoperative PSA velocity in men with low serum PSA and normal DRE.

Makarov DV, Loeb S, Magheli A, Zhao K, Humphreys E, Gonzalgo ML, Partin AW, Han M.

Department of Urology and The Section on Value and Comparative Effectiveness, New York University School of Medicine, New York, NY, USA.
Abstract

OBJECTIVES: A PSA velocity (PSAV) >0.35 ng/ml/year approximately 10-15 years prior to diagnosis is associated with a greater risk of lethal prostate cancer. Some have recommended that a PSAV >0.35 ng/ml/year should prompt a prostate biopsy in men with a low serum PSA (<4 ng/ml) and benign DRE. However, less is known about the utility of this PSAV cutpoint for the prediction of treatment outcomes among men undergoing radical prostatectomy (RP).

METHODS: Between 1992 and 2007, 339 men underwent RP at our institution with a preoperative PSA <4 ng/ml, benign DRE, and multiple preoperative PSA measurements. PSAV was calculated by linear regression analysis using all PSA values within 18 months prior to diagnosis. Kaplan-Meier survival analysis was performed, and biochemical progression rates were compared between PSAV strata using the log-rank test.

RESULTS: The preoperative PSAV was >0.35 ng/ml/year in 124 (36.6%) of 339 men. Although there were no significant differences in clinico-pathological characteristics based upon PSAV, men with a PSAV >0.35 ng/ml/year were significantly more likely to experience biochemical progression after RP at a median follow-up of 4 years (P = 0.022).

CONCLUSIONS: In this low-risk population with a preoperative PSA <4 ng/ml and benign DRE, approximately 1/3 had a preoperative PSAV >0.35 ng/ml/year. Physicians should carefully monitor men with a preoperative PSA >0.35 ng/ml/year as they are at increased risk of biochemical progression following RP.

...don't panic. even among those in the high PSAV group, the percentage who had biochemical failure (recurrence) was still only 4% in 4 years. That's statistically higher than the other group, but still low overall...


The good news [for some] is that among those with preop PSA<4, DRE negative, and PSAV < 0.35, the number who experienced biochemical progression over 4 years was ZERO! I wish I were one of those.

Jerry L.
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   Posted 12/15/2010 8:58 PM (GMT -6)   
"A PSA velocity (PSAV) >0.35 ng/ml/year approximately 10-15 years prior to diagnosis is associated with a greater risk of lethal prostate cancer."

Let's see --- that would put me at age 29-34...I doubt I have those PSA results...
Nov. 2009 Dx at Age 44
Dec. 2009 DaVinci Robotic Surgery
Jan. 2010 T3b, Gleason 9
Feb. 2010 Adjuvant Radiation

PSA History:
-----------------
Nov. 2009 4.30
Feb. 2010 <.05
May 2010 <.05
Aug. 2010 <.05
Nov. 2010 <.05

proscapt
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   Posted 12/16/2010 1:40 AM (GMT -6)   
Just to clarify, what the researchers did was take a group of people who had prostatectomy and who also had signs of relatively mild disease just prior to the RP. All had PSA < 4 and nothing that could be felt by DRE. Then the researchers checked which of this population had low psav (low being defined as less than 0.35 ng/ml/year) and which had high PSAV. As you would expect, this population was almost all gleason 6, only about 10% were gleason 7 or higher. about one third had high PSAV (>.35 ng/ml/year.) Of those with low PSA, NONE had a recurrance in the study period (about 4 years) Of those with high PSAV, 4% had a recurrance in 4 years.
DX at age 54 12/2009
Initial clinical profile: PSA 5.6, DRE-, high pre-op PSAV. Clinical stage T1c
Biopsy: Gleason 3+4 with PNI / 6 of 14 cores + / 10% of total length + / worst 45% +
TX: Robotic assisted RP 2/2010
Pathology: pT2cNx / Gleason 3+4 / PNI+ / SM- / SV- / EPE- / Tumor vol 7% / vol 40cc / 63 Grams
PSA - 4/10 <0.01, 8/10 0.01, 12/10 0.01

Jerry L.
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Date Joined Feb 2010
Total Posts : 3072
   Posted 12/16/2010 8:37 AM (GMT -6)   
This is one of those studies where I don't understand why there needs to be a 15 year study. Why can't the leaders in this field create and use a database to store tens of thousands of key patient stats? The sample would be significantly larger and all sorts of info could be learned with a few clicks vs. a lot of years.
Nov. 2009 Dx at Age 44
Dec. 2009 DaVinci Robotic Surgery
Jan. 2010 T3b, Gleason 9
Feb. 2010 Adjuvant Radiation

PSA History:
-----------------
Nov. 2009 4.30
Feb. 2010 <.05
May 2010 <.05
Aug. 2010 <.05
Nov. 2010 <.05

ChrisR
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Total Posts : 831
   Posted 12/16/2010 2:02 PM (GMT -6)   
Hold on.
 
Proscapt,  the "study period" was 1 to 9 years.  Not 4.  The median follow-up was 4 years.
 
If you look at the graph none of the less <.35 PSAV people had recurrence.  Even the ones who were 9 years out from RP.
 
Jerry L,
 
Not sure what you mean by saying "why there needs to be a 15 year study."  J.H. was just saying that some studys have suggested that PSAV 10 to 15 years prior to PCa detection of greater then .35 has been associated with high risk PCa.
 
 

proscapt
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Total Posts : 644
   Posted 12/16/2010 3:55 PM (GMT -6)   
Jerry - often these studies are done just the way you say. They do keep long term records at many institutions, and some of the patient records are shared (after being anonymized) across institutions. So for a study like this, they would go back into the earlier records, and pick patients who were treated long ago, whose cases meet the study criteria. Then they would look and see how those patients turned out. So the whole study might just take a few months to complete, even though the study might cover a period of decades or more. The duration of any individual patient's history varies, as Chris R points out: the earliest patients in the sample have 9 years of data, the median patient has 4 years, and the most recent patients have a lot less.

This type of study is called "retrospective." Some studies are "prospective"; they start at a given time, collect data for a number of years, and then report on it. Prospective studies are more reliable in some ways, but they cost more and they obviously take much much longer to conduct. So people will do retrospective studies wherever they can. If the issue in question is something that is brand new (a new drug, new procedure, etc.) or it is about something that people did not think of tracking ten years ago, then obviously a retrospective study is impossible and a prospective study is the only option.

Chris R - I was struck by the fact that the low PSAV group had Zero recurrences even out to the 9 year point, and certainly at the median 4 year point. Now, most of these are gleeson 6's but there were some 7+ in there too.

ChrisR
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Date Joined Apr 2008
Total Posts : 831
   Posted 12/16/2010 4:38 PM (GMT -6)   
Here is what I don't understand.
 
"In the subset with biochemical progression, the mean
preoperative PSA and PSAV were 2.63 ng/ml and 1.00 ng/
ml/year, respectively. Sixty-seven percent had non-organconfined
disease, and all demonstrated Gleason pattern 4 in
the surgical specimen. The median time to failure was
3 years, with a mean postoperative PSA doubling time of
28.7 months."
 
67% had non-organconfined disease, and all of those 67% had Gleason pattern 4.
 
or
 
67% had non-organ confined and all of those who failed in this subset had Gleason pattern 4.
 
Which is it?
 
 

proscapt
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   Posted 12/16/2010 6:11 PM (GMT -6)   
I read it as the latter. 100% of those who failed had pattern 4, not 100% of those who failed and had non-organ confined disease had pattern 4.

Doing a little math, here's what I get. Be careful in what you conclude, the sample size of recurrances is quite small - only 5 people.

124 out of 339 people in the sample had high PSAV (> 0.35)
19 of these had some pattern 4.
5 of the 124 people in the HIgh PSAV group progressed, all of whom had some pattern 4. (4% of the high PSAV group)
That means 14 people with high PSAV had some pattern 4 and yet did not progress.
So, knowing only this, if you fit the population of low psa, non-palpable, high PSAV and some pattern 4 you have 26% chance of progression. Of course, the numbers are very small and probably not significant at this stage.

67% of the progressors had non-organ confined disease (OCD).
That means 3 progressors had non-OCD.
Of all the high PSAV people, 10 had non-OCD.
So seven of the 10 high PSAV people had non-OCD and yet did not progress.
so knowing only this, if you fit the population (low PSA, non palpable, high PSAV, non-OCD) you have a 30% chance of progression and a 70% change of being ok.

Of course, some of the people with non-OCD are also Pattern 4, and we have no way of knowing given the data presented.
It's theoretically possible that if you are high PSAV, pattern 4 but OCD you are ok, and if you are high PSAV, no pattern 4 but not OCD, that you are also ok. The devil may lie in the combination of gleason 4 and non-OCD. But we have no way of knowing that from the data presented.

Does my math hold up?
You could always send an email to the authors asking for more explanation.

If you are interested in more on PSAV you might want to check these articles, which I posted in another earlier thread:


"Among the 852 consecutive patients in our series2 (1989 to 2002; median follow-up, 3.4 years [range, 0.4 to 14.6]) and who met the eligibility criteria of D'Amico et al., a PSA velocity of more than 2.0 ng per milliliter per year was associated with more advanced clinical and pathological stages, but not with recurrence of cancer or a reduction in overall survival. The probability of death from any cause at seven years was 7 percent (95 percent confidence interval, 5 to 9 percent) among those with a PSA velocity of 2.0 ng per milliliter per year or less and 7 percent (95 percent confidence interval, 2 to 13 percent) among those with a PSA velocity of more than 2.0 ng per milliliter per year.” Source: Bianco, Kattan, Scardino in JAMA www.nejm.org/doi/full/10.1056/NEJM200410213511723

Pretreatment Prostate-Specific Antigen (PSA) Velocity and Doubling Time Are Associated With Outcome but Neither
Improves Prediction of Outcome Beyond Pretreatment PSA Alone in Patients Treated With Radical Prostatectomy
Matthew Frank O’Brien, Angel M. Cronin, Paul A. Fearn, Brandon Smith, Jason Stasi, Bertrand Guillonneau,
Peter T. Scardino, James A. Eastham, Andrew J. Vickers, and Hans Lilja


Urology. 2007 May;69(5):931-5. Assessment of prostate-specific antigen doubling time in prediction of prostate cancer on needle biopsy. Spurgeon SE, Mongoue-Tchokote S, Collins L, Priest R, Hsieh YC, Peters LM, Beer TM, Mori M, Garzotto M. which found: "In contrast to its prognostic value after the diagnosis of prostate cancer has been established, PSA kinetics offer little to clinical decision making as predictors of cancer or high-grade cancer in men with a PSA level of 10 ng/mL or less."

Post Edited (proscapt) : 12/16/2010 4:28:50 PM (GMT-7)


Purgatory
Elite Member


Date Joined Oct 2008
Total Posts : 25393
   Posted 12/16/2010 6:45 PM (GMT -6)   
proscapt,

i, for one, appreciate what you posted and the information it contains. even though it may only directly effect a few, i am one of them. my whole pc journey has been about psa velocity, and so far, its acting text book perfect to the theory.

look at some of my psa numbers:

july 2005 3.5
july 2006 4.2
july 2007 5.8
july 2008 12.3
oct 2008 16.3

these are all pre-primary treatment of course. factor in too, no postive dre's ever, no infection ever - not even a passing uti, no urination problems, hard stream, no getting up at night, no ED issues, no family prostate cancer history (at least known)

diagnosed as gleason 7 (4+3), no original staging
had open surgery, pathology showed gleason 7 (3+4) t2c, 1 small positive margin

had confirmed BCR within 9 months of surgery despite pathology

then had SRT, 39 sessions, prostate bed, 72 gys

first 2 post SRT psa readings went down, 3rd went up, current status unknown (by choice) until 2/11

both urologist and radiation oncologist felt that with my psa velocity issues, that any psa of .05 after primary or secondary treatment indicated a return of the PC.

this point has been argued before by others, but my doctors and i feel that pre-treatment extreme psa velocity trumps actual Gleason post-treatment. so far, my journey is heading that direction. don't have the full proof yet, another psa reading or two, but expecting SRT to fail, as radiation doctor only gave it a 20% chance of working in the first place.

thats why i am so pragmatic about the whole thing sometimes.

david in sc
Age: 58, 56 dx, PSA: 7/07 5.8, 10/08 16.3
3rd Biopsy: 9/08 7 of 7 Positive, 40-90%, Gleason 4+3
open RP: 11/08, on catheters for 101 days
Path Rpt: Gleason 3+4, pT2c, 42g, 20% cancer, 1 pos marg
Incont & ED: None
Post Surgery PSA: 2/09 .05,5/09 .1, 6/09 .11. 8/09 .16
Post SRT PSA: 1/10 .12, 4/8 .04, 8/6 .06 11/10 Not taking it
Latest: 6 Corr Surgeries to Bladder Neck, SP Catheter since 10/1/9, SRT 39 Sess/72 gy ended 11/09, 21 Catheters, Ileal Conduit Surgery 9/23/10

Jerry L.
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Date Joined Feb 2010
Total Posts : 3072
   Posted 12/16/2010 6:53 PM (GMT -6)   
Proscapt,
 
Thanks for all the info...
 

Purgatory
Elite Member


Date Joined Oct 2008
Total Posts : 25393
   Posted 12/16/2010 7:53 PM (GMT -6)   
p.s. meant to show the jumps in psa per year, if they think >.35 is serious, then what do you make of:

year 2006, had jumped .7 from prior year
year 2007, had jumped 1.6 from prior year
year 2008, had jumped 6.5 from prior year
then in just 3 more months, jumped 4.0, that was a jump of more than 1.0 per month during that period
Age: 58, 56 dx, PSA: 7/07 5.8, 10/08 16.3
3rd Biopsy: 9/08 7 of 7 Positive, 40-90%, Gleason 4+3
open RP: 11/08, on catheters for 101 days
Path Rpt: Gleason 3+4, pT2c, 42g, 20% cancer, 1 pos marg
Incont & ED: None
Post Surgery PSA: 2/09 .05,5/09 .1, 6/09 .11. 8/09 .16
Post SRT PSA: 1/10 .12, 4/8 .04, 8/6 .06 11/10 Not taking it
Latest: 6 Corr Surgeries to Bladder Neck, SP Catheter since 10/1/9, SRT 39 Sess/72 gy ended 11/09, 21 Catheters, Ileal Conduit Surgery 9/23/10

proscapt
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Date Joined Aug 2010
Total Posts : 644
   Posted 12/16/2010 8:33 PM (GMT -6)   
David in SC

My situation is somewhat similar to the early part of your trajectory, though so far, no recurrence.

PSA's prior to diagnosis
1.7 fall 2006
2.0 fall 2007
2.6 fall 2008
3.6 fall 2009
(note... a pretty consistent 35% per year increase)

when it went to 2.6 I asked my GP if I needed to see a uro, and he said basically no one goes to see a uro with a PSA of 2.6 unless DRE+

So then when it hit 3.6 I saw the uro, had the biopsy, 14 cores, 6 positive, G3+4. Scheduled for surgery. The week before surgery I wanted to get a retest just to see if all my hard work eating better, pomegranate juice, vitamin D, losing weight, etc. made any difference.

result: after just 4 months, PSA went up to 5.6 - a jump of 2.

path report confirmed g3+4, otherwise clean: EPE-, SM-, SV- They didn't examine lymph nodes.

Now I'm 10 months past RP with PSA's of <.01, .01, .01

Doc said not to do any adjuvant given clean pathology. (I discussed this on an earlier post a couple months ago.) I said to the doc (a highly rated one at a major center, btw) "What does it mean that my PSA spiked so much in the three months before surgery? He said "It means it's good we got it out when we did" and that was that.

So now basically I'm among the "worried clean." For now.

I haven't anything like the challenges you've had ... but anything I see about PSAV I read like a hawk and everyday I think about whether I should be more aggressive.

best,
David

Purgatory
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Date Joined Oct 2008
Total Posts : 25393
   Posted 12/16/2010 8:41 PM (GMT -6)   
david (feels weird writing to my own name, lol)

with all those .01 10 months out, and reading your stats, i would tend to agree with your doctor. your next course of action would be SRT of course, and it would be your last curative hope, if you had recurrance. I would save that card for when there is confirmed BCR in my opinion. your final upward spike is a bit curious, and just like when my jumped from 12.3 to 16.3 in 3 months, it was frightening. i should add, that it took 3 biopsies to spot the cancer, and it was a targeted 3rd biopsy into the shadows the dr. saw on #2. it hit pc in 7 out of 7, ranging from 40% to 90%, so it hit pay dirt. i can only imagine what i would have ended up if i had waited another year for the 3rd biopsy, as was my intention. my uro, a wise experienced dr, talked me out of that move, and might have saved my life, or at least not ending up stage 3 or 4 upon dx.

david in sc
Age: 58, 56 dx, PSA: 7/07 5.8, 10/08 16.3
3rd Biopsy: 9/08 7 of 7 Positive, 40-90%, Gleason 4+3
open RP: 11/08, on catheters for 101 days
Path Rpt: Gleason 3+4, pT2c, 42g, 20% cancer, 1 pos marg
Incont & ED: None
Post Surgery PSA: 2/09 .05,5/09 .1, 6/09 .11. 8/09 .16
Post SRT PSA: 1/10 .12, 4/8 .04, 8/6 .06 11/10 Not taking it
Latest: 6 Corr Surgeries to Bladder Neck, SP Catheter since 10/1/9, SRT 39 Sess/72 gy ended 11/09, 21 Catheters, Ileal Conduit Surgery 9/23/10

Tim G
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Date Joined Jul 2006
Total Posts : 2361
   Posted 12/16/2010 8:47 PM (GMT -6)   
My PCP had me see the urologist because of the PSA velocity, not due to the absolute number, which was still technically in the normal range for my age. 
 
The urologist repeated the PSA, did another DRE, then suggested a biopsy.
He said that at my relatively low PSA I did not need any scans.
 
I opted for treatment six months after the rise in PSA, rather than active surveillance, based on the velocity.
 
 

PSA quadrupled in one year (0.6 to 2.5)
DRE negative 1 of 12 biopsies positive (< 5%)
RRP surgery June 2006 at age 57
Organ-confined to small pea-sized area, Gleason 5
Bilateral nerve-sparing, prostate weight 34 grams
PSA < 0.1

Fairwind
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Date Joined Jul 2010
Total Posts : 3892
   Posted 12/16/2010 9:12 PM (GMT -6)   
Hindsight is always 20-20..My history speaks for itself..

First radiation treatment today, Varian Trilogy Rapid-Arc which probably does not make any difference, but it was a very interesting experience..
Age 68.
PSA at age 55: 3.5, DRE normal. Advice, "Keep an eye on it".
age 58: 4.5
" 61: 5.2
" 64: 7.5, DRE "Abnormal"
" 65: 8.5, " normal", biopsy, 12 core, negative...
" 66 9.0 "normal", 2ed biopsy, negative, BPH, Proscar
" 67 4.5 DRE "normal"
" 68 7.0 third biopsy positive, 4 out of 12, G-6,7, 9
RRP Sept 3 2010, pos margin, one pos vesicle nodes neg. Post Op PSA 0.9 SRT, HT, Dec

Ed C. (Old67)
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Date Joined Jan 2009
Total Posts : 2461
   Posted 12/17/2010 6:45 PM (GMT -6)   
Thanks for posting. I'm anxiously watching my PSA. At 65 my PSA was 1.65 at 66 it was 2.45 and at 67.5 it was 3.9 and at 68 it was 3.8. in all cases the DRE was negative and no other urological issues.
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